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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Subject diagnosed with myofascial low back pain, characterized by the presence of trigger points and localized muscle pain/tenderness

• Subject experiencing myofascial pain symptoms (e.g., muscle pain, tenderness) for at least 3 months

• Subject has a baseline Numeric Pain Rating Scale (NPRS) score of 4 or higher

• Subject has stable medical condition that is not expected to significantly deteriorate during the study period in the opinion of the investigator

• Woman who is postmenopausal for 12 months or less before screening (unless permanently sterilized or using an IUD) must have a negative urine pregnancy test prior to the randomization visit

• Subject is willing to comply with all aspects of the study protocol, including attending scheduled appointments, completing study assessments and adhering to applicable restrictions

• Subject has provided informed consent to participate in the study

• No spine/lumbar surgery in the last 6 months

Locations
Other Locations
India
Sigma Spine and Pain Clinic
RECRUITING
Pune
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2025-08
Participants
Target number of participants: 140
Treatments
Active_comparator: Conventional Treatment (CT) Group
Also known as Control group. In this group, patients to follow prescribed pharmacotherapy (Fixed Dose Combination Etoshine MR tablets BID) daily for first 2 weeks and prescribed physiotherapy daily until Day 168.
Experimental: Conventional Treatment + Dry Needling (CT+DN) Group
Also known as Add-on group. In this group, in addition to the treatment prescribed for the CT group, patients to also receive 5 dry needling sessions scheduled on Day 0, 3, 7, 10, and 14.
Related Therapeutic Areas
Sponsors
Leads: Dr. Vishwanath Karad MIT World Peace University

This content was sourced from clinicaltrials.gov