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

NCT07148635 | Completed DMC

• 1 other identifier: UOL/IREB/25/09/0026
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Electrical Dry Needling; Myofascial Trigger Points; Myofascial Pain Syndrome; Kinesiophobia; Sham Dry Needling

Outcome Measures

Primary Outcomes (3)

• Pain Intensity (Visual Analogue Scale, VAS)

  Pain will be assessed using a 10-cm Visual Analogue Scale, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." This provides a validated, subjective measure of current pain intensity.

  Baseline, 3rd week, and 6th week

• Functional Disability (Roland-Morris Disability Questionnaire, RMDQ)

  Functional disability will be evaluated using the 24-item Roland-Morris Disability Questionnaire. Scores range from 0 to 24, with higher scores indicating greater disability and functional limitations due to low back pain.

  Baseline, 3rd week, and 6th week

• Kinesiophobia (Tampa Scale of Kinesiophobia, TSK)

  Fear of movement will be measured using the 17-item Tampa Scale of Kinesiophobia (TSK). Items are scored on a 4-point Likert scale (range 17-68), with higher scores indicating greater fear of movement and injury.

  Baseline, 3rd week, and 6th week

Study Arms (2)

Electrical Dry Needling with Conventional Therapy

EXPERIMENTAL

Participants will receive electrical dry needling (EDN) applied to active myofascial trigger points in lumbar muscles (quadratus lumborum, multifidus, iliocostalis lumborum) once weekly for six weeks. Fine monofilament needles will be inserted into trigger points and connected to a low-frequency electrical stimulator (2-10 Hz) for 10-15 minutes per session. In addition, participants will follow a standardized physiotherapy program including core strengthening, lumbar and hamstring stretching, posture education, and a home-based exercise plan.

Procedure: Electrical Dry Needling (EDN)

Sham Dry Needling with Conventional Therapy

PLACEBO COMPARATOR

Participants will receive sham dry needling (SDN) once weekly for six weeks. Needles will be applied superficially or with blunt instruments at the same anatomical points as the experimental arm, but without penetration into muscle tissue and without electrical stimulation. Alongside SDN, participants will receive the same standardized physiotherapy program as the experimental group, including core strengthening, stretching, posture education, and a home-based exercise plan.

Procedure: Sham Dry Needling (SDN)

Interventions

Electrical Dry Needling (EDN) PROCEDURE

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.

Electrical Dry Needling with Conventional Therapy

Sham Dry Needling (SDN) PROCEDURE

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.

Sham Dry Needling with Conventional Therapy

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both male and female gender will be included (Fernández-Carnero, 2021).
• Clinically diagnosed of chronic low back pain persisting for at least three months (Tüzün et al., 2017)
• Identifiable active myofascial trigger points in the lower back muscles, confirmed through palpation or another standardized method (Donohoe, 2016).
• Moderate to severe pain intensity, measured by a visual analog scale (VAS) (Tüzün et al., 2017)
• Sufficient cognitive and physical ability to engage in assessments and interventions (Tüzün et al., 2017)

You may not qualify if:

• Known hypersensitivity to needles, history of severe bleeding disorders, or any condition that contraindicates dry needling (Tüzün et al., 2017)
• Use of other physical therapy interventions or dry needling treatments in the last three months for low back pain (Fernández-Carnero, 2021).
• Presence of specific spinal conditions (e.g., disc herniation, spinal stenosis, fractures, or recent spinal surgeries) (Tüzün et al., 2017)
• History of neurological conditions affecting movement, sensation, or pain perception, such as multiple sclerosis or peripheral neuropathy (Donohoe, 2016)
• Pregnant women will be excluded due to potential risks associated with the interventions (Tüzün et al., 2017)
• Unstable psychiatric conditions or active substance abuse that could interfere with participation or adherence to study procedures

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

Related Publications (1)

• Tuzun EH, Gildir S, Angin E, Tecer BH, Dana KO, Malkoc M. Effectiveness of dry needling versus a classical physiotherapy program in patients with chronic low-back pain: a single-blind, randomized, controlled trial. J Phys Ther Sci. 2017 Sep;29(9):1502-1509. doi: 10.1589/jpts.29.1502. Epub 2017 Sep 15.

  PMID: 28931976 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes; Kinesiophobia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: August 29, 2025
• Study Start: April 9, 2025
• Primary Completion: August 11, 2025
• Study Completion: August 21, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)