# Assessing the effects of manual therapy on pain in patients living with persistent non-specific low back pain (PNSLBP): Which evaluation criteria and measurement tools are used in randomised controlled clinical trials? A systematic review

Agathe Bilhaut, Anne-Hélène Olivier, Jerry Draper Rodi, Armel Crétual, Mathieu Ménard

► To cite this version:

Agathe Bilhaut, Anne-Hélène Olivier, Jerry Draper Rodi, Armel Crétual, Mathieu Ménard. Assessing the effects of manual therapy on pain in patients living with persistent non-specific low back pain (PNSLBP): Which evaluation criteria and measurement tools are used in randomised controlled clinical trials? A systematic review. International Journal of Osteopathic Medicine, 2025, 55, pp.100741. 10.1016/j.ijosm.2024.100741. hal-04888248

HAL Id: hal-04888248

https://hal.science/hal-04888248v1

Submitted on 17 Feb 2025

HAL is a multi-disciplinary open access
archive for the deposit and dissemination of sci-
entific research documents, whether they are pub-
lished or not. The documents may come from
teaching and research institutions in France or
abroad, or from public or private research centers.

L'archive ouverte pluridisciplinaire HAL, est
destinée au dépôt et à la diffusion de documents
scientifiques de niveau recherche, publiés ou non,
émanant des établissements d'enseignement et de
recherche français ou étrangers, des laboratoires
publics ou privés.

<figure><img src="image_1.png" /></figure>

Distributed under a Creative Commons Attribution 4.0 International License
**Title**

Assessing the effects of manual therapy on pain in patients living with Persistent Non-Specific Low Back Pain (PNSLBP): Which evaluation criteria and measurement tools used in randomised controlled clinical trials? A systematic review.

**Author names and affiliations.**

Agathe Bilhaut<fnref n="1" />*, Anne-Hélène Olivier<fnref n="1" />,<fnref n="4" />, Jerry Draper Rodi<fnref n="3" />, Armel Cretual<fnref n="1" />,<fnref n="4" />, Mathieu Ménard<fnref n="1" />,<fnref n="2" />

**\* Corresponding author.**

E-mail address: agathe.bilhaut@univ-rennes2.fr (A. Bilhaut).

**Present address.**

Laboratoire Mouvement Sport Santé (M2S), Université Rennes 2, 14 Avenue Robert Schuman, 35170, Bruz, France.

**Author Agreement**

All authors contributed to the conception and design of the study, analysis and interpretation of the data, drafting of the manuscript and critical revision, and gave their agreement to the final version of the manuscript submitted for publication. In addition, AHO, MM and AB acquired the data.

<footnote n="1">¹Univ Rennes, M2S - EA 7470, F-35000 Rennes, France.</footnote>

<footnote n="2">²Institut d'Ostéopathie de Rennes - Bretagne (IO-RB), Campus Rennes Atalante Ker-Lann, 50 rue Blaise Pascal, 35170 Bruz, France.</footnote>

<footnote n="3">³University College of Osteopathy (UCO), Research centre, 275 Borough High St, London SE1 1JE, United Kingdom.</footnote>

<footnote n="4">⁴Inria, Univ. Rennes, CNRS, IRISA, Rennes, France.</footnote>
**Abstract**

*Objective*

To identify the evaluation criteria and measurement tools that are used in Randomised Controlled Trials to assess the effects of manual therapy on pain in adults living with PNSLBP.

*Methods*

RCT were included if: participants were adults (18-65 years old) with PNSLBP, experimental group received manual therapies (osteopathy, physiotherapy and chiropractic) and they had been published in English or French since 2010. The search was conducted between May 2021 and April 2023, using the Cochrane Library, Ebscohost, EMBASE, MEDLINE Pubmed, PEDro, ScienceDirect and Scopus databases. Three independent reviewers have checked eligibility. The PEDro scale have been used for quality appraisal.

*Results*

In the 29 studies included, 131 measurement tools were identified in three main areas: 76% of the measurement tools were related to *life impact* (which 24% related to *pain intensity* and 23% to *functional difficulties*) and 24% were related to *pathophysiological manifestations* (which 8% related to *Range of motion*).

*Conclusion*

Most measurement tools focus on *pain intensity* and *physical functioning* using scales and questionnaires. Two perspectives must be considered: responding to current recommendations by standardizing the measurement tools relating to *life impact* and *physiopathological manifestations*, and using biomechanical markers making it possible to evaluate patients in daily life situations.

**Key Words**

Low Back Pain, Chronic Pain, Manual Therapies, Evaluation Criteria, Measurement Tools

**Main body of the paper**

**Introduction**

One of the most prevalent types of pain, and currently cited as one of the two main causes of disability worldwide, is low back pain (LBP) [1]. Most episodes of LBP are short-lived and resolve within 4 weeks, but if they persist for more than 12 weeks, they are considered to be chronic persistent [2]. 85%

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
of persistent LBP is defined as non-specific (PNSLBP), with no specific patho-anatomical cause [3]. PNSLBP is defined as primary persistent pain, which is characterised by pain associated with significant emotional distress or functional impairment that interferes with a patient's daily activities and participation in social roles [4]. PNSLBP is therefore considered as a disease in its own right [5].

The most recent recommendations on the management of PNSLBP suggest a multidisciplinary approach, involving general behavioural, pharmacological, psychological, rehabilitative and educational interventions, as well as the use of manual therapy [6]. The latter is supported by a moderate level of evidence, which may be explained by an insufficient number of high-quality trials [6].

Manual therapies are regarded as 'hands-on' practices involving body manipulation and mobilisation [7]. Those mobilisation techniques are described as "low-grade velocity, small or large amplitude passive movement techniques within the patient's range of motion and control", whereas the manipulation techniques are defined as "a force applied perpendicularly to the articular surfaces." [8].

However, their mechanisms of action are numerous [7] and are still the subject of much debate [9]. Two mechanisms related to two different processes are specifically discussed: a biomechanical process related to a decrease in internal constraints [10] and a neurophysiological process involved in a shift in pain regulation [11].

Recent editorials have opened the debate on the lack of evidence related to the "real mechanism" of manual therapy and proposed exploring new models such as the biopsychosocial and/or the enactive model [12,13]. While previous work has focused on the use of outcome measures in clinical studies by comparing them to guidelines for the management of chronic low back pain [14–16], to our knowledge there is no systematic review that is specifically interested in clinical studies relating to manual therapies. Most systematic reviews aim to investigate the effects of manual therapies, primarily focusing on efficacy [14,15]. Nevertheless, there is a significant heterogeneity in the parameters measured and the chosen measurement tools [14,15]. One of the key challenges would be to establish the required outcome domains for a core set of outcomes in clinical studies evaluating PNSLBP managed by manual therapy. Thus, the aim of our study is to list the set of assessment criteria and associated measurement tools in the management of LBP by manual therapies. Additionally, this present paper discusses how assessments can be improved.

## Methods

### Protocol and registration

This systematic review was conducted under the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [16] and registered with the Prospective Register of Systematic

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
Reviews (PROSPERO - Registration ID: CRD42021268722). The research question was: What evaluation criteria and measurement tools are used in RCT to evaluate the effects of manual therapy on pain in adults living with PNSLBP?

## Eligibility criteria

Trials were included according to the following inclusion criteria: (1) participants had to live with non-specific persistent low back pain and be aged between 18 and 65 (to exclude the potential effects of age [17]), (2) the effect of the intervention had to result from the following manual therapies: osteopathy, physiotherapy or chiropractic, (3) a control intervention needed to be used to compare the intervention (without intervention or sham intervention or control intervention) and participants had to be randomised into several groups, (4) at least one pain-related outcome measure had to be reported by the trials, (5) to have received ethics committee approval, they had to be published in full text in a peer-reviewed journal, (6) and they had to have been published in either English or French. Any trial meeting one of the following criteria was excluded: (1) participants living with acute or subacute low back pain and/or of specific or neuropathic origins and to be under 18 or over 65 years of age, (2) the intervention in the experimental group involved a therapy other than those listed in the inclusion criteria, (3) trials without a control group and not randomised or quasi-randomised, (4) results not relating to one of the components of pain (sensory-discriminative, emotional, cognitive and behavioural). This review systematically assessed trials published from 2010 onwards because it corresponds to the most recent systematic review to our knowledge that addressed the identification, description and evaluation of measurement tools for patients with chronic low back pain and to the articles that were published just before and after the recommendations for the use of a core outcome set for evaluating randomised controlled trials on the management of patients with chronic low back pain [18].

## Information sources

The search was conducted between May 2021 and April 2023, using the Cochrane Library, Ebscohost, EMBASE, MEDLINE Pubmed, PEDro, ScienceDirect and Scopus databases. The year 2010 was used as the cut-off point because the last systematic review identifying, describing, and evaluating standard outcome measures in patients with persistent low back pain assessing treatment success, was published in that year [19].

## Search strategy

The following keywords served as the basis for the search strategy, in accordance with the research question: target population, interventions, control conditions, outcomes and study designs of this review: low back pain AND chronic OR persistent AND Manual Therapy AND placebo control OR sham
control AND controlled clinical trials. Boundary: 2010-present (for more details on database search, see supplementary material 1).

### Selection process

The eligibility check was carried out by three independent reviewers. Any disagreement was settled by all the independent reviewers. The selection was made first using the title and abstract of the trials (1/uploading on Rayyan, 2/ duplicates removed and 3/ title and abstract screening), followed by screening the entire text of the remaining articles. A table summarizing the excluded studies and the reasons for their exclusion was added in supplementary material 2.

### Data collection process and data items

The data extraction process also required two independent reviewers, any resulting discrepancy being resolved through discussion or by a third independent reviewer. All the data from the selected trials were imported into a specially designed Excel spreadsheet (Microsoft), containing tables designed to be filled out with their bibliographical information (title, authors, date of publication and journal), the characteristics of the participants according to the control or experimental group (number of participants, age and female/male ratio), the description of the manual therapy and control group intervention, the evaluation criteria, the measurement tools and the risk of bias. The evaluation criteria and measurement tools were classified according to the recommendations defined by Chiarotto et al. [18] for clinical studies on the assessment of non-specific low back pain into four levels: "Core Areas", "Domains", "Evaluation Criteria", "Measurement Tools". Those recommendations are categorised into four core areas: death (the specific reason for the disease or intervention), *life impact* (including International Classification of Functionning, Disability and Health (ICF) domains [20] and domains relating to the concept of health-related quality of life), use of resources and economic impact (describing the economic impact of health problems on both society and the individual) and *pathophysiological manifestations* (reversible and irreversible manifestations and biomarkers) [18]. The domains defined by Chiarotto et al. [18] were listed in each of the core areas according to the evaluation criteria found in each study. Finally, the measurement tools used were listed for each evaluation criterion.

