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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fixed Dose Combination "Etoshine MR" tablets

Intervention Type DRUG

Composition per tablet: Etoricoxib 60 mg + Thiocolchicoside 4 mg

Physiotherapy

Intervention Type OTHER

Exercises

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.

Group Type EXPERIMENTAL

Fixed Dose Combination "Etoshine MR" tablets

Intervention Type DRUG

Composition per tablet: Etoricoxib 60 mg + Thiocolchicoside 4 mg

Dry needling

Intervention Type PROCEDURE

Thin needle insertion

Physiotherapy

Intervention Type OTHER

Exercises

Interventions

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Fixed Dose Combination "Etoshine MR" tablets

Composition per tablet: Etoricoxib 60 mg + Thiocolchicoside 4 mg

Intervention Type DRUG

Dry needling

Thin needle insertion

Intervention Type PROCEDURE

Physiotherapy

Exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No