Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:28 PM
Study NCT ID:
NCT07414069
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Intensity Laser Therapy in Carpal Tunnel Syndrome: Clinical, Sonographic, and Electrophysiological Outcomes
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
Evaluation of the Clinical, Sonographic, and Electrophysiological Efficacy of High-Intensity Laser Therapy (HILT) in Carpal Tunnel Syndrome
Status:
RECRUITING
Status Verified Date:
2025-12
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:
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is characterized by pain, paresthesia, and functional impairment resulting from increased pressure within the carpal tunnel. Although conservative treatment approaches such as splinting and pharmacological therapy are commonly used, High-Intensity Laser Therapy (HILT) has emerged as a non-invasive modality with potential analgesic, anti-inflammatory, and biostimulatory effects. However, evidence regarding its efficacy remains limited, particularly from sham-controlled studies incorporating objective outcome measures. This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the clinical, sonographic, and electrophysiological effectiveness of HILT in patients with mild-to-moderate CTS. Eligible patients aged 18 to 65 years with electrophysiologically confirmed mild-to-moderate CTS will be randomized into two groups: a HILT group and a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Clinical outcomes will be assessed using Visual Analog Scale (VAS) scores for pain, Boston Carpal Tunnel Questionnaire (BCTQ) scores for symptom severity and functional status, and grip strength measurements. Objective evaluations will include median nerve sensory and motor nerve conduction studies and ultrasonographic measurement of the median nerve cross-sectional area at the proximal carpal tunnel level. Assessments will be performed at baseline and at 1 and 3 months after treatment. This study aims to provide robust and objective evidence regarding the therapeutic effectiveness of HILT in the conservative management of carpal tunnel syndrome.
Detailed Description:
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, characterized by the compression of the median nerve due to increased pressure within the carpal tunnel. While conservative management strategies such as splinting and physical therapy modalities are the standard approach, High-Intensity Laser Therapy (HILT) has recently emerged as a potent, non-invasive therapeutic option . Utilizing an Nd:YAG laser source, HILT penetrates deep tissues to induce photochemical and photothermal effects. It is hypothesized to promote tissue repair by increasing ATP synthesis at the mitochondrial level, regulating Na/K pump activity, and providing analgesia by suppressing inflammatory mediators .
Although HILT is used in clinical practice, there is a scarcity of sham-controlled, double-blind studies that comprehensively evaluate its efficacy using a combination of clinical, electrophysiological, and ultrasonographic (median nerve cross-sectional area) parameters .
Study Objective: The primary objective of this prospective, randomized, double-blind, sham-controlled trial is to provide evidence-based data on the efficacy of HILT regarding pain, hand function, grip strength, nerve conduction velocities, and median nerve morphology (ultrasonographic cross-sectional area) in patients with mild-to-moderate CTS.
Study Population and Design: Patients aged 18-65 years presenting to the Physical Therapy Clinic with clinically and electrophysiologically confirmed 80 patient hand mild-to-moderate CTS will be recruited.
Outcome Measures and Timeline: Assessments will be performed by independent blinded researchers at Baseline, Month 1, and Month 3 post-treatment.
* Clinical Assessment: Pain intensity (Visual Analog Scale - VAS), symptom severity and functional status (Boston Carpal Tunnel Questionnaire - BCTQ), gross grip strength (Hand Dynamometer), and pinch strength (Pinchmeter) .
* Ultrasonographic Assessment: Measurement of the median nerve Cross-Sectional Area (CSA) at the proximal carpal tunnel inlet.
* Electrophysiological Assessment: Sensory and motor nerve conduction studies of the median nerve (evaluating distal latency, conduction velocity, and amplitude).
This study aims to demonstrate the multifaceted contribution (clinical, anatomical, and physiological) of HILT to nerve recovery by reducing edema and inflammation in the pathophysiology of CTS.
Although HILT is used in clinical practice, there is a scarcity of sham-controlled, double-blind studies that comprehensively evaluate its efficacy using a combination of clinical, electrophysiological, and ultrasonographic (median nerve cross-sectional area) parameters .
Study Objective: The primary objective of this prospective, randomized, double-blind, sham-controlled trial is to provide evidence-based data on the efficacy of HILT regarding pain, hand function, grip strength, nerve conduction velocities, and median nerve morphology (ultrasonographic cross-sectional area) in patients with mild-to-moderate CTS.
Study Population and Design: Patients aged 18-65 years presenting to the Physical Therapy Clinic with clinically and electrophysiologically confirmed 80 patient hand mild-to-moderate CTS will be recruited.
Outcome Measures and Timeline: Assessments will be performed by independent blinded researchers at Baseline, Month 1, and Month 3 post-treatment.
* Clinical Assessment: Pain intensity (Visual Analog Scale - VAS), symptom severity and functional status (Boston Carpal Tunnel Questionnaire - BCTQ), gross grip strength (Hand Dynamometer), and pinch strength (Pinchmeter) .
* Ultrasonographic Assessment: Measurement of the median nerve Cross-Sectional Area (CSA) at the proximal carpal tunnel inlet.
* Electrophysiological Assessment: Sensory and motor nerve conduction studies of the median nerve (evaluating distal latency, conduction velocity, and amplitude).
This study aims to demonstrate the multifaceted contribution (clinical, anatomical, and physiological) of HILT to nerve recovery by reducing edema and inflammation in the pathophysiology of CTS.
Study Oversight
Has Oversight DMC:
None
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?: