The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether individual cognitive functional therapy (CFT), when compared to group exercise classes is effective in reducing pain and disability in patients with non-specific chronic low back pain.

Detailed Description
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A multi-centre randomised study with 6 month, 12 month and 36 month follow up will be used. Patient with non- specific chronic low back pain will be assessed for eligibility. The patients fitting the inclusion criteria will be randomised to receive either the individual CFT or the group classes consisting of education and exercise. Participants' pain, disability, socio-economic status, beliefs, fear, catastrophizing, self-efficacy, general health, stress levels, as well as number and cost of treatments will be evaluated using a range of outcome measures at the start and on completion of the treatment. Patients will receive another copy of the questionnaires in the post at 6 month, 12 months and 36 months after treatment to reassess clinical outcomes. If a participant does not respond to follow-up, they will be telephoned to ask if they wish to complete the questionnaires.

Official Title
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The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Individual Cognitive Functional Therapy
* Behavioral: Group Exercise Classes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 75 Chronic low back pain greater than 6 months duration Score greater than 14% for disability on Oswestry Disability Index (ODI) Independently mobile (with or without aids), to be capable of participating in a rehabilitation programme Exclusion Criteria: Primary pain area is not the lumbar spine (from T12-buttocks) Leg pain as the primary problem (nerve root compression or disc prolapse with true radicular pain/radiculopathy, lateral recess/central or spinal stenosis with primary leg pain) <6 months post lumbar spine or lower limb or abdominal surgery Pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months Pregnancy Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, lupus, scheuermann's disease) Progressive neurological disease (e.g. multiple sclerosis (MS), parkinson's disease (PD), motor neuron disease (MND) Unstable cardiac conditions Red flag disorders like malignancy/cancer, acute traumas like fracture (<6 months ago) or infection, spinal cord compression/cauda equina

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual Cognitive Functional Therapy<br>The intervention being tested has four main components: (1) a cognitive component, for each patient, their vicious cycle of pain will outlined in a diagram based on their findings from the examination and the Orebro Musculoskeletal Pain Screening Questionnaire; (2) specific movement exercises designed to normalize maladaptive movement behaviours; (3) targeted functional integration of activities in their daily life previously, reported to be avoided or provocative by the patient; and (4) a physical activity and lifestyle programme. | Behavioral: Individual Cognitive Functional Therapy<br>* Cognitive functional therapy (CFT) is a novel, patient centred behavioural intervention which addresses multiple dimensions in non-specific chronic low back pain (NSCLBP). It combines a functional behavioural approach of normalising provocative postures and movements while discouraging pain behaviours, with cognitive restructuring of the NSCLBP problem.<br>|
| Active Comparator: Group Exercise Classes<br>6 classes will take place in total. The class has 3 components each week. First, a 30 minute talk and discussion on chronic pain, and some tips for participants. Second, a 40 minute exercise circuit, involving aerobic exercise, and gentle stretching and strengthening exercises. Finally, a 5 minute relaxation/mindfulness session will take place at the end. The total time involved is approximately 1 hour and 15 minutes. | Behavioral: Group Exercise Classes<br>* Each class involves a combination of education, exercise and relaxation/mindfulness. The education topics include pain and the nervous system, posture and ergonomics, exercise and relaxation and sleep. The exercise component includes 10 stations of a combination of aerobic, strength and flexibility exercises. These will be walking/jogging on the spot, mini-squats, sit to stands, wall push ups, bridging, step-ups and a combination of leg and low back stretches. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry Disability Index (ODI) | Used to assess change in disability levels over the course of the trial and follow-up | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) | Measures pain intensity | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| Socio-economic Conditions Index | Measures socio-economic status | Baseline | 
| Back Pain Beliefs Questionnaire | Assess a person's beliefs about their back pain | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ) | Assesses a person's level of fear-avoidance beliefs regarding physical activities. | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| The catastrophising subscale of the Coping Strategies Questionnaire (CSQ) | Assesses level of pain catastrophizing. | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| Pain Self- Efficacy Questionnaire (PSEQ) | Assesses level of pain self-efficacy | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| Subjective Health Complaints Inventory (SHC) | Assess level of subjective health complaints | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| Nordic Musculoskeletal Screening Questionnaire | Assesses areas of bodily pain | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| Stress subscale of the Depression, Anxiety and Stress scale (DASS 21) | Assesses patient's stress levels. | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| Patient Satisfaction Questionnaire | Assesses patient satisfaction | At 8-14 weeks | 
| Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ) | Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity. | Measured at baseline | 
| Medication usage | To assess changes in levels of medication used. | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | 
| Economic evaluation | Assesses direct and indirect costs of both treatment arms to see which is more cost-effective. | 6, 12 and 36 months | 
| Level of co-interventions | Assesses the number/type of healthcare services availed of throughout the intervention period. | Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-specific chronic low back pain, Cognitive functional therapy, Exercise classes