Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 7:45 AM
Study NCT ID:
NCT06791434
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2024-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Benefits of Dry Needling for Low Back Pain When Combined with Regular Treatment
Sponsor:
Dr. Vishwanath Karad MIT World Peace University
Organization:
Study Overview
Official Title:
Investigating Dry Needling As an Add-on Therapy to Conventional Treatment for Myofascial Low Back Pain: a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DryNATiMP
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: