The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain
- Conditions
- Chronic Low Back Pain
- Registration Number
- NCT02145728
- Lead Sponsor
- University of Limerick
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Oswestry Disability Index (ODI) Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Used to assess change in disability levels over the course of the trial and follow-up
- Secondary Outcome Measures
Name Time Method Back Pain Beliefs Questionnaire Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Assess a person's beliefs about their back pain
Numerical rating scale (NRS) Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Measures pain intensity
Socio-economic Conditions Index Baseline Measures socio-economic status
Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ) Measured at baseline Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity.
Physical activity subscale of the Fear-Avoidance Beliefs Questionnaire (FABQ) Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Assesses a person's level of fear-avoidance beliefs regarding physical activities.
The catastrophising subscale of the Coping Strategies Questionnaire (CSQ) Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Assesses level of pain catastrophizing.
Nordic Musculoskeletal Screening Questionnaire Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Assesses areas of bodily pain
Stress subscale of the Depression, Anxiety and Stress scale (DASS 21) Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Assesses patient's stress levels.
Economic evaluation 6, 12 and 36 months Assesses direct and indirect costs of both treatment arms to see which is more cost-effective.
Level of co-interventions Baseline, post-intervention (at 8-14 weeks), 6, 12 and 36 months Assesses the number/type of healthcare services availed of throughout the intervention period.
Pain Self- Efficacy Questionnaire (PSEQ) Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Assesses level of pain self-efficacy
Subjective Health Complaints Inventory (SHC) Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months Assess level of subjective health complaints
Patient Satisfaction Questionnaire At 8-14 weeks Assesses patient satisfaction
Medication usage Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months To assess changes in levels of medication used.
Trial Locations
- Locations (3)
Ballina Primary Care Centre
🇮🇪Mayo, Connacht, Ireland
Claremorris Primary Care Centre
🇮🇪Mayo, Connacht, Ireland
Mayo General Hospital
🇮🇪Mayo, Connacht, Ireland
Ballina Primary Care Centre🇮🇪Mayo, Connacht, Ireland