### Risk of bias

The PEDro scale [21] was used to assess methodological quality. The PEDro scale includes 11 methodological elements specific to RCT: 1) specification of eligibility criteria; 2) random assignment; 3) secret distribution; 4) basic comparability; leading the intervention without the 5) knowledge of the subjects; 6) therapists and 7) evaluators; 8) the completion of the study with measurements for at least 85% of the subjects; 9) analysis of data from all subjects enrolled at the start of the study; 10) statistical comparisons between groups; and 11) means and measures of variation. Each item is scored as 'yes' or
'no' and is worth 1 and 0 points respectively [21]. The total score of the PEDro scale corresponds to the number of 'yes' responses for items 2 to 11, i.e. a total score expressed out of 10 points. A deviation was made from the published PROSPERO protocol. We chose to use the PEDRO risk of bias scale rather than the RoB2 scale, because this scale is particularly useful for rehabilitation research [22]. In fact, the PEDro scale is less penalising for RCT evaluating the effectiveness of physical interventions, which cannot be carried out in triple blind [22]. The PEDro scale therefore integrates three of its constituent elements by assessing separately whether the subject, therapist and assessor are unaware of the intervention received (items 5 to 7) [21].

## Synthesis methods

A narrative format was used to summarise the findings of this systematic review. The research strategy was presented through a flow chart (Figure 1). The characteristics of the studies related to the population, the experimental and control groups, and the evaluation of the risk of bias were presented through tables (Tables 1 and 2). The characteristics of the studies in terms of country and year of publication were presented through figures (Figure 2 and 3). The results of the systematic review of evaluation criteria and measurement tools were summarised in Figures 4 and 5 and Tables 3 and 4.

## Results

### Study selection

The search strategy (Figure 1) identified 323 records in the Cochrane Library, 837 in Ebscohost, 140 in EMBASE, 845 in MEDLINE Pubmed, 427 in PEDro, 535 in ScienceDirect and 418 in Scopus, resulting in 2498 records without duplicates. According to the eligibility check, 29 trials were included (2390 records were excluded after screening titles and abstracts, and 67 after a full-text screening).

### Study characteristics

#### Year of publication

The earliest study included in this review was published in 2010 because it was our cut-off year. Since 2016, there has been an upward trend in the number of publications. The number of trials undergone per year is shown in Figure 2 and in supplementary material 3.

#### Country of origin

The publications included come from 12 different countries (Turkey, the United States of America, Spain, Brazil, Egypt, India, Italy, Saudi Arabia, China, Switzerland and Iran). All continents but Oceania are represented in this distribution. The most represented countries are Turkey (n = 5), the United States
of America (n = 4) and Spain (n = 4). The full geographical distribution of the included trials is shown
in Figure 3 and in supplementary material 3.

Population
---

The characteristics of the population are described in Table 1. 1954 participants in total were recruited
into the included trials, with a mean of 67.4 (+/- 60.2) participants per trial. On average, participants in
the control group were 38.97 years old and 50.08% female. For the intervention groups, the mean age
was 38.07 years and comprised 52.18% females.

Risk of bias in studies

The assessment of the included trials with the PEDro scale is shown in Table 2. Two were of excellent methodological quality [23,24]. The majority of trials (17 trials) presented a good methodological quality [25–41]. Nine were of moderate methodological quality [42–49]. The following quality evaluation criteria for these trials were lacking: “allocation concealed”, “subjects, therapists and assessors blinded”, “adequate follow-up” and “intention-to-treat analysis”. Two trials presented a low methodological quality [50,51].

Data synthesis

Evaluation criteria and measurement tools for all trials
***

A total of 131 measurement tools were listed and indexed in two Core Areas: *life impact* and *pathophysiological manifestations* (Figure 4.a. and Table 3). 99 measurement tools (76%) were organised in the *life impact* core area and classified into eleven domains: *pain intensity*, *physical functioning*, *health-related quality of life*, *cognitive functioning*, *satisfaction with treatment services*, *pain quality*, *psychological functioning*, *pain behaviour*, *medication*, *temporal aspect of pain* and *pain interference*. The two fields where measurement tools were most prevalent was *pain intensity* (31 measurement tools – 24%) measured mainly by self-administered scales (Visual Analogue Scale -VAS or Numerical Pain Rating Scale - NPRS) and *physical functioning* (30 measurement tools – 23%) measured solely by self-administered questionnaires (Oswestry Disability Questionnaire - ODI, Roland-Morris Disability Questionnaire - RMDQ, Quebec Back Pain questionnaire - QBP, Waddel Disability Index - WDI, Multidimensional Assessment Of Interoceptive Awareness - MAIA). 32 measurement tools (24%) were organised in the *pathophysiological manifestations* core area and classified into seven domains: *range of motion*, *pain biomarkers*, *spinal control*, *muscle endurance*, *muscle activity*, *body structure* and *proprioception* (Table 3). The field where measurement tools are most prevalent was the *range of motion* (11 measurement tools – 8%) assessed through trunk movements (Finger-to-Floor test, Schober test with modified versions) and measured mainly by a metre and *pain biomarkers* (7
measurement tools – 5%) assessing blood sample and measured by Electro Interstitial Scanner. All data
were available in supplementary material 3.

## Evaluation criteria and measuring tools used in trials with excellent and good methodological quality

A total of 96 measurement tools were listed and indexed in two Core Areas: *life impact* and *pathophysiological manifestations* (Figure 4.b. and Table 4). 72 measurement tools (75%) were organised in the *life impact* core area and classified into same eleven domains previously mentioned. The two fields where measurement tools were most prevalent was *pain intensity* (22 measurement tools – 23%) measured mainly by self-administered scales (VAS or NPRS) and *physical functioning* (21 measurement tools – 22%) measured solely by self-administered questionnaires (ODI, RMDQ, QBP, WDI, MAIA). 24 measurement tools (25%) were organised in the *pathophysiological manifestations* core area and classified into five domains: *range of motion, pain biomarkers, spinal control, muscle endurance and muscle activity* (Table 4). The field where measurement tools are most prevalent was the *range of motion* (7 measurement tools – 7%) assessed through trunk movements and measured mainly by a metre and *pain biomarkers* (7 measurement tools – 7%). All data were available in supplementary material 3.

## Evaluation criteria and measuring tools used in osteopathic trials only

There were trials dealing exclusively with osteopathic manipulation and/or mobilisation [38,45] (Figure 4. c. and in supplementary material 3). All of these trials used measurement tools to quantify *life impact*, in particular the following evaluation criteria: *pain intensity* (VAS, all trials), *physical functioning* (ODI: [38,45]) and *quality of life* (SF-12 : [38]). One trial looked at *pathophysiological manifestations*, focusing on *muscular activity* (EMG examination during trunk flexion-extension) and *range of motion* (Finger-to-Floor test) [45].

## Discussion

This systematic review aimed to explore the evaluation criteria and measurement tools used in RCT to assess the effect of manual therapy on pain in PNSLBP adults, allowing one to discuss the strengths and limitations of these tools and to propose new approaches to evaluate manual therapies.

### Summary of findings

Self-administered scales or questionnaires are the measurement tools most commonly used to measure the effect of manual therapy on pain. Out of the 131 measurement tools listed, 99 consist in self-administered scales or questionnaires, covering 18 evaluation criteria and including 30 different measurement tools. *Impact on life* was the core area that was most frequently represented, and the most frequently represented domains were *Pain intensity* and *Physical functioning*. When it comes to the
second most represented core area, *pathophysiological manifestations*, 18 evaluation criteria and 25 measurement tools were listed, and the most frequently represented domains were *Range of motion* and *Pain biomarkers*. With regard to the evaluation criteria and measurement tools used in trials with excellent and good methodological quality, the results are similar.

## Comparison with evidence-based recommendations

Authors of systematic reviews on the management of PNSLBP patients have reported that outcomes are often inconsistently measured and reported in RCTs [52]. One proposal to address this bias would be to use a standardised set of endpoints [52]. A core outcome set (COS) was proposed in 1998 by Deyo et al. [53] then updated in 2015 by Chiarotto et al. [18] and proposes specific recommendations for 4 outcome domains: *physical functioning, pain intensity, health-related quality of life* (HRQOL) and *number of deaths*. In this study, no trials reported on all four outcome domains, and none reported the number of deaths. Nine trials reported on the other three areas [26,31,33,36,38,42,44,46,48]. In addition to the evaluation criteria, the researchers must agree on the best tools for measuring these outcomes, making it possible to standardise and compare the results between studies [52]. Thus, a consensus has been reached (COMS) that the Numerical Rating Scale (NRS) should be used to assess pain intensity, the Oswestry Disability Index (ODI) version 2.1a or the 24-item Roland-Morris Disability Questionnaire (RMDQ) should be used to assess physical functioning, the Short-Form Health Survey 12 (SF-12) or the 10-item Patient-Reported Outcome Measurement Information System (PROMIS) for Global Health (PROMIS-GH-10) questionnaire should be used to assess HRQOL, and a simple report of the number of deaths that occurred during the trial should be used to report the number of deaths [54].

In this study, the two most reported scales to quantify the pain intensity are the Visual Analogue Scale (VAS) and the Numerical Pain Rating Scale (NPRS). These scales are reliable and valid [55] and show a strong correlation between them [56]. The VAS is more sensitive to change and the NRS is more reliable when used in specific populations such as older adults, people with cognitive disorders and people from low socio-educational levels [55,56]. The ability to administer the NRS verbally or in writing is another benefit [55]. Therefore, the administration conditions will determine which of these two scales is used: standardisation of anchoring descriptors (i.e. the descriptors defining the intensity of perceived pain), administration methods, time limits, interpretation of thresholds and clinical significance [56]. In addition to these scales, two other evaluation criteria (measurement tools) were identified: pain sensitivity (algometer) and amplitude of temporal summation (with VAS). These evaluation criteria aim to refine the parameters used to define pain sensitivity [59]. To our knowledge, there are no recommendations regarding the evaluation of pain sensitivity in the management of PNSLBP. Future work is still needed to include these variables, despite the growing number of trials and their findings, in particular those supporting a correlation between the psychological questionnaire scores and the level of pain sensitivity [57].

