NCT06791434

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

Investigating Dry Needling as an Add-on Therapy to Conventional Treatment for Myofascial Low Back Pain: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Dr. Vishwanath Karad MIT World Peace University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Fixed Dose Combination "Etoshine MR" tablets	Composition per tablet: Etoricoxib 60 mg + Thiocolchicoside 4 mg
PROCEDURE	Dry needling	Thin needle insertion
OTHER	Physiotherapy	Exercises

Timeline

• Start date: 2024-08-30
• Primary completion: 2025-08-26
• Completion: 2025-08-26
• First posted: 2025-01-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: India