Clinical trial NCT03972332: Pain Experience in Individuals With Chronic Low Back Pain
Official title: Pain Experience in Individuals With Chronic Low Back Pain: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Low Back Pain
Central Sensitisation
Hyperalgesia
Hypersensitivity
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Versus Arthritis
name: Nottingham Biomedical Research Centre
name: Muculoskeletal Association of Chartered Physiotherapists
First posted: 2019-06-03
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with a confirmed diagnosis of CLBP that have been assigned for participation to a self-management program at a clinical or community setting

Brief summary: Low back pain is a very common musculoskeletal condition that affects many people each year regardless of age, gender, and ethnicity. Most people get better however, some continue suffering from painful episodes despite treatment.

Self-management strategies for the management of chronic low back pain are very important to patients as they help them develop skills to manage their pain more effectively. However, self-management strategies are not always effective as expected. It is possible that the brain has become very sensitive to signals coming from peripheral parts of the body (e.g. low back) affecting the ability of patients to self-manage their condition.

The aim of this study is to establish whether central sensitisation (sensitivity of the brain to peripheral signals) predicts how effective self-management approaches will be.

On three different occasions, scheduled sessions will include a clinical assessment session and completion of a questionnaire booklet. The clinical assessment will measure three features of central sensitisation: 1) sensitivity to blunt pressure on the forearm, 2) changes in pain, felt during repeated light pricking of the forearm skin, and 3) reduction in pain that accompanies inflation of a blood pressure cuff on the opposite arm. Participant involvement at each session is expected to last for 70 minutes.

Individuals over 18, diagnosed with chronic low back pain and enlisted to follow a pain management program are eligible to participate. The clinical assessments, questionnaire completion and subsequent statistical analysis are expected to be completed within 18 months of study commencement.

Based on our findings, future research may use similar clinical assessment to identify people who might be helped to self-manage by using treatment that reduces central sensitisation.

Detailed description: Low Back Pain (LBP) is considered a common condition consisting of a set of complains (pain, muscle tension, or stiffness), manifesting primarily to the lower back region (below the costal margin and above the inferior gluteal folds). LBP may or may not include radiating pain to the lower limb and can be caused by a number of underlying pathologies with varying levels of severity \[1\]. The condition can be the result of complex interactions between multiple physical and psychological factors including osteoarthritis (OA), degenerated discs, disc herniation, muscle dysfunction, obesity, poor posture, mental illness, negative affect (stress, anxiety, depression) \[2\].

LBP lifespan incidence appears to be 58-84% while it is estimated that 11% of males and 16% of females suffer from chronic LBP at any point in time \[3\]. It is expected that 40-50% of individuals suffering from acute LBP will continue to experience pain at three months and will demonstrate little or none further improvement, while 60-70% of those who improve will relapse within a year \[4\]. The global prevalence of LBP demonstrates continuously growing trends with a 17.3% increase in the last 10 years \[5\].

Self-management (SM) support is a portfolio of techniques and tools to help patients choose healthy behaviours as well as a fundamental transformation of the patient-caregiver relationship into a collaborative partnership \[6\]. Self-management support has to incorporate in its approach elements that aim to increase patients' self-efficacy, develop problem-solving, decision-making and goal-setting skills as well as to promote partner-like behaviour between patients and health professionals \[7\]. SM interventions pose as ideal rehabilitation strategies for chronic low back pain (CLBP) as they aim to address biological (neurophysiological, deconditioning, lifestyle) and psychosocial (self-efficacy, maladaptive beliefs, anxiety/depression) factors that have been identified as risk factors for poor outcome \[8, 9\] and are negatively affected by central sensitisation (CS) \[10\]. SM interventions are designed to be cost-effective by reducing health care utilisation associated with LBP \[11\].

Self-management programs (SMP) for CLBP demonstrate only small to moderate effects for long-term improvements in pain and disability. Currently, it is not known what factors predict effective self-management. Evidence of CS varies between individuals with chronic pain, and may contribute to the relatively poor efficacy of SMPs.