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65

When it comes to the *physical functioning* domain, the Roland Morris Disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI) were the two most commonly used questionnaires to quantify physical functioning. These questionnaires are considered to be reliable and valid [19,58,59]. The ODI focuses on how back pain affects an individual's ability to cope with their daily life and the RMDQ addresses the difficulties in performing daily physical activities that are directly related to low back pain [58]. While the RMDQ has less measurement error and better construct validity, the ODI has better test-retest reliability [58]. Conflicting evidence has been found concerning the sensitivity of the two instruments, and their internal consistency is unknown due to the methodological quality or lack of trials on this measurement's relevance/accuracy [58]. In fact, the ODI questionnaire consistently shows higher correlations with other instruments measuring identical or unrelated constructs such as perceived pain intensity, general health status, mental health and social functioning [58]. These findings suggest that the construct measured by the ODI may be broader than when measured by the RMDQ, the latter allowing one to measure a narrower construct and thus providing a more targeted evaluation of physical functioning in patients with low back pain [58]. There is therefore no compelling reason to favor one of these two tools over the other when assessing physical functioning in PNSLBP patients, but more reliable research is required to support this conclusion [58]. In addition to these questionnaires, three other evaluation criteria were identified: the Waddell Disability Index (WDI), the Quebec Back Pain Questionnaire (QBP) and the Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ). The WDI and QBP are easy to administer and to assess [60]. The WDI offers an advantage for clinical studies with its moderate test-retest reliability, good inter-rater reliability, concept validity, and data pooling capacity [60]. This index allows significant changes to be detected in patients after an interval of one month following treatment, but its reactivity has not been thoroughly investigated and it should be used in conjunction with other disability scoring systems to provide a comprehensive evaluation of pain [60]. The QBP is easy to administer and to assess, with high test-retest reliability, good content and construct validity, and has strong correlations with other disability tools (ODI, RMDQ) [60]. The OMPSQ is used to identify LBP patients at risk for chronicity and prolonged disability [60]. Although the OMPQS presents high reliability and used to be strongly correlated with recovery time [61], a recent review of the literature indicates that screening instruments for low back pain administered in primary care fail to assign higher risk scores to people who develop persistent pain and recommends new trials with larger cohorts and an extension of the control period [62].

In regards to the *health-related quality of life* domain, the 36-item Short Form Health Survey questionnaire (SF-36) was the most used one to assess the patients' Quality Of Life. The SF-36 measures their physical health (PCS) and mental health (MCS) [63]. Other self-administered questionnaires have been mentioned in this study: the Short Form (12) Health Survey, which is a shortened version of the SF-36 and measures the same eight health concepts [64], the EQ-5D-5L and the EQ-5D-3L, which cover mobility, personal care, usual activities, pain/discomfort and depression/anxiety associated with a
vertical visual analogue scale [65]. The difference between these last two measurement tools is the number of response options, 5 versus 3 [65]. At present, the current literature does not identify superior measurement properties for any of these tests for the evaluation of persistent low back pain, which is partly explained by the fact that these tools are not sufficiently specific when it comes to low back pain [59]. Thus, time is the primary factor that determines which of these scales should be used (SF-36 Health Survey includes more items).

## Biopsychosocial model

The trials also identified other evaluation categories where authors considered the contributions of biological, psychological, and social factors. Some trials investigated the biological factors, in particular brain metabolites, heart rate variability and hemodynamics. To our knowledge, there are no recommendations concerning these measurement tools. No study examined the social elements. Psychological factors were assessed using different domains such as cognitive functioning, pain quality, anxiety and depression and fear of movement. Cognitive functioning was assessed with two measurement tools: the Fear avoidance belief questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS). The FABQ measures the fear of pain caused by a patient's physical activity and is reliable and valid [66]. Specifically, it assesses his attitude towards physical activities and towards professional activities [66]. The PCS assesses three dimensions: rumination, amplification and helplessness [67]. Catastrophizing, a cognitive process in which nervous people focus on the worst possible outcomes, refers to this interpretation of pain as being exceedingly threatening [68]. Pain quality was assessed with Short-form McGill Pain (SF-MPQ) [69] and Brief Pain Inventory (BPI) [70] questionnaires, which are used to measure pain intensity as well as the qualitative aspects accompanying the pain. Psychological functioning was assessed by three questionnaires: Hospital Anxiety and Depression Scale (HADS) [71], Beck Depression Inventory (BDI) [74] and Patient Health Questionnaire-9 (PHQ-9) [72], which measures one's level of anxiety and depression. The fear of movement level was measured by the Tampa Scale Kinesiophobia (TSK) [73]. In clinical research, these scales and questionnaires provide an accurate picture of the symptoms that accompany pain. In addition, measurement tools such as FABQ [74], PCS [75], SF-MPQ [76], HADS [77], BPI [78], TSK [79] have been validated in a low back pain population.

## Biomechanical measurement tools

Another approach when assessing the consequences of PNSLBP is to conduct a biomechanical analysis of the patient. Thus, the trials focused on five areas: range of movement, spinal control, proprioception, muscular endurance and muscular activity. The range of movement, muscular endurance and muscular activity were assessed by asking the participants to perform trunk flexion-extension and/or lateral flexion. The patient's joint amplitude was measured mainly using a tape measure, their trunk control by
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65

using kinetic markers (body sway and analysis of different joints), his muscular endurance by the total
repetition score performed for a given movement and his proprioception by a dynamometer. The
evaluation criteria and measurement tools used are in line with the recent results of a systematic review
and meta-analysis which sought to identify a list of biomarkers relevant for differentiating patients with
PNSLBP from an asymptomatic population [80]. The results showed that range of motion, body sway
in the anterior-posterior axis, intersegmental and/or muscle coordination and variability were the most
relevant biomarkers for discriminating patients with low back pain [80]. Hence, no trial has considered
movements involving a displacement of the base of support, i.e. with displacement of the feet, which
does not allow us to assess painful subjects in a context close to the conditions encountered in one's
daily life. More and more studies are looking at the effect of low back pain on walking, and a recent
systematic review showed that PNSLBP patients had a slower comfort walking speed, a smaller range
of rotation in the pelvis and lumbar spine, and more in-phase coordination than asymptomatic subjects
[81]. In addition, motor difficulties in PNSLBP patients appear to be correlated with certain
psychological domains such as fear of movement, level of catastrophising and anxiety [68]. Thus,
measurement tools focusing on the patient's biomechanics seem relevant to assess, intervene on and
manage PNSLBP patients.

Strengths and limitations

To our knowledge, this systematic review is the first to identify and discuss the measurement tools used in manual therapy for the treatment of persistent non-specific low back pain. The entire study selection and data extraction process was carried out by three independent reviewers. However, there were several biases. The first was the narrowing of the eligibility criteria, and although this was intentional, only trials on general populations were included, leaving out trials on a particular profession, such as nursing or the army, which seemed to us to open up a different social context. Secondly, we decided to include only trials involving three manual therapies. Thirdly, we decided to select only trials published since 2010, which allows us to draw conclusions that are only valid for this period. Fourthly, Compared to the protocol described for PROSPERO, we modified the choice of the risk of bias scale for PEDro, which we felt was relevant given its widespread use in the literature for systematic reviews of manual therapies. Fifthly, we had initially included 3 studies led by Licciardone [82–84] but had to exclude them because the age of the participants was over 65. Interestingly, the overall results of the review were similar and perhaps age has less of an effect than expected. The issue of ageism in RCTs is not new (see for example [85]) and future research should consider whether it is useful and important to exclude older adults from reviews and trials with clear data, and if so, in what specific situations this should or should not happen.

Implications for research and education
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65

While questionnaires are commonly used to assess the effect of manual therapy in the context of pain management, one of the main findings of our study is that the assessment of patients’ functional capacity in everyday situations through movement analysis is not widely available in this literature. Indeed, several authors have proposed different types of assessments, mainly based on joint amplitude or muscular endurance. Although of major interest, these variables do not provide an exhaustive and complete view of the assessment of PNSLBP and notably patient’s daily life like walking for instance. As an example, previous work found that walkers take into account their anthropometric characteristics such as shoulder width [86], as well as their movement abilities [87] to perform an action in a specific environment, such as crossing through a door-like opening. If non-specific low back pain affects patients’ movement as well as their perception of their action capabilities [88], one could emphasise that the perception-action loop may be affected as a consequence. Designing new experimental models to assess low back pain in everyday tasks would allow us to expand on the findings from scales and questionnaires pertaining to the perceptual-motor approach of these patients, especially daily living activities.

An important area of research, particularly in osteopathic care, is the understanding and assessment of chronic pain in manual therapy settings. This means that it is essential to educate future osteopaths in how to determine treatment outcomes using affordable measurements [89] that can be applied in clinical settings, and to encourage future practitioners to participate in practice-based research networks to support in research efforts [90].

Conclusion

The present study provides new information on the evaluation criteria and measurement tools used in RCT to evaluate the effects of manual therapy on pain in adults living with PNSLBP. The primary findings indicate that, firstly, assessing its impact on one's life is the most commonly used evaluation criterion and, secondly, self-administered scales and questionnaires are the most commonly used measurement tools. Most of the questionnaires chosen were consistent with the existing literature and met the customary recommendations. A few trials also used assessment criteria relating to physiological manifestations, particularly the patient's amplitude of movement. However, although the tasks assessed were of major interest, they failed to draw an exhaustive and complete picture of how the PNSLBP was evaluated, particularly when it came to daily living activities, the challenges of which were made apparent by the questionnaires on physical functioning (walking, climbing stairs, sitting down, standing up). Finally, very few trials evaluated the effect of manual therapy by correlating the results obtained from scales and questionnaires with physiological manifestations. Trials still need to be set up to continue to evaluate the effect of manual therapy in order to further our understanding of these mechanisms and their action on the patient.
References

[1] T. Vos, et al., Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015, The Lancet 388 (2016) 1545–1602. https://doi.org/10.1016/S0140-6736(16)31678-6.

[2] M. Krismer, M. van Tulder, Low back pain (non-specific), Best Practice & Research Clinical Rheumatology 21 (2007) 77–91. https://doi.org/10.1016/j.berh.2006.08.004.

[3] P. O'Sullivan, Diagnosis and classification of chronic low back pain disorders: Maladaptive movement and motor control impairments as underlying mechanism, Manual Therapy 10 (2005) 242–255. https://doi.org/10.1016/j.math.2005.07.001.

[4] R.-D. Treede, W. Rief, A. Barke, Q. Aziz, M.I. Bennett, R. Benoliel, M. Cohen, S. Evers, N.B. Finnerup, M.B. First, M.A. Giamberardino, S. Kaasa, B. Korwisi, E. Kosek, P. Lavand'homme, M. Nicholas, S. Perrot, J. Scholz, S. Schug, B.H. Smith, P. Svensson, J.W.S. Vlaeyen, S.-J. Wang, Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11), Pain 160 (2019) 19–27. https://doi.org/10.1097/j.pain.0000000000001384.

[5] D.J. Clauw, M.N. Essex, V. Pitman, K.D. Jones, Reframing chronic pain as a disease, not a symptom: rationale and implications for pain management, Postgraduate Medicine 131 (2019) 185–198. https://doi.org/10.1080/00325481.2019.1574403.

[6] J.-Y. Hong, K.-S. Song, J.H. Cho, J.H. Lee, N.H. Kim, An Updated Overview of Low Back Pain Management, Asian Spine J 16 (2022) 968–982. https://doi.org/10.31616/asj.2021.0371.

[7] G. Bronfort, M. Haas, R. Evans, G. Kawchuk, S. Dagenais, Evidence-informed management of chronic low back pain with spinal manipulation and mobilization, The Spine Journal (2008) 13.

[8] D.W. Evans, N. Lucas, What is manipulation? A new definition, BMC Musculoskelet Disord 24 (2023) 194. https://doi.org/10.1186/s12891-023-06298-w.

[9] S.M. Rubinstein, M. van Middelkoop, W.J.J. Assendelft, M.R. de Boer, M.W. van Tulder, Spinal Manipulative Therapy for Chronic Low-Back Pain, (2011).

[10] H. Franke, J.-D. Franke, G. Fryer, Osteopathic manipulative treatment for nonspecific low back pain: a systematic review and meta-analysis, BMC Musculoskeletal Disorders 15 (2014) 286. https://doi.org/10.1186/1471-2474-15-286.

[11] R. Pelletier, D. Bourbonnais, J. Higgins, Nociception, pain, neuroplasticity and the practice of Osteopathic Manipulative Medicine, International Journal of Osteopathic Medicine 27 (2018) 34–44. https://doi.org/10.1016/j.ijosm.2017.08.001.

[12] J.P. Caneiro, E.M. Roos, C.J. Barton, K. O'Sullivan, P. Kent, I. Lin, P. Choong, K.M. Crossley, J. Hartvigsen, A.J. Smith, P. O'Sullivan, It is time to move beyond ‘body region silos’ to manage musculoskeletal pain: five actions to change clinical practice, Br J Sports Med 54 (2020) 438–439. https://doi.org/10.1136/bjsports-2018-100488.
[13]J.E. Esteves, R. Zegarra-Parodi, P. van Dun, F. Cerritelli, P. Vaucher, Models and theoretical frameworks for osteopathic care – A critical view and call for updates and research, International Journal of Osteopathic Medicine 35 (2020) 1–4. https://doi.org/10.1016/j.ijosm.2020.01.003.

[14]C. Clar, A. Tsertsvadze, R. Court, G.L. Hundt, A. Clarke, P. Sutcliffe, Clinical effectiveness of manual therapy for the management of musculoskeletal and non-musculoskeletal conditions: systematic review and update of UK evidence report, Chiropr Man Therap 22 (2014) 12. https://doi.org/10.1186/2045-709X-22-12.

[15]D. Bagagiolo, C.G. Priolo, E.M. Favre, A. Pangallo, A. Didio, M. Sbarbaro, T. Borro, S. Daccò, P. Manzoni, D. Farina, A Randomized Controlled Trial of Osteopathic Manipulative Therapy to Reduce Cranial Asymmetries in Young Infants with Nonsynostotic Plagiocephaly, Am J Perinatol 39 (2022) S52–S62. https://doi.org/10.1055/s-0042-1758723.

[16]M.J. Page, J.E. McKenzie, P.M. Bossuyt, I. Boutron, T.C. Hoffmann, C.D. Mulrow, L. Shamseer, J.M. Tetzlaff, E.A. Akl, S.E. Brennan, R. Chou, J. Glanville, J.M. Grimshaw, A. Hróbjartsson, M.M. Lalu, T. Li, E.W. Loder, E. Mayo-Wilson, S. McDonald, L.A. McGuinness, L.A. Stewart, J. Thomas, A.C. Tricco, V.A. Welch, P. Whiting, D. Moher, The PRISMA 2020 statement: An updated guideline for reporting systematic reviews, International Journal of Surgery 88 (2021) 105906. https://doi.org/10.1016/j.ijsu.2021.105906.

[17]C. Murray, K. Patel, H. Twiddy, J. Sturgeon, T. Palermo, Age differences in cognitive–affective processes in adults with chronic pain., European Journal of Pain 25 (2021) 1041–1052. https://doi.org/10.1002/ejp.1725.

[18]A. Chiarotto, R.A. Deyo, C.B. Terwee, M. Boers, R. Buchbinder, T.P. Corbin, L.O.P. Costa, N.E. Foster, M. Grotle, B.W. Koes, F.M. Kovacs, C.-W.C. Lin, C.G. Maher, A.M. Pearson, W.C. Peul, M.L. Schoene, D.C. Turk, M.W. van Tulder, R.W. Ostelo, Core outcome domains for clinical trials in non-specific low back pain, Eur Spine J 24 (2015) 1127–1142. https://doi.org/10.1007/s00586-015-3892-3.

[19]J.R. Chapman, D.C. Norvell, J.T. Hermsmeyer, R.J. Bransford, J. DeVine, M.J. McGirt, M.J. Lee, Evaluating Common Outcomes for Measuring Treatment Success for Chronic Low Back Pain: Spine 36 (2011) S54–S68. https://doi.org/10.1097/BRS.0b013e31822ef74d.

[20]World Health Organization, International Classification of Functioning, Disability and Health: ICF, World Health Organization, 2001.

[21]L. Brosseau, C. Laroche, A. Sutton, P. Guitard, J. King, S. Poitras, L. Casimiro, M. Tremblay, D. Cardinal, S. Cavallo, L. Laferrière, I. Grisé, L. Marshall, J.R. Smith, J. Lagacé, D. Pharand, R. Galipeau, K. Toupin-April, L. Loew, C. Demers, K. Sauvé-Schenk, N. Paquet, J. Savard, J. Tourigny, V. Vaillancourt, Une version franco-canadienne de la Physiotherapy Evidence Database (PEDro) Scale : L'Échelle PEDro, Physiotherapy Canada 67 (2015) 232–239. https://doi.org/10.3138/ptc.2014-37F.
[22] A.M. Moseley, M.B. Pinheiro, Research Note: Evaluating risk of bias in randomised controlled trials, Journal of Physiotherapy 68 (2022) 148-150. https://doi.org/10.1016/j.jphys.2022.02.003.

[23] M.D. Arguisuelas, J.F. Lisón, D. Sánchez-Zuriaga, I. Martínez-Hurtado, J. Doménech-Fernández, Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial, Spine 42 (2017) 627-634. https://doi.org/10.1097/BRS.00000000000001897.

[24] M. Martí-Salvador, L. Hidalgo-Moreno, J. Doménech-Fernández, J.F. Lisón, M.D. Arguisuelas, Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial, Archives of Physical Medicine and Rehabilitation 99 (2018) 1720-1729. https://doi.org/10.1016/j.apmr.2018.04.022.

[25] Ahmed UA, Maharaj SS, Van Oosterwijck J, Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial., Scand J Pain 21 (2021) 495-511. https://doi.org/10.1515/sjpain-2020-0133.

[26] T.A. Boff, F. Pasinato, Â.J. Ben, J.E. Bosmans, M. van Tulder, R.L. Carregaro, Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial, Physiotherapy 107 (2020) 71-80. https://doi.org/10.1016/j.physio.2019.11.002.

[27] A.M. Castro-Sánchez, I.C. Lara-Palomo, G.A. Matarán-Peñarrocha, M. Saavedra-Hernández, J.M. Pérez-Mármol, M.E. Aguilar-Ferrándiz, Benefits of Craniosacral Therapy in Patients with Chronic Low Back Pain: A Randomized Controlled Trial, The Journal of Alternative and Complementary Medicine 22 (2016) 650-657. https://doi.org/10.1089/acm.2016.0068.

[28] Didehdar D, Kamali F, Yoosefinejad AK, Lotfi M, The effect of spinal manipulation on brain neurometabolites in chronic nonspecific low back pain patients: a randomized clinical trial., Ir J Med Sci 189 (2020) 543-550.

[29] J. Fagundes Loss, L. De Souza Da Silva, I. Ferreira Miranda, S. Groisman, E. Santiago Wagner Neto, C. Souza, C. Tarragô Candotti, Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial, Chiropr Man Therap 28 (2020) 25. https://doi.org/10.1186/s12998-020-00316-7.

[30] M. Grande-Alonso, L. Suso-Martí, F. Cuenca-Martínez, J. Pardo-Montero, A. Gil-Martínez, R. La Touche, Physiotherapy Based on a Biobehavioral Approach with or Without Orthopedic Manual Physical Therapy in the Treatment of Nonspecific Chronic Low Back Pain: A Randomized Controlled Trial, Pain Medicine 20 (2019) 2571-2587. https://doi.org/10.1093/pm/pnz093.

[31] G. Nambi, W. Kamal, S. Es, S. Joshi, P. Trivedi, Spinal manipulation plus laser therapy versus laser therapy alone in the treatment of chronic non-specific low back pain: a randomized controlled study, Eur J Phys Rehabil Med 54 (2019). https://doi.org/10.23736/S1973-9087.18.05005-0.
[32] J. Zafereo, S. Wang-Price, T. Roddey, K. Brizzolara, Regional manual therapy and motor control exercise for chronic low back pain: a randomized clinical trial, Journal of Manual and Manipulative Therapy 26 (2018) 193-202.

[33] F. Zangrando, G. Piccinini, C. Tagliolini, G. Marsilli, M. Iosa, M.C. Vulpiani, T. Paolucci, The efficacy of a preparatory phase of a touch-based approach in treating chronic low back pain: a randomized controlled trial, JPR Volume 10 (2017) 941-949. https://doi.org/10.2147/JPR.S129313.

[34] H.M. Hussein, A.A. Morsi, N.A. Abdelraoof, The immediate effect of sustained natural apophyseal glide on postural stability and pain in individuals presenting with flexion-dominant chronic low back pain: A randomized single-blinded placebo-controlled trial, BMR 34 (2021) 1079-1086. https://doi.org/10.3233/BMR-200217.

[35] K.K. Sarker, J. Sethi, U. Mohanty, Effect of Spinal Manipulation on Pain Sensitivity, Postural Sway, and Healthrelated Quality of Life among Patients with Non-specific Chronic Low Back Pain: A Randomised Control Trial, JCDR (2019). https://doi.org/10.7860/JCDR/2019/38074.12578.

[36] M.K. Senna, S.A. Machaly, Does Maintained Spinal Manipulation Therapy for Chronic Nonspecific Low Back Pain Result in Better Long-Term Outcome?: Spine 36 (2011) 1427-1437. https://doi.org/10.1097/BRS.0b013e3181f5dfe0.

[37] M.D. Arguisuelas, J.F. Lisón, J. Doménech-Fernández, I. Martínez-Hurtado, P. Salvador Coloma, D. Sánchez-Zuriaga, Effects of myofascial release in erector spinae myoelectric activity and lumbar spine kinematics in non-specific chronic low back pain: Randomized controlled trial, Clinical Biomechanics 63 (2019) 27-33. https://doi.org/10.1016/j.clinbiomech.2019.02.009.

[38] K. Auger, G. Shedlock, K. Coutinho, N.E. Myers, S. Lorenzo, Effects of osteopathic manipulative treatment and bio-electromagnetic energy regulation therapy on lower back pain, Journal of Osteopathic Medicine 121 (2021) 561-569. https://doi.org/10.1515/jom-2020-0132.

[39] P. Balthazard, P. de Goumoens, G. Rivier, P. Demeulenaere, P. Ballabeni, O. Dériaz, Manual therapy followed by specific active exercises versus a placebo followed by specific active exercises on the improvement of functional disability in patients with chronic non specific low back pain: a randomized controlled trial, BMC Musculoskelet Disord 13 (2012) 162. https://doi.org/10.1186/1471-2474-13-162.

[40] J.S. Thomas, B.C. Clark, D.W. Russ, C.R. France, R. Ploutz-Snyder, D.M. Corcos, for the RELIEF Study Investigators, Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial, JAMA Netw Open 3 (2020) e2012589. https://doi.org/10.1001/jamanetworkopen.2020.12589.

[41] I. Saracoglu, M.I. Arik, E. Afsar, H.H. Gokpinar, The effectiveness of pain neuroscience education combined with manual therapy and home exercise for chronic low back pain: A single-blind randomized controlled trial, Physiotherapy Theory and Practice 38 (2022) 868-878. https://doi.org/10.1080/09593985.2020.1809046.
[42]S.T. Celenay, D.O. Kaya, S.G. Ucurum, Adding connective tissue manipulation to physiotherapy for chronic low back pain improves pain, mobility, and well-being: a randomized controlled trial, (2019) 8.

[43]H.M. Hussien, N.A. Abdel-Raoof, O.M. Kattabei, H.H. Ahmed, Effect of Mulligan Concept Lumbar SNAG on Chronic Nonspecific Low Back Pain, Journal of Chiropractic Medicine 16 (2017) 94-102.

[44]S. Tamer, M. Öz, Ö. Ülger, The effect of visceral osteopathic manual therapy applications on pain, quality of life and function in patients with chronic nonspecific low back pain, BMR 30 (2017) 419-425. https://doi.org/10.3233/BMR-150424.

[45]Bicalho E, Setti JA, Macagnan J, Cano JL, Manffra EF, Immediate effects of a high-velocity spine manipulation in paraspinal muscles activity of nonspecific chronic low-back pain subjects., Man Ther 15 (2010) 469-75.

[46]Branchini M; Lopopolo F; Andreoli E; Loreti I; Marchand AM; Stecco A, Fascial manipulation for chronic aspecific low back pain: a single blinded randomized controlled trial, F1000Research 2016 Nov 3;4(1208):Epub (2016).

[47]D. Endamlı, K. Bayramlar, B. Turhan, Investigation of fascial treatment effectiveness on pain, flexibility, functional level, and kinesiophobia in patients with chronic low back pain, Pq 27 (2019) 1-5. https://doi.org/10.5114/pq.2019.86461.

[48]S. Joshi, R. Yadav, A. Pawalia, Can a cervical muscle inhibition technique reduce chronic low back pain?, Areh 35 (2021) 38-46. https://doi.org/10.5114/areh.2021.111112.

[49]Yagci N; Simsek S; Telci EA; Cubukcu MM, The effect of soft tissue mobilization on pain, disability level, and depressive symptoms in patients with chronic low back pain, The Annals of Clinical and Analytical Medicine 2020 Jul;11(4):257-261 (2020).

[50]Divya, A. Parveen, S. Nuhmani, M. Ejaz Hussain, M. Hussain Khan, Effect of lumbar stabilization exercises and thoracic mobilization with strengthening exercises on pain level, thoracic kyphosis, and functional disability in chronic low back pain, Journal of Complementary and Integrative Medicine 18 (2021) 419-424. https://doi.org/10.1515/jcim-2019-0327.

[51]S.-Q. Wang, M. Chen, X. Wei, X.-X. Gao, G.-D. Zhao, Clinical research on lumbar oblique-pulling manipulation in combination with sling exercise therapy for patients with chronic nonspecific low back pain, Rev. Assoc. Med. Bras. 65 (2019) 886-892. https://doi.org/10.1590/1806-9282.65.6.886.

[52]T. Innocenti, S. Salvioli, P. Logullo, S. Giagio, R. Ostelo, A. Chiarotto, The Uptake of the Core Outcome Set for Non-Specific Low Back Pain Clinical Trials is Poor: A Meta-Epidemiological Study of Trial Registrations, The Journal of Pain (2023) S1526590023005102. https://doi.org/10.1016/j.jpain.2023.08.006.

[53]R. Deyo, M. Battie, A. Beurskens, C. Bombardier, P. Croft, B. Koes, A. Malmivaara, M. Roland, M. Von Korff, G. Waddell, Outcome measures for low back pain research: a proposal for standardized use., Spine 23 (1998) 2003-2013.
[54] A. Chiarotto, M. Boers, R.A. Deyo, R. Buchbinder, T.P. Corbin, L.O.P. Costa, N.E. Foster, M. Grotle, B.W. Koes, F.M. Kovacs, C.-W.C. Lin, C.G. Maher, A.M. Pearson, W.C. Peul, M.L. Schoene, D.C. Turk, M.W. van Tulder, C.B. Terwee, R.W. Ostelo, Core outcome measurement instruments for clinical trials in nonspecific low back pain, Pain 159 (2018) 481-495.
https://doi.org/10.1097/j.pain.0000000000001117.

[55] R.J. Santiago, J. Esteves, J.S. Baptista, A.T. Marques, J.T. Costa, Instrumentation used to assess pain in osteopathic interventions: A critical literature review, International Journal of Osteopathic Medicine 0 (2020). https://doi.org/10.1016/j.ijosm.2020.05.007.

[56] M.J. Hjermstad, P.M. Fayers, D.F. Haugen, A. Caraceni, G.W. Hanks, J.H. Loge, R. Fainsinger, N. Aass, S. Kaasa, Studies Comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for Assessment of Pain Intensity in Adults: A Systematic Literature Review, Journal of Pain and Symptom Management 41 (2011) 1073-1093.
https://doi.org/10.1016/j.jpainsymman.2010.08.016.

[57] S.M. Meints, I. Mawla, V. Napadow, J. Kong, J. Gerber, S.-T. Chan, A.D. Wasan, T.J. Kaptchuk, C. McDonnell, J. Carriere, B. Rosen, R.L. Gollub, R.R. Edwards, The relationship between catastrophizing and altered pain sensitivity in patients with chronic low-back pain, Pain 160 (2019) 833-843.
https://doi.org/10.1097/j.pain.0000000000001461.

[58] A. Chiarotto, L.J. Maxwell, C.B. Terwee, G.A. Wells, P. Tugwell, R.W. Ostelo, Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis, Physical Therapy 96 (2016) 1620-1637.
https://doi.org/10.2522/ptj.20150420.

[59] A. Chiarotto, C.B. Terwee, R.W. Ostelo, Choosing the right outcome measurement instruments for patients with low back pain, Best Practice & Research Clinical Rheumatology 30 (2016) 1003-1020.
https://doi.org/10.1016/j.berh.2017.07.001.

[60] A. Garg, H. Pathak, M.V. Churyukanov, R.B. Uppin, T.M. Slobodin, Low back pain: critical assessment of various scales, Eur Spine J 29 (2020) 503-518.
https://doi.org/10.1007/s00586-019-06279-5.

[61] C.P. Gabel, M. Melloh, B. Burkett, J. Osborne, M. Yelland, The Örebro Musculoskeletal Screening Questionnaire: Validation of a modified primary care musculoskeletal screening tool in an acute work injured population, Manual Therapy 17 (2012) 554-565.
https://doi.org/10.1016/j.math.2012.05.014.

[62] E.L. Karran, J.H. McAuley, A.C. Traeger, S.L. Hillier, L. Grabherr, L.N. Russek, G.L. Moseley, Can screening instruments accurately determine poor outcome risk in adults with recent onset low back pain? A systematic review and meta-analysis, BMC Med 15 (2017) 13.
https://doi.org/10.1186/s12916-016-0774-4.
[63] R. LoMartire, B.O. Äng, B. Gerdle, L. Vixner, Psychometric properties of Short Form-36 Health Survey, EuroQol 5-dimensions, and Hospital Anxiety and Depression Scale in patients with chronic pain, Pain 161 (2020) 83–95. https://doi.org/10.1097/j.pain.0000000000001700.

[64] D.L. Riddle, J.K. Freburger, Evaluation of the presence of sacroiliac joint region dysfunction using a combination of tests: a multicenter intertester reliability study, Phys Ther 82 (2002) 772–781.

[65] B. van Hout, M.F. Janssen, Y.-S. Feng, T. Kohlmann, J. Busschbach, D. Golicki, A. Lloyd, L. Scalone, P. Kind, A.S. Pickard, Interim Scoring for the EQ-5D-5L: Mapping the EQ-5D-5L to EQ-5D-3L Value Sets, Value in Health 15 (2012) 708–715. https://doi.org/10.1016/j.jval.2012.02.008.

[66] M.M. Wertli, E. Rasmussen-Barr, S. Weiser, L.M. Bachmann, F. Brunner, The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review, The Spine Journal 14 (2014) 816-836.e4. https://doi.org/10.1016/j.spinee.2013.09.036.

[67] M.J.L. Sullivan, S. Bishop S.R., J. Pivik, The pain catastrophizing scale: development and validation., Psychological Assessment 7 (1995) 524. https://doi.org/10.1037/1040-3590.7.4.524.

[68] G. Christe, G. Crombez, S. Edd, E. Opsommer, B.M. Jolles, J. Favre, Relationship between psychological factors and spinal motor behaviour in low back pain: a systematic review and meta-analysis, Pain 162 (2021) 672–686. https://doi.org/10.1097/j.pain.0000000000002065.

[69] R. Melzack, The short-form McGill pain questionnaire:, Pain 30 (1987) 191–197.
https://doi.org/10.1016/0304-3959(87)91074-8.

[70] C.S. Cleeland, K. Ryan, Pain assessment: global use of the Brief Pain Inventory, Annals of the Academy of Medicine, Singapore 23 (1994) 129–138.

[71] A.S. Zigmond, R.P. Snaith, The Hospital Anxiety and Depression Scale, Acta Psychiatr Scand 67 (1983) 361–370. https://doi.org/10.1111/j.1600-0447.1983.tb09716.x.

[72] K. Kroenke, R.L. Spitzer, J.B.W. Williams, The PHQ-9: Validity of a brief depression severity measure, J Gen Intern Med 16 (2001) 606–613. https://doi.org/10.1046/j.1525-1497.2001.016009606.x.

[73] M.K.E. Lundberg, J. Styf, S.G. Carlsson, A psychometric evaluation of the Tampa Scale for Kinesiophobia — from a physiotherapeutic perspective, Physiotherapy Theory and Practice 20 (2004) 121–133. https://doi.org/10.1080/09593980490453002.

[74] G. Waddell, M. Newton, I. Henderson, D. Somerville, C.J. Main, A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability, Pain 52 (1993) 157–168. https://doi.org/10.1016/0304-3959(93)90127-B.

[75] S. Van Damme, G. Crombez, P. Bijttebier, L. Goubert, B. Van Houdenhove, A confirmatory factor analysis of the Pain Catastrophizing Scale: invariant factor structure across clinical and non-clinical populations, Pain 96 (2002) 319–324. https://doi.org/10.1016/S0304-3959(01)00463-8.

[76] R.H. Dworkin, D.C. Turk, J.J. Trudeau, C. Benson, D.M. Biondi, N.P. Katz, M. Kim, Validation of the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) in Acute Low Back Pain, The Journal of Pain 16 (2015) 357–366. https://doi.org/10.1016/j.jpain.2015.01.012.
[77] J. Trudeau, D. Turk, R. Dworkin, C. Benson, D. Biondi, M. Kim, J. Mou, N. Katz, Validation of the Hospital Anxiety and Depression Scale (HADS) in patients with acute low back pain, The Journal of Pain 13 (2012) S24. https://doi.org/10.1016/j.jpain.2012.01.105.

[78] C.-Y. Song, S.-F. Lin, C.-Y. Huang, H.-C. Wu, C.-H. Chen, C.-L. Hsieh, Validation of the Brief Pain Inventory in Patients With Low Back Pain, Spine 41 (2016) E937-E942. https://doi.org/10.1097/BRS.0000000000001478.

[79] J.W.S. Vlaeyen, A.M.J. Kole-Snijders, R.G.B. Boeren, H. van Eek, Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance, Pain 62 (1995) 363-372. https://doi.org/10.1016/0304-3959(94)00279-N.

[80] F. Moissenet, K. Rose-Dulcina, S. Armand, S. Genevay, A systematic review of movement and muscular activity biomarkers to discriminate non-specific chronic low back pain patients from an asymptomatic population, Sci Rep 11 (2021) 5850. https://doi.org/10.1038/s41598-021-84034-x.

[81] C. Koch, F. Hänsel, Chronic Non-specific Low Back Pain and Motor Control During Gait, Front. Psychol. 9 (2018) 2236. https://doi.org/10.3389/fpsyg.2018.02236.

[82] J.C. Licciardone, C.M. Kearns, L.M. Hodge, M.V.W. Bergamini, Associations of Cytokine Concentrations With Key Osteopathic Lesions and Clinical Outcomes in Patients With Nonspecific Chronic Low Back Pain: Results From the OSTEOPATHIC Trial, J Am Osteopath Assoc 112 (2012) 596. https://doi.org/10.7556/jaoa.2012.112.9.596.

[83] J.C. Licciardone, D.E. Minotti, R.J. Gatchel, C.M. Kearns, K.P. Singh, Osteopathic Manual Treatment and Ultrasound Therapy for Chronic Low Back Pain: A Randomized Controlled Trial, The Annals of Family Medicine 11 (2013) 122-129. https://doi.org/10.1370/afm.1468.

[84] J.C. Licciardone, R.J. Gatchel, S. Aryal, Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial, J Am Osteopath Assoc 116 (2016) 144. https://doi.org/10.7556/jaoa.2016.031.

[85] G. Godlovitch, Age discrimination in trials and treatment: Old dogs and new tricks, Monash Bioethics Review (2003) 66-77.

[86] T. Higuchi, M.E. Cinelli, M.A. Greig, A.E. Patla, Locomotion through apertures when wider space for locomotion is necessary: adaptation to artificially altered bodily states, Exp Brain Res 175 (2006) 50-59. https://doi.org/10.1007/s00221-006-0525-4.

[87] K. Wilmut, W. Du, A.L. Barnett, How Do I Fit through That Gap? Navigation through Apertures in Adults with and without Developmental Coordination Disorder, PLoS ONE 10 (2015) e0124695. https://doi.org/10.1371/journal.pone.0124695.

[88] A. Bilhaut, M. Ménard, O. Roze, A. Crétual, A.-H. Olivier, Locomotion behavior of chronic Non-Specific Low Back Pain (cNSLBP) participants while walking through apertures, Gait & Posture 104 (2023) 140-146. https://doi.org/10.1016/j.gaitpost.2023.06.015.

[89] T. Bagory, P. Vaucher, H. Mhadhbi, M. Ménard, Exploring the utility of motion analysis in osteopathic clinical trials; a school-based pilot study on jaw and cervical range of motion,
International Journal of Osteopathic Medicine 41 (2021) 27-36.
https://doi.org/10.1016/j.ijosm.2021.05.007.

[90] A. Steel, W. Peng, D. Sibbritt, J. Adams, Introducing national osteopathy practice-based research networks in Australia and New Zealand: an overview to inform future osteopathic research, Sci Rep 10 (2020) 846. https://doi.org/10.1038/s41598-020-57918-7.
<figure><img src="image_2.png" /></figure>
<caption>Figure 3</caption>

Click here to access/download:Figure 3.jpg

<figure><img src="image_3.png" /></figure>
<figure><img src="image_4.png" /></figure>

<figure><img src="image_5.png" /></figure>

<figure><img src="image_6.png" /></figure>
**Figure 1.** Preferred Reporting Items for Systematic Review and Meta-Analysis flow diagram showing the identification, screening, and selection process of records for this systematic review. Reasons for exclusion at the full-text eligibility screening phase are provided.

**Figure 2.** Number of trials published between 2010 and 2023.

**Figure 3.** Country of origin of trials included.

**Figure 4.** Core Areas, Domains, Parameters and measurement tools for all included trials (a), for trials with excellent and good methodological quality (b) and for osteopathic trials only (c).

**sTables 1.** Characteristics of the population.

**Table 2.** The assessment of Risk Of Bias (ROB) of included trials with the PEDro scale.

**Table 3.** Occurrence frequency of measurement tools listed in *life impact* core area, in *pathophysiological manifestations* and in *resource use/economical impact* for all included trials.

**Table 4.** Occurrence frequency of measurement tools listed in *life impact* core area, in *pathophysiological manifestations* and in *resource use/economical impact* for trials with excellent and good methodological quality.
<figure><img src="image_7.png" /></figure>
<caption>Table 1</caption>

