NCT05880212

Implementation of the Specific Treatment of Problems of the Spine Approach in Bangladesh

Implementation of the Specific Treatment of Problems of the Spine (STOPS) Approach in Bangladesh: a Prospective Sequential Comparison

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Mohammad Ali · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

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. A qualitative study of physiotherapists' and patients' experiences will be conducted after the completion of the usual care (Phase I) and STOPS treatment programs (Phase III).

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
OTHER	Usual physiotherapy care	In Phase 1, physiotherapists will provide treatment for participants with chronic low back pain in accordance with their current standard physiotherapy practice. Physiotherapists will be free to choose the treatment approach they wish to.
OTHER	Individualized (STOPS) physiotherapy	In Phase 3, participants will receive individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach modified for chronic low back pain. Treatment will be individualized 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 individualized education/advice, exercise, manual therapy, activity modification/facilitation, goal setting, motor control optimisation, cognitive-behavioural strategies, inflammation management, pain management strategies, sleep management, work management, and relaxation approaches.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2023-05-30
• Last updated: 2024-12-04

Locations

1 site across 1 country: Bangladesh