CompletedNot Applicable

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

Pakistan70 participantsStarted 2025-04-09

Plain-language 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.

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Intensity (Visual Analogue Scale, VAS)

Timeframe: Baseline, 3rd week, and 6th week

Functional Disability (Roland-Morris Disability Questionnaire, RMDQ)

Timeframe: Baseline, 3rd week, and 6th week

Kinesiophobia (Tampa Scale of Kinesiophobia, TSK)

Timeframe: Baseline, 3rd week, and 6th week

Trial details

NCT IDNCT07148635

SponsorUniversity of Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-11

View on ClinicalTrials.gov More Chronic Low Back Pain (CLBP) trials

Plain-language summary

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.