CS is a marker of widespread and centrally augmented pain that refers to those neurophysiological processes that can occur throughout the central nervous system (CNS) distribution, leading to changes in the spinal cord as well as in the brain \[12\]. The presence of CS increases the complexity of the clinical picture \[13\] and negatively affects a range of outcomes (e.g. pain, disability, negative affect, quality of life) following treatment \[14\]. CS is not present within all patients with chronic pain \[15\] rendering identification of those patients and decision-making for the right management approach even harder \[16\]. Patients with potential development of CS should receive treatment that address the full biopsychosocial clinical spectrum consisting of cognitive behavioural therapy (CBT) as well as therapeutic pain neuroscience education \[17\]. Changes in pain mechanisms may explain the moderate levels of evidence for the effectiveness of self-management (SM) interventions in LBP populations \[7\] as CS has been shown to negatively affect the perception of back pain, pain-related disability and lead to poor physical and mental health-related quality of life as well as to greater levels of depression and anxiety \[10\].

Quantitative Sensory Testing (QST) is a reliable \[18\] and valid \[19\] method to assess for the presence of CS and demonstrates predictive capacity in relation to musculoskeletal (MSK) treatment outcomes \[20\]. The testing consists of pressure pain threshold (PPT), punctate thresholds, temperature sensitivity, temporal summation (TS) and conditioned pain modulation (CPM) used to quantify noxious or innocuous stimuli within healthy individuals and patients alike \[21\]. QST has been used, among others, as a screening and assessment tool for sensory abnormalities in patients with pain disorders \[21\], as well as to assist in the stratification of patients \[22\] and evaluate the clinical aspects of peripheral and CS \[23\].

The STarT Back screening tool \[24\] was developed for individuals of LBP with the aim to identify prognostic indicators that could potentially assist decision making concerning initial treatment options in primary care \[25\]. Start Back has been formally validated, displaying satisfactory reliability, and has demonstrated that a stratified management approach displays higher health gains for patients with LBP than a non-stratified one \[26\]. Nevertheless, the tool's predictive performance has not been examined when other biomarkers (CS) are included as prognostic indicators.

Findings from this research will have an impact on differential diagnosis of chronic pain and CS identification as potential prognostic indicators for self-management. The results will assist effective patient subgrouping (stratification) based on CS measurements, aid appropriate self-management approaches in CLBP and potentially other chronic musculoskeletal pain states.

Eligibility criteria: Inclusion Criteria:

* have the ability to give informed consent.
* be 18 years old or over
* be diagnosed with chronic LBP
* be enlisted for participation in a self-management program
* be able to speak and understand English as all questionnaires are validated in the English language.

Exclusion Criteria:

* Inability to give informed consent due to cognitive impairment or otherwise
* Inability to understand key aspects of the study due to cognitive impairment or otherwise
* Patients giving history of additional co-morbidities such as cancer, diabetic neuropathies, fractures or other conditions causing greater disability than their back pain.
* Pregnancy

Primary outcomes:
measure: Self-management
timeFrame: 3 months
Secondary outcomes:
measure: Pain Severity: Numerical Rating Scale (NRS)
timeFrame: 3 months
measure: Levels of Disability
timeFrame: 3 months
measure: Patient Quality of Life: EQ-5D-5L questionnaire
timeFrame: 3 months
measure: Self-efficacy: Pain Self-efficacy Questionnaire (PSEQ)
timeFrame: 3 months
measure: Fatigue
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Catastrophization
timeFrame: 3 months
measure: Kinesiophobia
timeFrame: 3 months
measure: Neuropathic Pain: Pain-DETECT questionnaire (PD-Q)
timeFrame: 3 months
measure: Widespread Pain
timeFrame: 3 months
measure: Fibromyalgia Severity
timeFrame: 3 months
measure: Health care utilisation
timeFrame: 3 months
measure: Medication type utilisation
timeFrame: 3 months
Other outcomes:
measure: Course of low back pain: Keele Stratification and Screening Tool for Low Back Pain (STarT-Back)
timeFrame: 3 months
Locations:
city: Sutton In Ashfield
country: United Kingdom
facility: King's Mill Hospital
state: Nittinghamshire
Study officials:
affiliation: The University of Nottingham
name: David A. Walsh
role: PRINCIPAL_INVESTIGATOR
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