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NCT Number: NCT07148635

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

About this study

Chronic low back pain (CLBP) affects approximately 7-8% of the global population and remains a leading cause of disability and healthcare burden. Conventional management strategies, including medication, manual therapy, and exercise, often provide partial or temporary relief. Myofascial trigger points (MTrPs) are highly prevalent in CLBP and contribute to persistent pain and movement restrictions.

Dry needling has emerged as a widely used intervention to deactivate MTrPs. The technique produces a local twitch response, improves blood flow, and reduces muscle tightness. Electrical dry needling (EDN) enhances this effect by delivering low-frequency electrical stimulation through the inserted needles, which may result in improved neuromuscular relaxation and pain modulation.

Despite encouraging findings from prior studies, the literature lacks rigorous trials comparing EDN with sham dry needling (SDN) controls. Sham procedures are critical to distinguish specific treatment effects from placebo or expectancy effects. This study aims to fill that gap.

Study Design:

Randomized controlled trial (parallel groups, single-blind).

Sample size: 70 patients (35 per group), aged 18-25 years, with CLBP >3 months and confirmed active MTrPs.

Recruitment site: Social Security Hospital, Kot Lakhpat, Lahore.

Duration: 9 months after approval.

Randomization: Lottery method.

Blinding: Single-blind (assessor unaware of treatment allocation).

Interventions:

Group A (EDN + Conventional Therapy): Weekly 30-45 min sessions for 6 weeks. EDN applied at quadratus lumborum, multifidus, and iliocostalis lumborum trigger points, with low-frequency electrical stimulation (2-10 Hz, 10-15 minutes). Physiotherapy includes core strengthening, stretching, posture education, and home-based exercises.

Group B (SDN + Conventional Therapy): Same physiotherapy protocol. Sham needling applied with superficial or blunt needles without tissue penetration; no electrical stimulation.

Outcome Measures:

Pain intensity (VAS)

Functional disability (Roland-Morris Disability Questionnaire)

Kinesiophobia (Tampa Scale of Kinesiophobia)

Data Collection: Baseline, 3rd week, and 6th week.

Statistical Analysis: Data will be analyzed using SPSS v24. Descriptive statistics will summarize demographics. Normality will be tested (Shapiro-Wilk/Kolmogorov-Smirnov). Between- and within-group comparisons will be conducted using ANOVA for parametric data, or Mann-Whitney/Wilcoxon tests for non-parametric data. Significance level set at p < 0.05.

Ethical Considerations:

The study has received Institutional Research Ethics Board (IREB) approval from the University of Lahore. Informed consent will be obtained from all participants. Confidentiality, anonymity, and voluntary participation will be ensured. Participants may withdraw at any time without penalty.

Potential Impact:

This study will provide high-quality evidence on the clinical effectiveness of EDN compared to SDN in CLBP patients. If successful, EDN may be integrated into physiotherapy practice as an evidence-based intervention for reducing pain, disability, and fear of movement in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Intensity (Visual Analogue Scale, VAS)

    Time frame: Baseline, 3rd week, and 6th week

    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.

  2. Functional Disability (Roland-Morris Disability Questionnaire, RMDQ)

    Time frame: Baseline, 3rd week, and 6th week

    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.

  3. Kinesiophobia (Tampa Scale of Kinesiophobia, TSK)

    Time frame: Baseline, 3rd week, and 6th week

    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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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