Click here to access/download:Table (Editable version):Table

<figure><img src="image_8.png" /></figure>

<table><thead><tr><th rowspan="2">Trials</th><th rowspan="2">Number of participants (n)</th><th rowspan="2">CG</th><th rowspan="2">EG</th><th colspan="2">1.docx</th><th colspan="2">Female (%)</th></tr><tr><th colspan="2">Age (mean ± sd)</th><th colspan="2"></th></tr><tr><th></th><th></th><th></th><th></th><th>CG</th><th>EG</th><th>CG</th><th>EG</th></tr></thead><tbody><tr><td>(Endamli et al., 2019)</td><td>55</td><td>PT</td><td>PT+ FR</td><td>37.93 ± 10.87</td><td>37.14 ± 11.56</td><td>-</td><td>-</td></tr><tr><td>(Branchini et al., 2016)</td><td>24</td><td>PT</td><td>PT + FR</td><td>44 (8.2)</td><td>48 (12)</td><td>69.2</td><td>63.6</td></tr><tr><td>(Arguisuelas et al., 2017)</td><td>54</td><td>Sham MFR</td><td>MFR</td><td>46.4 (11.4)</td><td>46.6 (10.3)</td><td>62.9</td><td>40.7</td></tr><tr><td>(Arguisuelas et al., 2019)</td><td>36</td><td>Sham MFR</td><td>MFR</td><td>48.6 (10.1)</td><td>47.2 (9.8)</td><td>66.7</td><td>66.7</td></tr><tr><td>(Boff et al., 2020)</td><td>72</td><td>HVLA</td><td>MFR</td><td>38.7 (6.8)</td><td>38.1 (7.0)</td><td>17</td><td>19</td></tr><tr><td>(Auger et al., 2021)</td><td>40</td><td>Sham MFR<br>Sham BEMER</td><td>1) MFR<br>2) BEMER<br>3) MFR + BEMER</td><td>25.3±1.6</td><td>1) 25.9±2.5<br>2) 24.6±1.6<br>3) 24.8±1.8</td><td>60</td><td>1) 40<br>2) 50<br>3) 60</td></tr><tr><td>(Castro-Sánchez et al., 2016)</td><td>64</td><td>Light massage</td><td>CrT</td><td>53±9</td><td>50±11</td><td>59.4</td><td>71.8</td></tr><tr><td>(Martí-Salvador et al., 2018)</td><td>66</td><td>Sham DI + OMT</td><td>DI + OMT</td><td>41.7 ± 10.3</td><td>43.4 ± 10.8</td><td>60.6</td><td>51.5</td></tr><tr><td>(Hussien et al., 2017)</td><td>42</td><td>PT</td><td>PT + lumbar SNAG</td><td>28.9 ± 7.7</td><td>27.1 ± 8.3</td><td>31.6</td><td>13</td></tr><tr><td>(Hussein et al., 2021)</td><td>64</td><td>Sham SNAG</td><td>SNAG</td><td>22.00 ± 1.4</td><td>22.00 ± 1.46</td><td>-</td><td>-</td></tr><tr><td>(Ahmed et al., 2021)</td><td>137</td><td>PT</td><td>1) MET + DSE<br>2) DSE</td><td>41.22 ± 8.4</td><td>1) 38.76 ± 9.87<br>2) 39.21 ± 8.62</td><td>28.9</td><td>1) 43.9<br>2) 35.9</td></tr><tr><td>(Divya et al., 2021)</td><td>-</td><td>CT + LSE</td><td>TMSE<br>+ CT + LSE</td><td>40.33 ± 8.6</td><td>38.53 ± 7.8</td><td>-</td><td>-</td></tr><tr><td>(Yagci et al., 2020)</td><td>112</td><td>PT</td><td>PT + Soft Tissue<br>Mobilisation</td><td>53.47±11.45</td><td>49.98±9.77</td><td>28.1</td><td>56</td></tr><tr><td>(Joshi et al., 2021)</td><td>45</td><td>Exercises</td><td>1) SMIT + IFT + Exercices<br>2) IFT + Exercices</td><td>38.20 ± 7.27</td><td>1) 34.93 ± 9.43<br>2) 42.47 ± 10.15</td><td>-</td><td>-</td></tr><tr><td>(Saracoglu et al., 2022)</td><td>69</td><td>Home exercice</td><td>1) JMT + HE<br>2) PNE + JMT + HE</td><td>40.25 ± 9.70</td><td>1) 41.38 ± 12.70<br>2) 39.67 ± 13.71</td><td>55</td><td>1) 53<br>2) 60</td></tr><tr><td>(Zangrando et al., 2017)</td><td>51</td><td>Traditional massage therapy</td><td>New Rehabilitative Massage Program</td><td>50.54±9.13</td><td>50.77±6.80</td><td>58.33</td><td>55.56</td></tr><tr><td>(Grande-Alonso et al., 2019)</td><td>50</td><td>PT</td><td>PT + OMPT</td><td>38.29 (13.10)</td><td>39.88 (13.20)</td><td>56</td><td>56</td></tr><tr><td>(Bicalho E et al., 2010)</td><td>40</td><td>Without intervention</td><td>HVLA</td><td>26.5 ± 8.27</td><td>29.5 ± 9.64</td><td>60</td><td>75</td></tr><tr><td>(Senna & Machaly, 2011)</td><td>60</td><td>Sham manipulation</td><td>HVLA:<br>1) Maintened<br>2) No maintened</td><td>42 ± 10</td><td>1) 41.6 ± 11<br>2) 40.2 ± 12</td><td>24.3</td><td>1) 24<br>2) 27</td></tr><tr><td>(Nambi et al., 2018)</td><td>330</td><td>LT + exercises</td><td>HVLA and:<br>1) LT + exercises<br>2) LT</td><td>21-60</td><td>1) 21-60<br>2) 21-60</td><td>CG 67 (60.9)</td><td>1) 62.7<br>2) 58.2</td></tr><tr><td>(Didehdar et al., 2020)</td><td>25</td><td>Without intervention</td><td>HVLA</td><td>37.2 ± 7.01</td><td>36 ± 8.61</td><td>46.7</td><td>40</td></tr><tr><td>(Fagundes Loss et al., 2020)</td><td>24</td><td>Sham manipulation</td><td>HVLA</td><td>43.9 ± 9.6</td><td>41.7 ± 12.8</td><td>50</td><td>50</td></tr><tr><td>(Sarker et al., 2019)</td><td>90</td><td>SE+EA</td><td>HVLA + EA</td><td>24.20±6.78</td><td>1) 25.10 ± 7.75<br>2) 24.93 ± 8.46</td><td>-</td><td>-</td></tr><tr><td>(Wang et al., 2019)</td><td>60</td><td>SET</td><td>LPT + SET</td><td>32.01 ± 4.59</td><td>30.45 ± 5.55</td><td>43.3</td><td>36.7</td></tr><tr><td>(Tamer et al., 2017)</td><td>39</td><td>OMT</td><td>vOMT</td><td>36 (29-47)</td><td>42 (34.2-51.5)</td><td>47.4</td><td>60</td></tr><tr><td>(Balthazard et al., 2012)</td><td>37</td><td>UT + AE</td><td>MT + AE</td><td>42.0 ± 12.0</td><td>44.0 ± 12.0</td><td>30</td><td>36</td></tr><tr><td>(Thomas et al., 2020)</td><td>162</td><td>LT</td><td>Spinal:<br>1) Manipulation<br>2) Mobilization</td><td>24.4 (5.9)</td><td>1) 26.8 (7.2)<br>2) 24.3 (5.3)</td><td>58</td><td>1) 59<br>2) 58</td></tr><tr><td>(Zafereo et al., 2018)</td><td>40</td><td>PT</td><td>RMT<br>+ PT</td><td>38.2 (13.1)</td><td>46.7 (14.1)</td><td>50</td><td>75</td></tr></tbody></table>
CG: Control Group; EG: Experimental Group; FR: Fascial Release; MFR: MyoFascial Release; CrT: Craniosacral Therapy; DI: Diaphragm Intervention; OMT: Osteopathic Manual Therapy; SNAG: Sustained Natural Apophyseal Glide; PT: PhysioTherapy; MET: Muscle EnergyTechnique; DSE: Dynamic Stabilization Exercise; TMSE: Thoracic Mobilisation and Strengthening Exercises; CT: Conventional therapy; LSE: Lumbar Stabilization Exercises; STM: Soft Tissue Mobilisation; SMIT: Sub-Occipital Muscle Inhibition Technique; IFT: Interferential Current Therapy; JMT: Joint Mobilisation Techniques; PNE: Pain Neuroscience Education; OMPT: Orthopedic Manual Physical Therapy; HVLA: High-Velocity Low-Amplitude; LT: Laser therapy; LPT: Lumbar Pulling Technique; OMT: Osteopathic Manual Therapy; vOMT: Visceral Osteopathic Manual Therapy; MT: Manual Therapy; UT: Ultrasound Therapy; AE: Active Exercises; SMT: Spinal Manual Therapy; CTM: connective tissue manipulation; SM: sham massage.
<table><thead><tr><th>Trials</th><th>1</th><th>2</th><th>3</th><th>4</th><th>5</th><th>6</th><th>7</th><th>8</th><th>9</th><th>10</th><th>11</th><th>Total</th></tr></thead><tbody><tr><td>(Didehdar et al., 2020)</td><td>0</td><td>1</td><td>0</td><td>0</td><td>0</td><td>0</td><td>0</td><td>0</td><td>0</td><td>1</td><td>1</td><td>3</td></tr><tr><td>(Tamer et al., 2017)</td><td>0</td><td>1</td><td>0</td><td>1</td><td>0</td><td>0</td><td>0</td><td>0</td><td>0</td><td>1</td><td>0</td><td>3</td></tr><tr><td>(Arguisuelas et al., 2019)</td><td>0</td><td>1</td><td>0</td><td>1</td><td>0</td><td>0</td><td>0</td><td>0</td><td>0</td><td>1</td><td>1</td><td>4</td></tr><tr><td>(Auger et al., 2021)</td><td>1</td><td>1</td><td>0</td><td>0</td><td>0</td><td>0</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>4</td></tr><tr><td>(Hussein et al., 2021)</td><td>1</td><td>1</td><td>0</td><td>1</td><td>0</td><td>0</td><td>0</td><td>0</td><td>0</td><td>1</td><td>1</td><td>4</td></tr><tr><td>(Grande-Alonso et al., 2019)</td><td>1</td><td>1</td><td>0</td><td>0</td><td>0</td><td>0</td><td>0</td><td>1</td><td>0</td><td>1</td><td>1</td><td>4</td></tr><tr><td>(Bicalho et al., 2010)</td><td>1</td><td>0</td><td>0</td><td>1</td><td>0</td><td>0</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>4</td></tr><tr><td>(Endamli et al., 2019)</td><td>0</td><td>1</td><td>0</td><td>1</td><td>0</td><td>0</td><td>0</td><td>1</td><td>0</td><td>1</td><td>1</td><td>5</td></tr><tr><td>(Ahmed et al., 2021)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>0</td><td>0</td><td>0</td><td>1</td><td>1</td><td>5</td></tr><tr><td>(Balthazard et al., 2012)</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>0</td><td>0</td><td>0</td><td>0</td><td>1</td><td>1</td><td>5</td></tr><tr><td>(Arguisuelas et al., 2017)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>0</td><td>1</td><td>0</td><td>1</td><td>1</td><td>6</td></tr><tr><td>(Divya et al., 2021)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>0</td><td>1</td><td>0</td><td>1</td><td>1</td><td>6</td></tr><tr><td>(Zangrando et al., 2017)</td><td>1</td><td>1</td><td>0</td><td>1</td><td>0</td><td>0</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>6</td></tr><tr><td>(Senna & Machaly, 2011)</td><td>1</td><td>1</td><td>0</td><td>1</td><td>0</td><td>0</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>6</td></tr><tr><td>(Castro-Sánchez et al., 2016)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>7</td></tr><tr><td>(Joshi et al., 2021)</td><td>1</td><td>1</td><td>0</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>7</td></tr><tr><td>(Saracoglu et al., 2022)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>7</td></tr><tr><td>(Nambi et al., 2018)</td><td>1</td><td>1</td><td>0</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>7</td></tr><tr><td>(Fagundes Loss et al., 2020)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>1</td><td>0</td><td>1</td><td>1</td><td>1</td><td>7</td></tr><tr><td>(Celenay et al., 2019)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>7</td></tr><tr><td>(Branchini et al., 2016)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>8</td></tr><tr><td>(Martí-Salvador et al., 2018)</td><td>0</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>8</td></tr><tr><td>(Sarker et al., 2019)</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>8</td></tr><tr><td>(Wang et al., 2019)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>8</td></tr><tr><td>(Thomas et al., 2020)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>8</td></tr><tr><td>(Zafereo et al., 2018)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>8</td></tr><tr><td>(Boff et al., 2020)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>9</td></tr><tr><td>(Hussien et al., 2017)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>9</td></tr><tr><td>(Yagci et al., 2020)</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>0</td><td>1</td><td>1</td><td>1</td><td>1</td><td>1</td><td>9</td></tr></tbody></table>

