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

NCT06791434 | Completed Phase 4

• 1 other identifier: MITWPU-CS-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity using Numeric Pain Rating Scale (NPRS)

  Numeric Pain Rating Scale (NPRS) is a widely used, validated tool for assessing pain intensity. Patients are asked to rate their pain on a scale from 0 to 10, with 0 representing no pain and 10 representing the worst possible pain. This simple and reliable scale allows patients to quantify their pain level, aiding clinicians in monitoring pain over time and assessing the effectiveness of treatment interventions.

  Screening, Day 0, 3, 7, 10, 14, 28, 56, 84, 168

Secondary Outcomes (7)

• Change in Pressure Pain Threshold using Algometer

  Day 0, 3, 7, 10, 14, 28, 56, 84, 168

• Change in Range of Motion

  Day 0, 3, 7, 10, 14, 28, 56, 84, 168

• Change in Physical Disability using Salen's Disability Rating Index (DRI)

  Day 0, 7, 14, 28, 56, 84, 168

• Change in Pain and Sleep using Pain and Sleep Questionnaire (PSQ-3)

  Day 0, 7, 14, 28, 56, 84, 168

• Change in Quality of Life Scale Score using Burckhardt's Quality of Life Scale (QOLS)

  Day 0, 7, 14, 28, 56, 84, 168

Study Arms (2)

Conventional Treatment (CT) Group

ACTIVE COMPARATOR

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.

Drug: Fixed Dose Combination "Etoshine MR" tablets; Other: Physiotherapy

Conventional Treatment + Dry Needling (CT+DN) Group

EXPERIMENTAL

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.

Drug: Fixed Dose Combination "Etoshine MR" tablets; Procedure: Dry needling; Other: Physiotherapy

Interventions

Dry needling PROCEDURE

Thin needle insertion

Conventional Treatment + Dry Needling (CT+DN) Group

Fixed Dose Combination "Etoshine MR" tablets DRUG

Composition per tablet: Etoricoxib 60 mg + Thiocolchicoside 4 mg

Conventional Treatment (CT) Group; Conventional Treatment + Dry Needling (CT+DN) Group

Physiotherapy OTHER

Exercises

Conventional Treatment (CT) Group; Conventional Treatment + Dry Needling (CT+DN) Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subject presenting sharp, shooting pain radiating to lower limbs (associated with tingling and numbness) along with back pain
• Subject with active systemic or local infection(s)
• Subject with bleeding disorder(s) or on anticoagulant medication(s)
• Subject currently experiencing or with a history of psychiatric condition, cognitive impairment, neurological disorder, or other clinically significant disease or abnormality (such as congestive heart failure, uncontrolled hypertension, myocardial infarction, stroke, uncontrolled coronary artery disease, arrhythmias, uncontrolled diabetes, convulsive disorders etc.) which, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study, or would interfere with their ability to complete the study, or would hinder their ability to understand the study procedures, or would impact their compliance with study assessments or treatment protocols, or would affect pain perception
• Subject with a history of allergy or hypersensitivity to Etoricoxib, Thiocolchicoside or Diclofenac
• Subject with a history of alcohol or substance abuse
• Woman who is pregnant or planning pregnancy during the course of the study
• Subject who is currently participating in or has participated in any other clinical trial within 3 months prior to screening

Sponsors & Collaborators

• Dr. Vishwanath Karad MIT World Peace University: lead

Study Sites (1)

Sigma Spine and Pain Clinic

Pune, Maharashtra, 411045, India

Location

Related Publications (2)

• Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.

  PMID: 16945250 BACKGROUND

• Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.

  PMID: 20823359 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 24, 2025
• Study Start: August 30, 2024
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)