Implementation of the Specific Treatment Of Problems of the Spine (STOPS) Approach in Bangladesh: A Prospective Sequential Comparison
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Activity limitation
研究概览
简要总结
The goal of this implementation trial is to evaluate the clinical outcomes associated with usual physiotherapy care compared to individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach in patients with chronic low back pain (CLBP). The main questions it aims to answer are:
- Is the STOPS approach more effective than usual care physiotherapy among patients with CLBP?
- Is STOPS physiotherapy cost-effective compared to usual physiotherapy care for patients with CLBP.
- Does STOPS training improve the quality of care among Bangladeshi physiotherapists?
详细描述
The goal of this implementation trial is to evaluate the clinical outcomes associated with usual physiotherapy care compared to individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach in patients with chronic low back pain (CLBP). The main questions it aims to answer are:
- Is the STOPS approach more effective than usual care physiotherapy among patients with CLBP?
- Is STOPS physiotherapy cost-effective compared to usual physiotherapy care for patients with CLBP.
- Does STOPS training improve the quality of care among Bangladeshi physiotherapists?
In phase I, patients with CLBP will be treated with usual physiotherapy care. In phase II, Bangladeshi physiotherapists will be provided with a STOPS training program by the Australian developers of STOPS. In phase III, the trained Bangladeshi physiotherapists will treat patients using the STOPS approach.
Clinical patient outcomes will be evaluated in Phase 1 and Phase 3 (pre and post implementation).
Physiotherapists' self-confidence and implementation behaviour will be evaluated before and after STOPS training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to the trial hypothesis and knowledge of the fact that two treatment options are being compared.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physiotherapists:
- •Qualified physiotherapists and physiotherapy assistants in Bangladesh who are involved in low back pain management and working in either or both trial settings will provide the treatment in phases 1 and
- •To be eligible, physiotherapists and physiotherapy assistants must be willing to participate in all phases of the trial (Phases I, II, and III). They must have completed the organised STOPS training course led by the original Australian developers (Jon Ford and Andrew Hahne), where the assessment and treatment protocols will be taught in Phase II.
- •A primary complaint of either:
- •low back pain, defined as pain between the inferior costal margin and the inferior gluteal fold with or without referral into the leg(s)
- •referred leg pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, with or without back pain
- •Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury)
- •Aged between 18 and 65 (inclusive)
- •Fluency in English or Bengali sufficient to complete questionnaires and to enable understanding of the intervention
- •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
排除标准
- •Physiotherapist:
- •Not willing to participate in the study for all 3 phases.
- •Red flag pathologies such as active cancer under current treatment, risk of spinal fracture, signs of potential infection, and major systemic inflammatory disease.
- •Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging
- •Current pregnancy, or childbirth within the last 6 months, as this could impair the ability to undertake exercises, and could also cause back and leg symptoms that are not related to the subgroups under investigation
- •Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections
- •Any history of lumbar spine surgery, as there is already considerable research evaluating the efficacy of post-surgical rehabilitation programs
- •A pain intensity score of less than 2/10 on the numerical pain rating scale due to low severity.
- •Minimal activity limitation, evidenced by a baseline ability to perform ALL of (walk, sit, and stand for one hour or more and no sleep disturbance at night), as we wish to exclude people with low severity.
- •Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants.
- •Planned absence of more than one week during the treatment period (such as holidays).
研究组 & 干预措施
Usual physiotherapy care
One physiotherapy assessment, 10 x 45-minute sessions of usual care physiotherapy (over a 10-week period), plus 1 x 45-minute followup session of usual care physiotherapy after 6 months.
干预措施: Usual physiotherapy care (Other)
Individualized (STOPS) physiotherapy
One physiotherapy assessment, 10 x 45-minute sessions of individualised (STOPS) physiotherapy (weekly for 10 weeks), plus 1 x 45-minute followup session of individualised (STOPS) physiotherapy after 6 months.
干预措施: Individualized (STOPS) physiotherapy (Other)
结局指标
主要结局
Activity limitation
时间窗: Primary endpoint will be 26 weeks post-enrolment.
Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.
Back Pain Intensity
时间窗: Primary endpoint will be 26 weeks post-enrolment.
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Leg Pain Intensity
时间窗: Primary endpoint will be 26 weeks post-enrolment.
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
次要结局
- Work hours missed(5, 10, and 26-weeks post enrolment)
- Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)(5, 10, and 26-weeks post enrolment)
- Pain Self Efficacy(5, 10, and 26-weeks post enrolment)
- Qualitative interviews(10 weeks post-enrolment)
- Work productivity(5, 10, and 26-weeks post enrolment)
- Health-related quality of life (EQ-5D-5L)(5, 10, and 26-weeks post enrolment)
- Depression, Anxiety and Stress Scales - DASS-21(5, 10, and 26-weeks post enrolment)
- Adverse events(5, 10, and 26-weeks post enrolment)
- Activity limitation(5, 10 and 52-weeks post enrolment)
- Inflammatory symptoms(5, 10, and 26-weeks post enrolment)
- Healthcare utilization(5, 10, and 26-weeks post enrolment)
- Participant adherence with treatment(5, 10, and 26-weeks post enrolment)
- Satisfaction with treatment(5, 10, and 26-weeks post enrolment)
- Pain severity(5, 10, and 26-weeks post enrolment)
- Back Pain Intensity(5, 10 and 52-weeks post enrolment)
- Sleep quality(5, 10, and 26-weeks post enrolment)
- Central Sensitisation symptoms(5, 10, and 26-weeks post enrolment)
- Global rating of change(5, 10, and 26-weeks post enrolment)
- Pain interference(5, 10, and 26-weeks post enrolment)
- Leg Pain Intensity(5, 10 and 52-weeks post enrolment)
- Pain Catastrophizing(5, 10, and 26-weeks post enrolment)
- Treatment Credibility(5, 10, and 26-weeks post enrolment)
研究者
Mohammad Ali
PhD researcher
Uttara Adhunik Medical College