Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system
Conditions
Interventions
Intervention1: Individualised Physiotherapy based on the Specific Treatment Of Problems of the Spine (STOPS) approach: Description: Participants will receive individualised physiotherapy in accordance
Sponsors
Dr Kavitha Raja
Dr Andrew Hahne
Dr Jon Ford
Eligibility
Inclusion criteria
Inclusion criteria: 1. A primary complaint of either: a. low back pain, defined as pain between the inferior costal margin and the inferior gluteal fold with or without referral into the leg(s), or b. referred leg pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, with or without back pain (disc herniation with associated radiculopathy subgroup only) 2. Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury) 3. Aged between 18 and 65 (inclusive) 4. Fluency in English, Kannada or Hindi languages sufficient to complete questionnaires and to enable understanding of the intervention 5. Agreeing to refrain from other interventions wherever possible for the 10-week treatment period of the trial, aside from consultations with medical practitioners, medication, and any exercises already being undertaken.
Exclusion criteria
Exclusion criteria: 1. Active cancer under current treatment 2. Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging 3. Current pregnancy, or childbirth within the last 6 months 4. Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections 5. Any history of lumbar spine surgery 6. A pain intensity score of less than 2/10 on a 0-10 numerical rating scale due to low severity 7. Minimal activity limitation, evidenced by a baseline ability to walk, sit, and stand for one hour or more and no sleep disturbance at night, as we wish to exclude people with low severity 8. Already received more than 5 sessions of physiotherapy with any of the treating physiotherapists before enrolment, as these therapists are likely to use many components of the trial treatment protocol on their usual client caseload 9. Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants 10. Planned absence of more than one week during the treatment period (such as overseas holidays)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Oswestry Disability Index V2.1 with “sex life ? question replaced by a “work/housework ? question Timepoint: 0, 5, 10, 26 and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 6. Interference with work or housework in the past week (5- point Likert scale) and the number of hours missed at work in past week. 7. Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF) 8. Quality of life (EuroQol-5D-5L) 9. Pain Catastrophizing Scale (PCS) 10. Depression Anxiety and Stress Scale (DASS-21) 11. Pain Self-Efficacy questionnaire (PSEQ) 12. Pain Catastrophizing Scale (PCS) 13. Insomnia Severity Index (ISI) 14. Central Sensitisation Inventory (CSI) 15. Clinical inflammation score 16. Brief pain inventoryTimepoint: At baseline, 5th, 10th, and 26th week;1. Global rating of change scale (7-point Likert scale) 2. Satisfaction with treatment (5-point Likert scale) 3. Treatment Credibility Questionnaire 4. Healthcare utilisation 5. Adverse eventsTimepoint: 5th, 10th and 26th weeks;17. Compliance with treatmentTimepoint: 5th, 10th, 26th and 52nd weeks;18. Resting state and task based functional MRI (only from a cohort of the sample)Timepoint: Baseline and 11th week;19. Qualitative interviewsTimepoint: At the end of treatment trial (10th week);20. Treatment effect modifiers and mediators. The following potential treatment effect modifiers are identified a-priori: a) Pain type (nociceptive, neuropathic or nociplastic) b) Disability (Oswestry) c) Prognosis (Orebro) d) Duration of pain The following potential mediators identified a-priori: 1) Does self-efficacy mediate the effect of individualized physiotherapy on disability (Oswestry)? 2) Does inflammation (clinical signs of inflammation scale) mediate the effect of individualized physiotherapy on pain severity (NDI) and disability (Oswestry). Subsequently, a data-driven approach will be employed to identify other mediators and effect modifiers in an exploratory analysis.Timepoint: 10th week and 26th week;21. Average back pain intensity over the last week, measured on the 0-10 numerical pain rating scale 22. Average leg pain intensity over the last week, measured on the | — |
Countries
India
Contacts
Public ContactDr Kavitha Raja
JSS College of Physiotehrapy
Outcome results
None listed