Clinical trial NCT04940715: Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain
Official title: Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain: a Double-blinded, Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic low back pain
Pain processing
Manual Therapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment. Randomized, longitudinal, experimental, prospective, parallel and double-blind study with chronic low back pain adults.
Primary purpose: TREATMENT

Brief summary: Patients with chronic low back pain may have altered pain processing, making them vulnerable to pain or disability. It can be measured with test like pressure pain threshold, temporal summation or conditioned pain modulation. Manual therapy has shown improve this pain processing variables in other conditions (like knee osteoarthritis or lateral elbow pain), although the quality of the evidence is low in terms of temporal summation and controversial in terms of conditioned pain modulation. There are not studies that had investigated the impact of manual therapy techniques on pain processing in patients with chronic low back pain.

Detailed description: Study Aims:

Aim #1: The main objective of this study is to determine the efficacy of two manual therapy approaches (passive joint mobilization and mobilization with movement) on pain (measured with Visual Analogue Scale) and pain processing (measured with pressure pain threshold, temporal summation and conditioned pain modulation) in patients with chronic low back pain and see its results on short, medium and long term.

Aim #2: The secondary objective is to compare the effect of both manual therapy techniques with an inactive control group in terms of pain and pain processing.

Aim #3: Determine the efficacy of manual therapy on intervention groups on psychological outcomes as catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale of Kinesiophobia) and depression (Beck Depressive Inventory) and compare them with control group.

Methodology Research Design: Randomized, longitudinal, experimental, prospective, parallel and double-blind study with patients with chronic low back pain.

Participants: Adults between 18-65 years old residing Comunidad de Madrid, all of whom were recruited personally for the study. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand.

Sample Size: The sample size will be calculated by means of the "Gpower 3.0.18" computer program.

Randomization: Randomization will be done through the GraphPad software (GraphPad Software, Inc CA 92037 USA). Patients who meet the inclusion criteria and have none of the exclusion criteria will be entered into the study and the sample will be randomized to obtain three groups in opaque and sealed envelopes: A (passive joint mobilization), B (mobilization with movement) and C (control group).

Masking: The double-blind criteria are met, in which the subjects participating in the study will not know the group to which they were assigned, as well as the physiotherapist in charge of collecting the outcomes data.

Eligibility criteria: Inclusion Criteria:

* Non-specific chronic low back pain patients, without lower limb pain
* Pain lasting 6 months or more
* Pain measure of 2 or more on a 0 to 10 scale
* Age between 18-65 years old
* Haven't received physical therapy during last month

Exclusion Criteria:

* Radiculopathy
* Neurological signs, symptoms or deficit
* Rheumatic/autoimmune/systemic disease
* History of fracture, trauma or previous spinal surgery
* Pregnancy
* Disc herniation
* Neuropathic pain
* Active cancer
* Spondylolysis/Spondylolisthesis
* Cognitive impairment
* Long-term opioid intake

Primary outcomes:
measure: Pain
timeFrame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
measure: Pressure pain threshold
timeFrame: Time Frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
measure: Temporal summation
timeFrame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
measure: Conditioned pain modulation
timeFrame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
measure: Kinesiophobia
timeFrame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
measure: Depression
timeFrame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
measure: Central sensitization
timeFrame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
measure: Disability
timeFrame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos (Madrid)
name: Oliver Martínez Pozas, PhD candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Europea de Madrid (Madrid)
name: Eleuterio A. Sánchez Romero, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Rey Juan Carlos (Madrid)
name: Josué Fernández Carnero, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Castilla La-Mancha (Toledo)
name: Héctor Beltrán Alacreu, PhD
role: STUDY_DIRECTOR
References:
citation: den Bandt HL, Paulis WD, Beckwee D, Ickmans K, Nijs J, Voogt L. Pain Mechanisms in Low Back Pain: A Systematic Review With Meta-analysis of Mechanical Quantitative Sensory Testing Outcomes in People With Nonspecific Low Back Pain. J Orthop Sports Phys Ther. 2019 Oct;49(10):698-715. doi: 10.2519/jospt.2019.8876. Epub 2019 Aug 23.
citation: Neelapala YVR, Bhagat M, Frey-Law L. Conditioned Pain Modulation in Chronic Low Back Pain: A Systematic Review of Literature. Clin J Pain. 2020 Feb;36(2):135-141. doi: 10.1097/AJP.0000000000000778.
citation: McPhee ME, Vaegter HB, Graven-Nielsen T. Alterations in pronociceptive and antinociceptive mechanisms in patients with low back pain: a systematic review with meta-analysis. Pain. 2020 Mar;161(3):464-475. doi: 10.1097/j.pain.0000000000001737.
citation: Alkhawajah HA, Alshami AM. The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial. BMC Musculoskelet Disord. 2019 Oct 18;20(1):452. doi: 10.1186/s12891-019-2841-4.
citation: Lascurain-Aguirrebena I, Newham D, Critchley DJ. Mechanism of Action of Spinal Mobilizations: A Systematic Review. Spine (Phila Pa 1976). 2016 Jan;41(2):159-72. doi: 10.1097/BRS.0000000000001151.
citation: Aspinall SL, Jacques A, Leboeuf-Yde C, Etherington SJ, Walker BF. No difference in pressure pain threshold and temporal summation after lumbar spinal manipulation compared to sham: A randomised controlled trial in adults with low back pain. Musculoskelet Sci Pract. 2019 Oct;43:18-25. doi: 10.1016/j.msksp.2019.05.011. Epub 2019 May 31.
citation: Arribas-Romano A, Fernandez-Carnero J, Molina-Rueda F, Angulo-Diaz-Parreno S, Navarro-Santana MJ. Efficacy of Physical Therapy on Nociceptive Pain Processing Alterations in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2502-2517. doi: 10.1093/pm/pnz366.