Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305707317550 Date of Approval: 05/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implementation of the Specific Treatment Of Problems of the Spine (STOPS) approach in Nigeria for persistent low back pain: A prospective sequential comparison
Official scientific title Implementation of the Specific Treatment Of Problems of the Spine (STOPS) approach in Nigeria for persistent low back pain: A prospective sequential comparison
Brief summary describing the background and objectives of the trial The prevalence of low back pain (LBP) in Africa is high and Nigeria has been reported as having the highest prevalence rate. Despite advances in the physiotherapy management of LBP worldwide, previous studies showed that there is a large variation in the quality of physiotherapy management of LBP in Nigeria, which increases disability and reinforces the disparity in LBP care between Nigeria and developed nations. These findings indicate that the quality of physiotherapy care for LBP in Nigeria needs to be optimized. Aims and objectives The study aims to evaluate the implementation of the STOPS treatment approach for managing persistent low back pain in a hospital setting in Nigeria. The specific objectives of the study are: 1. To improve physiotherapists’ knowledge and skills in providing evidence-based treatment of persistent LBP in Nigeria. 2. To improve outcomes for patients with persistent LBP treated by physiotherapists in Nigeria. 3. To determine the cost-effectiveness of the STOPS treatment approach relative to usual care for managing persistent LBP in Nigeria. 4. To evaluate the effectiveness of the STOPS treatment approach in a different country to where it was developed. This will be a prospective, sequential comparison design, comprising three phases: 1. Phase 1: Evaluation of usual physiotherapy care in Nigeria. Physiotherapists’ evaluation (self-confidence, implementation behaviour and treatment methods employed), observation of usual clinical practice and clinical outcomes of participants recruited prospectively over a 6-month baseline period. 2. Phase 2: A quality improvement program comprising a STOPS training program led by the developers. 3. Phase 3: Evaluation of STOPS physiotherapy care in Nigeria post-implementation. Physiotherapists’ evaluation, observation of clinical practice and clinical outcomes of a new cohort of participants recruited over 6 months following therapist training and implementation of the STOPS treatment protocols
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 29/05/2023
Actual trial start date
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 154
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Phase 1 Usual physiotherapy care One physiotherapy assessment 10 x 45-minute sessions of usual physiotherapy care (weekly for 10 weeks) 1 x 45-minute followup session of usual physiotherapy care after 6 months. Participants will receive one physiotherapy assessment plus 10 x 45-minute sessions of usual physiotherapy care over a 10-week period, with an 11th session scheduled for 6 months post-study commencement to review progress. In Phase 1, physiotherapists will provide treatment for participants with low back pain in accordance with their current standard physiotherapy practice. Physiotherapists will be free to choose the treatment approach they wish to. 77 Active-Treatment of Control Group
Experimental Group Phase 3 Individualised physiotherapy according to the STOPS approach modified for persistent LBP One physiotherapy assessment 10 x 45-minute sessions of individaulised physiotherapy (weekly for 10 weeks) 1 x 45-minute followup session of individualised physiotherapy after 6 months. Participants will receive one physiotherapy assessment plus 10 x 45-minute sessions of individualised physiotherapy over a 10-week period, with an 11th session scheduled for 6 months post-study commencement to review progress. Participants will receive individualised physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach modified for persistent low back pain. Treatment will be individualised on the basis of biopsychosocial assessment findings including dominant pain type (nociceptive, neuropathic or nociplastic), pathoanatomical subgroups (if any), and other barriers to recovery (eg. inflammation, depression, anxiety, stress, catastrophising, pain self-efficacy, and unhelpful motor control strategies). Available treatment strategies will include individualised education/advice, exercise, manual therapy, activity modification/facilitation, goal setting, motor control optimisation, cognitive-behavioural strategies, inflammation management, pain management strategies, sleep management strategies, work management strategies, and relaxation approaches. 77
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/09/2021 Federal Medical Centre Nguru
Ethics Committee Address
Street address City Postal code Country
02 Machina Road, Nguru Nguru 630101 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/10/2022 La Trobe University Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kingsbury Drive Melbourne 3086 Australia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 Baseline, 5, 10, 26 and 52 weeks post-enrolment
Secondary Outcome 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 At baseline, and at 5, 10, and 26 weeks post-enrolment, or at the end of Phases 1 and 3 for qualitative interviews
Secondary Outcome 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. Phases 1, 2 and 3
Secondary Outcome Treatment effect modifiers The following potential treatment effect modifiers have been identified a-priori to be evaluated: a) Pain type (nociceptive, neuropathic or nociplastic) b) Disability (Oswestry) c) Prognosis (Orebro) d) Duration of pain Mediator analyses will determine potential mechanisms of action for the individualized physiotherapy, with the following potential mediators identified a-priori: 1) Does self-efficacy mediates the effect of individualized physiotherapy on pain interference (BPI) or disability (Oswestry)? 2) Does inflammation (clinical signs of inflammation scale) mediate the effect of individualized physiotherapy on pain severity and pain interference (BPI). Following testing of pre-planned modifier and mediation analyses, hypotheses, a data-driven approach will be employed to identify new hypotheses in an exploratory analysis. 10 weeks, 26 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Nguru 02 Machina Road, Nguru Nguru 630101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ford Family Trust Kingsbury Drive Melbourne 3086 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Federal Medical Centre Nguru 02 Machina Road Nguru Yobe State Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Professor Andrew Hahne La Trobe University Kingsbury Drive Melbourne 3086 Australia
Associate Professor Jon Ford La Trobe University Kingsbury Drive Melbourne 3086 Australia
Musa Sani Danazumi Federal Medical Centre 02 Machina Road Nguru Yobe State 630101 Nigeria
Jao M Kato Federal Medical Centre 02 Machina Road Nguru Yobe State 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Andrew Hahne a.hahne@latrobe.edu.au +61394793392 Kingsbury Drive
City Postal code Country Position/Affiliation
Melbourne 3086 Australia Professor of Physiotherapy at La Trobe University
Role Name Email Phone Street address
Public Enquiries Musa Sani Danazumi musadanazumisani@gmail.com 09028439699 02 Machina Road
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Physiotherapists at FMC Nguru and La Trobe University PhD student
Role Name Email Phone Street address
Scientific Enquiries Jon J. Ford j.ford@latrobe.edu.au +61394793392 Kingsbury Drive
City Postal code Country Position/Affiliation
Melbourne 3086 Australia Associate Professor at La Trobe University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual and de-identified participant data collected during the trial will be available upon request. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of the study completion date Other researchers wishing to access data from the trial can request access to the specific data elements they require for a specific project. The request can be made to the Principal Investigator or the La Trobe University Human Ethics Committee. Following the signing of a data sharing agreement between the parties outlining the nature and restrictions of the use of the data for the specific purpose, the required data will be released to the requesting researcher to a verified institutional email address via CloudStor where the requested data set will be stored. Only de-identified data will be shared.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information