Chronic Low Back Pain
Conditions
Keywords
Non-specific chronic low back pain, Cognitive functional therapy, Exercise classes
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.
Interventions
BEHAVIORALIndividual Cognitive Functional Therapy
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.
BEHAVIORALGroup Exercise Classes
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.
Sponsors
Curtin University
KU Leuven
Mayo General Hospital, Ireland
Health Service Executive, Ireland
University of Limerick
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Socio-economic Conditions Index | Baseline | Measures socio-economic status |
| 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 |
| 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. |
| 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 |
| Numerical rating scale (NRS) | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | Measures pain intensity |
| 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. |
| Patient Satisfaction Questionnaire | At 8-14 weeks | Assesses patient satisfaction |
| Short-Form Orebro Musculoskeletal Screening Questionnaire (OMSQ) | Measured at baseline | Stratifies patients into low, medium or high risk of delayed pain recovery and chronicity. |
| Medication usage | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | To assess changes in levels of medication used. |
| 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. |
| Nordic Musculoskeletal Screening Questionnaire | Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months | Assesses areas of bodily pain |
Countries
Ireland
Outcome results
None listed