Electrical Dry Needling Versus Sham Dry Needling in Patients With Chronic Low Back Pain

NCT07148635 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-08-29

No results posted yet for this study

Summary

This study will evaluate the effectiveness of electrical dry needling (EDN) compared to sham dry needling (SDN) in patients with chronic low back pain (CLBP). CLBP is a common musculoskeletal condition associated with persistent pain, functional limitations, and reduced quality of life. Myofascial trigger points (MTrPs) are often implicated in CLBP and represent a key therapeutic target.

Dry needling is a minimally invasive procedure where fine needles are inserted into trigger points to release muscle tension and alleviate pain. Electrical dry needling is an advanced variation that applies low-frequency electrical stimulation through the inserted needles, potentially enhancing therapeutic effects. However, evidence is limited regarding its superiority over sham procedures.

In this randomized controlled trial, 70 adult participants with CLBP persisting for at least three months will be randomly assigned to one of two groups:

Group A (EDN + Conventional Therapy): Patients will receive electrical dry needling at active MTrPs combined with a structured physiotherapy program.

Group B (SDN + Conventional Therapy): Patients will receive sham dry needling at the same anatomical sites (using superficial or blunt needle placement without penetration) alongside the same physiotherapy program.

Interventions will be delivered weekly for six weeks. Assessments will occur at baseline, third week, and sixth week.

Primary outcomes include:

Pain intensity (Visual Analogue Scale, VAS)

Functional disability (Roland-Morris Disability Questionnaire, RMDQ)

Kinesiophobia (Tampa Scale of Kinesiophobia, TSK)

This trial is designed to clarify the clinical value of EDN beyond placebo effects, providing evidence to guide management of CLBP.

Conditions

  • Chronic Low Back Pain (CLBP)

Interventions

PROCEDURE

Electrical Dry Needling (EDN)

Electrical dry needling will be performed at active myofascial trigger points in lumbar muscles (quadratus lumborum, multifidus, iliocostalis lumborum). Fine monofilament needles are inserted into trigger points and connected to a low-frequency stimulator (2-10 Hz) for 10-15 minutes per session. Treatment is delivered once weekly for six weeks by a trained physiotherapist. Participants will also receive standardized conventional physiotherapy including core strengthening, stretching, posture education, and a home-based exercise program.

PROCEDURE

Sham Dry Needling (SDN)

Sham dry needling will be administered at the same anatomical sites as the experimental group, using superficial or blunt needle placement without penetration into muscle tissue and without electrical stimulation. Sessions are delivered once weekly for six weeks by a trained physiotherapist. Participants will also receive the same standardized conventional physiotherapy including core strengthening, stretching, posture education, and a home-based exercise program to maintain consistency with the experimental arm.

Sponsors & Collaborators

  • University of Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2025-08-11
Completion
2025-08-21

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148635 on ClinicalTrials.gov