Low back pain Musculoskeletal Diseases
Conditions
Interventions
Participants will be randomly assigned to either the cognitive muscular therapy (CMT) group or the control group. Both groups will receive seven weekly sessions, and outcomes will be measured at basel
Sponsors
University of Salford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults presenting with LBP pain duration >3 months and considered at high risk of poor long-term outcome (identified with STarTBack 9item tool) 2. Currently scoring 4 or more on a numerical response scale for pain from 0-10 (0=no pain, 10=worst pain) 3. Ability to stand for 10 minutes and walk for 5 minutes (required to complete the intervention) 4. Speak and understand English sufficiently to read the information sheet and sign the consent form
Exclusion criteria
Exclusion criteria: 1. Diagnosis of inflammatory arthritis 2. LBP due to pregnancy and up to 12 months post-pregnancy 3. Previous spinal surgery such as discectomy, anterior cervical discectomy and fusion, disc replacement, laminectomy and scoliosis fixation 4. Diagnosis of degenerative neurological disorders (e.g. multiple sclerosis/Parkinson’s disease) 5. BMI of more than 33 (as increased subcutaneous fat prevents the collection of surface EMG signals) 6. Pending litigation related to an injury, for example, at work or whilst driving 7. Vulnerable patients, for example, those who lack the mental capacity to make decisions, have dementia or are nearing the end of life 8. Unable to cancel or postpone other treatment for the condition, for example, physiotherapy, chiropractic or osteopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 19/02/2025: As this is a feasibility study the primary outcome is related to establishing the feasibility of a future large-scale clinical trial using the following criteria: 1. Recruitment: Average number of participants per GP provider per 2 months: red2 2. Adherence: Number of participants attending >5 (of 7) clinical sessions: red80% 3. Trial retention: Participants providing 8-month outcome data: red80% 4. Signal of effectiveness: 90% one-sided confidence interval of Roland Morris containing a standardised effect size: red75%) Previous primary outcome measure: Pain is measured using the Numerical Rating Scale (NRS) at baseline, 14 weeks, and 8 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 19/02/2025: 1. Pain is measured using the Numerical Rating Scale (NRS) at baseline, 14 weeks, and 8 months 2. Disability is measured using the Roland Morris Disability Questionnaire at baseline, 14 weeks, and 8 months 3. Pain catastrophizing is measured using the Pain Catastrophizing Scale at baseline, 14 weeks, and 8 months 4. Pain self-efficacy is measured using the Pain Self-Efficacy Questionnaire at baseline, 14 weeks, and 8 months 5. Quality of life is measured using the EQ-5D-5L at baseline, 14 weeks, and 8 months 6. Health resource utilisation is measured using a custom questionnaire at baseline, 14 weeks, and 8 months 7. Work productivity is measured using the Work Productivity and Activity Impairment (WPAI) questionnaire at baseline, 14 weeks, and 8 months Previous secondary outcome measure: 1. Disability is measured using the Roland Morris Disability Questionnaire at baseline, 14 weeks, and 8 months 2. Pain catastrophizing is measured using the Pain Catastrophizing Scale at baseline, 14 weeks, and 8 months 3. Pain self-efficacy is measured using the Pain Self-Efficacy Questionnaire at baseline, 14 weeks, and 8 months 4. Quality of life is measured using the EQ-5D-5L at baseline, 14 weeks, and 8 months 5. Health resource utilisation is measured using a custom questionnaire at baseline, 14 weeks, and 8 months 6. Work productivity is measured using the Work Productivity and Activity Impairment (WPAI) questionnaire at baseline, 14 weeks, and 8 months | — |
Countries
England, United Kingdom
Outcome results
None listed