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Clinical outcomes, cost-effectiveness and implementation of individualised physiotherapy using the Specific Treatment Of Problems of the Spine (STOPS) approach for chronic low back pain in Nigeria: a protocol for a prospective sequential clinical trial

Por: Danazumi · M. S. · Ford · J. · Kaka · B. · Hahne · A.
Introduction

Despite advances in the physiotherapy management of low back pain (LBP) worldwide, studies indicate that there is a large variation in the quality of physiotherapy management for LBP in Nigeria. This clinical trial aims to evaluate the implementation of individualised physiotherapy for chronic LBP in Nigeria using the Specific Treatment Of Problems of the Spine (STOPS) approach.

Methods and analysis

This will be an implementation clinical trial using a non-randomised, prospective, sequential comparison design. One hundred and fifty-four participants with chronic LBP will be recruited at one hospital in Nigeria. In phase I, participants will receive 11 sessions of usual physiotherapy care. In phase II, consenting physiotherapists will undergo training in the implementation of the STOPS treatment approach, led by the original Australian developers. In phase III, participants will receive 11 sessions of individualised physiotherapy using the STOPS approach. Patient evaluation in phases I and III will be measured at baseline and at 5, 10, 26 and 52 weeks, and will evaluate the clinical outcomes (including primary outcomes of pain intensity measured with a 0–10 Numerical Rating Scale, and activity limitation measured via the Oswestry) and cost-effectiveness from the healthcare perspective (incremental healthcare costs relative to incremental quality adjusted life-years gained on the EuroQOL-5D-5L). Physiotherapist outcomes will include confidence in treating LBP and implementation behaviour measured at the start of phase I and at the end of phases I, II and III. Implementation feasibility and qualitative analysis of patient and physiotherapist experiences will also be explored.

Ethics and dissemination

The trial has been approved by the Human Research Ethics Committees of La Trobe University, Australia (HEC22278) and Federal Medical Centre (FMC) Nguru, Yobe State, Nigeria (FMC/N/CL.SERV/355/VOL IV/131). The study results will be shared through peer-reviewed journals and conferences.

Trial registration number

PACTR202305707317550.

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