drugset / Trial / NCT06791434

Assessing the Benefits of Dry Needling for Low Back Pain When Combined With Regular Treatment

NCT06791434

Phase 4 Completed 156 enrolled Dr. Vishwanath Karad MIT World Peace University
RandomizedParallel-groupOpen-labelTreatment

Summary

The proposed clinical study aims to evaluate the effectiveness and safety of adding Dry Needling (DN) to Conventional Treatment (CT) for patients with Myofascial Low Back Pain (MLBP). MLBP is a widespread musculoskeletal condition that causes localized pain, muscle tenderness, and functional limitations, significantly affecting the quality of life and productivity of those affected. Conventional Treatment for MLBP typically combines pharmacotherapy (e.g., NSAIDs, muscle relaxants) and physiotherapy. Dry Needling, an emerging treatment that targets myofascial trigger points with fine needles, has demonstrated promise in relieving pain and improving functional outcomes. However, no study has yet evaluated the combined effects of CT and DN. This randomized, open-label, controlled trial will involve 140 patients (70 per group) and compare the effects of CT alone versus CT combined with DN. The primary objective is to assess the change in pain intensity, while secondary objectives include improvements in pressure pain threshold, range of motion, disability, quality of life, sleep, anxiety, and depression scores. Safety will also be assessed based on adverse events and vital sign changes. The study will span 24 weeks, with 11 scheduled visits for each participant. Data analysis will be conducted to determine the added benefit of DN as an adjunctive therapy to CT, with the ultimate goal of improving treatment strategies and patient outcomes for MLBP.

Timeline

Start
2024-08-30
Primary completion
2025-08-26
Completion
2025-08-26

Drugs

EvaluationDrugModalityDoseRoute
Background Etoricoxib Small molecule 60 mg
Background Thiocolchicoside Small molecule 4 mg

Indications

No indication recorded.