<table><thead><tr><th>1</th><th>2</th><th>3</th><th>4</th><th>5</th><th>6</th><th>7</th><th>8</th><th>9</th><th>10</th><th>11</th></tr><tr><th>Eligibility criteria</th><th>Random allocation</th><th>Concealed allocation</th><th>Baseline comparability</th><th>Blind subjects</th><th>Blind therapists</th><th>Blind assessors</th><th>Adequate follow-up</th><th>Intention-to-treat analysis</th><th>Between-group comparisons</th><th>Point estimates and variability</th></tr></thead></table>
<table><thead><tr><th>Core Areas</th><th>Domains</th><th>Parameters</th><th>Measurements Tools</th><th>Occurrence frequency</th></tr></thead><tbody><tr><td rowspan="12">Life impact</td><td rowspan="2">Cognitive functioning</td><td>Fear Avoidance Beliefs</td><td>Fear Avoidance Belief Questionnaire</td><td>4</td></tr><tr><td>Pain catastrophization</td><td>Pain Catastrophizing Scale</td><td>4</td></tr><tr><td rowspan="4">Health-related quality of life</td><td rowspan="4">Quality Of Life</td><td>12-Item Short Form Survey</td><td>2</td></tr><tr><td>36-Item Short Form Survey</td><td>5</td></tr><tr><td>Euroqol - 5 Dimensions - 3 Levels</td><td>1</td></tr><tr><td>Euroqol - 5 Dimensions - 5 Levels</td><td>1</td></tr><tr><td>Medication</td><td>Intake and Frequency of Medication</td><td>Data Repository</td><td>1</td></tr><tr><td>Pain behaviour</td><td>Fear of movement</td><td>Tampa Scale Kinesiophobia</td><td>4</td></tr><tr><td rowspan="3">Pain intensity</td><td rowspan="2">Level of pain</td><td>Numerical Pain Rating Scale</td><td>9</td></tr><tr><td>Visual Analog Scale</td><td>18</td></tr><tr><td>Pain sensitivity</td><td>Algometer</td><td>3</td></tr><tr><td>Pain interference</td><td>Temporal Summation Magnitude</td><td>Visual Analog Scale</td><td>1</td></tr><tr><td rowspan="4">Pain quality</td><td>Self-efficacy</td><td>Chronic Pain Self-Efficacy Scale</td><td>1</td></tr><tr><td rowspan="2">Sensorial and affective</td><td>Brief Pain Inventory</td><td>1</td></tr><tr><td>Short-Form Mcgill Pain Questionnaire</td><td>3</td></tr><tr><td>Two-Point Discrimination Test</td><td>Esthesiometer</td><td>1</td></tr><tr><td rowspan="5">Physical functioning</td><td rowspan="4">Functional disability</td><td>Örebro Musculoskeletal Pain Screening Questionnaire</td><td>1</td></tr><tr><td>Owestry Disability Index</td><td>17</td></tr><tr><td>Quebec Back Pain Questionnaire</td><td>1</td></tr><tr><td>Roland Morris Disability Questionnaire</td><td>9</td></tr><tr><td>Interoception</td><td>Multidimensional Assessment Of Interoceptive Awareness</td><td>1</td></tr><tr><td rowspan="3">Psychological functioning</td><td>Anxiety and Depression</td><td>Hospital Anxiety Depression Scale</td><td>2</td></tr><tr><td rowspan="2">Depression</td><td>Beck Depression Inventory</td><td>1</td></tr><tr><td>Patient Health Questionnaire-9</td><td>1</td></tr><tr><td rowspan="2">Satisfaction with treatment services</td><td>Global Rating of Change</td><td>Global Rating Of Change Questionnaire</td><td>2</td></tr><tr><td>Satisfaction with back care</td><td>Global Rating Of Change Scale</td><td>1</td></tr><tr><td>Temporal aspects</td><td>Frequency</td><td>Patient'S Global Assessment Of Outcomes</td><td>1</td></tr><tr><td rowspan="10">Pathophysiological manifestations</td><td rowspan="2">Body structures</td><td>Lumbar lordosis</td><td>Flexible Ruler</td><td>1</td></tr><tr><td>Maximum low back muscle strength</td><td>Taiwan Test</td><td>1</td></tr><tr><td rowspan="2">Muscle activity</td><td rowspan="2">Muscle activation flexion-extension</td><td>Electromyogram</td><td>2</td></tr><tr><td>Mcquade Test</td><td>1</td></tr><tr><td rowspan="2">Muscle endurance</td><td rowspan="2">Abdominal muscles</td><td>Shirado Test</td><td>1</td></tr><tr><td>Ito Test</td><td>1</td></tr><tr><td rowspan="4">Pain biomarkers</td><td rowspan="2">Trunk extensor muscles</td><td>Sorensen Test</td><td>1</td></tr><tr><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td>Diastolic blood pressure</td><td>Photoplethysmogram</td><td>1</td></tr><tr><td>Heart Rate Variability</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td rowspan="2">Hemodynamic measures</td><td>Hemoglobin oxygen</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td></td><td></td><td></td></tr></tbody></table>
<table><tr><td></td><td></td><td>saturation</td><td></td><td></td></tr><tr><td></td><td></td><td>Interstitial fluid<br>biochemical estimation</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td></td><td></td><td>Measure of brain<br>metabolites</td><td>N-Acetylaspartate, Choline, Creatinine<br>Levels</td><td>1</td></tr><tr><td></td><td></td><td>Systolic blood pressure</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td rowspan="2">Proprioception</td><td></td><td>Lumbar Repositioning<br>Error</td><td>Dynanometer</td><td>1</td></tr><tr><td></td><td>Bending angle</td><td>Inclinometer</td><td>1</td></tr><tr><td rowspan="7">Range of motion</td><td rowspan="5">Lumbar Flexion</td><td>Finger-To-Floor Test</td><td>2</td></tr><tr><td>Modified-modified Schober</td><td>2</td></tr><tr><td>Mowestry Disability Indexfied Schober</td><td>1</td></tr><tr><td>Mowestry Disability Indexfied-Mowestry<br>Disability Indexfied Schober</td><td>1</td></tr><tr><td>Sit And Reach Test</td><td>1</td></tr><tr><td>Lumbar Flexion-<br>Extension</td><td>Behavioral Pain Scale</td><td>1</td></tr><tr><td>Lumbar Flexion-<br>Extension Lateral<br>Bending</td><td>Motion-Analysis System</td><td>1</td></tr><tr><td rowspan="5">Spinal control</td><td>Lumbar lateral bending</td><td>Lateral Bending Test</td><td>1</td></tr><tr><td>Hip and knee flexion</td><td>Pressure Biofeedback</td><td>1</td></tr><tr><td rowspan="2">Postural sway</td><td>Force Platform</td><td>2</td></tr><tr><td>Motion-Analysis System</td><td>1</td></tr><tr><td>Precision</td><td>Y-Balance Test</td><td>1</td></tr></table>
<table><thead><tr><th>CoreAreas</th><th>Domains</th><th>Parameters</th><th>Measurements Tools</th><th>Occurrence frequency</th></tr></thead><tbody><tr><td rowspan="12">Life impact</td><td rowspan="2">Cognitive functioning</td><td>Fear Avoidance Beliefs</td><td>Fear Avoidance Belief Questionnaire</td><td>4</td></tr><tr><td>Pain catastrophization</td><td>Pain Catastrophizing Scale</td><td>3</td></tr><tr><td rowspan="5">Health-related quality of life</td><td rowspan="5">Quality Of Life</td><td>12-Item Short Form Survey</td><td>2</td></tr><tr><td>36-Item Short Form Survey</td><td>1</td></tr><tr><td>Euroqol - 5 Dimensions - 3 Levels</td><td>1</td></tr><tr><td>Euroqol - 5 Dimensions - 5 Levels</td><td>1</td></tr><tr><td>Healthy Days Measures</td><td>1</td></tr><tr><td>Medication</td><td>Intake and Frequency of Medication</td><td>Data Repository</td><td>1</td></tr><tr><td>Pain behaviour</td><td>Fear of movement</td><td>Tampa Scale Kinesiophobia</td><td>3</td></tr><tr><td rowspan="4">Pain intensity</td><td rowspan="2">Level of pain</td><td>Numerical Pain Rating Scale</td><td>7</td></tr><tr><td>Visual Analog Scale</td><td>11</td></tr><tr><td>Pain sensitivity</td><td>Algometer</td><td>3</td></tr><tr><td>Temporal Summation Magnitude</td><td>Visual Analog Scale</td><td>1</td></tr><tr><td>Pain interference</td><td>Self-efficacy</td><td>Chronic Pain Self-Efficacy Scale</td><td>1</td></tr><tr><td rowspan="2">Pain quality</td><td>Sensorial and affective</td><td>Short-Form Mcgill Pain Questionnaire</td><td>3</td></tr><tr><td>Two-Point Discrimination Test</td><td>Esthesiometer</td><td>1</td></tr><tr><td rowspan="6">Physical functioning</td><td rowspan="5">Functional disability</td><td>Örebro Musculoskeletal Pain Screening Questionnaire</td><td>1</td></tr><tr><td>Owestry Disability Index</td><td>9</td></tr><tr><td>Quebec Back Pain Questionnaire</td><td>1</td></tr><tr><td>Roland Morris Disability Questionnaire</td><td>8</td></tr><tr><td>Waddel Disability Index</td><td>1</td></tr><tr><td>Interoception</td><td>Multidimensional Assessment Of Interoceptive Awareness</td><td>1</td></tr><tr><td rowspan="2">Psychological functioning</td><td>Anxiety and Depression</td><td>Hospital Anxiety Depression Scale</td><td>1</td></tr><tr><td>Depression</td><td>Patient Health Questionnaire-9</td><td>1</td></tr><tr><td rowspan="2">Satisfaction with treatment services</td><td>Global Rating of Change</td><td>Global Rating Of Change Questionnaire</td><td>3</td></tr><tr><td>Satisfaction with back care</td><td>Patient'S Global Assessment Of Outcomes</td><td>1</td></tr><tr><td rowspan="4">Pathophysiological manifestations</td><td>Temporal aspects</td><td>Frequency</td><td>Data Repository</td><td>1</td></tr><tr><td>Muscle activity</td><td>Muscle activation flexion-extension</td><td>Electromyogram</td><td>1</td></tr><tr><td rowspan="2">Muscle endurance</td><td>Abdominal muscles</td><td>Mcquade Test</td><td>1</td></tr><tr><td>Trunk extensor muscles</td><td>Shirado Test</td><td>1</td></tr><tr><td></td><td></td><td>Ito Test</td><td>1</td></tr></tbody></table>
<table><tr><td></td><td></td><td>Sorensen Test</td><td>1</td></tr><tr><td rowspan="7">Pain biomarkers</td><td>Diastolic blood pressure</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td>Heart Rate Variability</td><td>Photoplethysmogram</td><td>1</td></tr><tr><td>Hemodynamic measures</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td>Hemoglobin oxygen saturation</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td>Interstitial fluid biochemical estimation</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td>Measure of brain metabolites</td><td>N-Acetylaspartate, Choline, Creatinine Levels</td><td>1</td></tr><tr><td>Systolic blood pressure</td><td>Electro Interstitial Scanner</td><td>1</td></tr><tr><td rowspan="5">Range of motion</td><td>Bending angle</td><td>Inclinometer</td><td>1</td></tr><tr><td rowspan="2">Lumbar Flexion</td><td>Finger-To-Floor Test</td><td>1</td></tr><tr><td>Modified-Modified Schober</td><td>2</td></tr><tr><td rowspan="2">Lumbar Flexion-Extension Lateral Bending</td><td>Behavioral Pain Scale</td><td>1</td></tr><tr><td>Motion-Analysis System</td><td>1</td></tr><tr><td rowspan="4">Spinal control</td><td>Lumbar lateral bending</td><td>Lateral Bending Test</td><td>1</td></tr><tr><td>Hip and knee flexion</td><td>Pressure Biofeedback</td><td>1</td></tr><tr><td rowspan="2">Postural sway</td><td>Force Platform</td><td>2</td></tr><tr><td>Motion-Analysis System</td><td>1</td></tr><tr><td>Precision</td><td></td><td>Y-Balance Test</td><td>1</td></tr></table>