Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT07148635
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrical Dry Needling Versus Sham Dry Needling in Patients With Chronic Low Back Pain
Sponsor:
University of Lahore
Organization:
Study Overview
Official Title:
Electrical Dry Needling Versus Sham Dry Needling in Patients With Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: