Musculoskeletal Diseases
Conditions
Interventions
Phase 1 Usual physiotherapy care
Phase 3 Individualised physiotherapy according to the STOPS approach modified for persistent LBP
Sponsors
Federal Medical Centre Nguru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants with low back pain presenting to the Federal Medical Centre in Nigeria for treatment during Phase 1 or Phase 3 of the trial will be approached for consent if they meet the following 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 low back pain/leg pain lasting for greater than 3 months 3. Aged between 18 and 65 (inclusive) 4. Fluency in English sufficient to complete questionnaires and to enable understanding of the intervention (English is the primary language in Nigeria) 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: The exclusion criteria will be: 1. Active cancer under current treatment, as the treatment of cancer may interfere with their ability to participate in the trial 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, as this could impair the ability to undertake exercises 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, as there is already considerable research evaluating the efficacy of post-surgical rehabilitation programs 6. A pain intensity score of less than 2/10 on the BPI 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. Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants 9. Planned absence of more than one week during the treatment period (such as overseas holidays)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient outcomes 1) Average back pain intensity over the last week, measured on the 0-10 numerical rating scale, 2) Average leg pain intensity over the last week, measured on the 0-10 numerical rating scale 3) Activity limitation Oswestry Disability Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient outcomes 1) Work / housework interference - 0-10 point rating of interference with work productivity, and number of work hours missed in the previous week. 2) The Depression Anxiety & Stress Scales - DASS21 3) The Pain Self Efficacy Questionnaire (PSEQ) 4) The Pain Catastrophising Scale (PCS) 5) The Short Form Örebro Musculoskeletal Screening Questionnaire 6) The Insomnia Severity Index - ISI 7) Central sensitisation inventory CSI-9, measuring central sensitization symptoms 8) Clinical inflammation score to measure signs and symptoms of inflammation 9) EuroQoL-5D-5L for measuring the quality of life 10) Participant Diary to track healthcare, medication, and radiological imaging utilisation 11) Satisfaction with treatment measured on a 5-point Likert Scale 12) Treatment Credibility Questionnaire to determine the acceptability of the treatment approach 13) Participant adherence with treatment will be determined via the number of sessions attended, as well as a self-administered 0-10 rating scale at each follow-up 14) Global rating of change will be measured on a 7-point scale ranging from “very much worse” to “very much better” 15) Qualitative interviews: A qualitative study of patients experiences will be nested within the usual care and STOPS physiotherapy phases using semi-structured interviews. 16) Adverse events 17) Brief Pain Inventory Pain severity and pain interference scores ;Physiotherapist outcomes 1. Self-confidence in low back pain management measured using the Practitioner Self-Confidence Scale, 2. Determinants of implementation behaviour questionnaire DIBQ-t, 3. Assessment of treatment methods used vi a survey and clinical notes, 4. Qualitative semi-structured interviews of physiotherapists experiences with applying usual care and STOPS physiotherapy in Phases 1 and 3. ;Treatment effect modifiers The following potential treatment effect modifiers have been identified a-priori to be evaluated: a) Pain type (nociceptive, ne | — |
Countries
Nigeria
Contacts
Public ContactMusa Sani Danazumi
Physiotherapists at FMC Nguru and La Trobe University PhD student
Outcome results
None listed