在孟加拉国，使用脊柱问题特异性治疗（stop）方法对慢性腰痛实施个体化物理治疗：一项前瞻性序贯比较临床试验方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-21 DOI:10.1016/j.cct.2025.107960

Mohammad Ali , Jon J. Ford , Ahmed Hossain , Musa Sani Danazumi , Andrew J. Hahne

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引用次数: 0

摘要

背景：慢性腰痛（CLBP）是一个主要的全球健康问题，在低收入和中等收入国家（LMICs）负担特别高，部分原因是缺乏循证管理。脊柱问题的特殊治疗（stop）方法提供个性化的、基于生物心理社会的物理治疗，在澳大利亚被证明是有效的。本试验旨在评估与孟加拉国常规物理治疗护理相比，stop个体化物理治疗方法的实施、有效性和成本效益。方法：将在孟加拉国的两个中心对年龄在18-65 岁的符合条件的参与者进行一项三期前瞻性顺序比较试验，这些参与者正在接受CLBP物理治疗。第一阶段将评估常规物理治疗护理，第三阶段将根据stop方法评估个性化物理治疗。第二阶段包括在stop中培训物理治疗师和助手。第一阶段和第三阶段的患者将在10 周内接受10次物理治疗，并在6 个月时进行第11次强化治疗。主要结局是5、10、26和52 周时的活动限制（Oswestry残疾指数）和疼痛强度（背部和腿部疼痛的数值评定量表）。次要结局包括整体效应、患者满意度、工作干扰、社会心理风险因素、生活质量、心理健康、睡眠、灾难化和自我效能。定性访谈将探讨患者和治疗师的经验。结果：将对定量和定性数据进行分析，以评估实施可行性、成本效益和治疗结果。结论：在孟加拉国，使用STOPS方法进行个体化物理治疗可以改善CLBP的治疗结果。临床试验注册：NCT05880212。

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Implementing individualised physiotherapy using the Specific Treatment of Problems of the Spine (STOPS) approach for chronic low back pain in Bangladesh: Protocol for a prospective sequential comparison clinical trial

Background

Chronic low back pain (CLBP) is a major global health issue, with a particularly high burden in low- and middle-income countries (LMICs) due partly to inadequate evidence-based management. The Specific Treatment of Problems of the Spine (STOPS) approach offers individualised, biopsychosocial-based physiotherapy shown to be effective in Australia. This trial aims to evaluate the implementation, effectiveness, and cost-effectiveness of the STOPS approach to individualised physiotherapy compared to usual physiotherapy care in Bangladesh.

Methods

A three-phase prospective sequential comparison trial will be conducted with eligible participants aged 18–65 years presenting for physiotherapy with CLBP at two centres in Bangladesh. Phase 1 will evaluate the usual physiotherapy care, and Phase 3 will evaluate individualised physiotherapy according to the STOPS approach. Phase 2 involves training physiotherapists and assistants in STOPS. Patients in Phases 1 & 3 will undergo 10 sessions of physiotherapy over 10 weeks, with an 11th booster session at 6 months. Primary outcomes are activity limitation (Oswestry Disability Index) and pain intensity (Numerical Rating Scales for back and leg pain) at 5, 10, 26 and 52 weeks. Secondary outcomes include global effect, patient satisfaction, work interference, psychosocial risk factors, quality of life, mental health, sleep, catastrophizing and self-efficacy. Qualitative interviews will explore patient and therapist experiences.

Results

Quantitative and qualitative data will be analysed to assess implementation feasibility, cost-effectiveness, and treatment outcomes.

Conclusion

Individualised physiotherapy using the STOPS approach could improve treatment outcomes for CLBP in Bangladesh.

Clinical trial registration

NCT05880212

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.