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Clinical Trials/NCT07400562
NCT07400562
Completed
Not Applicable

Electrophysiological Effects of Adjunct Low-Level Laser Therapy and Median Nerve Mobilization After Carpal Tunnel Release: A Randomized Controlled Study

Galala University1 site in 1 country45 target enrollmentStarted: January 4, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Galala University
Enrollment
45
Locations
1
Primary Endpoint
Change in Median Nerve Motor Distal Latency

Overview

Brief Summary

This randomized controlled study investigated whether adding low-level laser therapy (LLLT) or median nerve mobilization after unilateral carpal tunnel release improves median nerve electrophysiological parameters compared with no adjunctive treatment. Forty-five patients were randomly assigned to receive LLLT, median nerve mobilization, or standard postoperative care. Interventions were delivered over six weeks, and nerve conduction studies were conducted before and after treatment to assess electrophysiological outcomes, with motor distal latency designated as the primary outcome measure.

Detailed Description

Carpal tunnel syndrome (CTS) is commonly managed surgically through carpal tunnel release (CTR); however, postoperative recovery may be accompanied by persistent neural dysfunction and delayed nerve conduction improvement. Adjunct rehabilitation strategies, such as low-level laser therapy (LLLT) and median nerve mobilization, have been proposed to enhance neural recovery, yet their electrophysiological effects following CTR remain insufficiently established.

This randomized controlled study aimed to examine and compare the effects of adjunct LLLT and median nerve mobilization on median nerve electrophysiological parameters after unilateral CTR. Forty-five patients diagnosed with unilateral CTS and treated surgically with CTR were recruited. Participants (aged 25-55 years) were randomly allocated into three equal groups. Group A received adjunct gallium arsenide (GaAs) infrared LLLT, Group B underwent median nerve mobilization exercises, and Group C received standard postoperative care without adjunctive therapy.

Both intervention protocols were applied three times per week for six consecutive weeks. Electrophysiological assessments were conducted at baseline (pre-intervention) and after six weeks using standardized nerve conduction studies. Measured parameters included motor distal latency (MDL), sensory distal latency (SDL), motor nerve conduction velocity (MCV), and compound motor action potential amplitude (CMAP), with MDL predefined as the primary outcome measure.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age between 25 and 55 years Clinical diagnosis of unilateral carpal tunnel syndrome Underwent surgical carpal tunnel release (transverse carpal ligament release)

Exclusion Criteria

  • Rheumatoid arthritis Diabetes mellitus History of wrist fracture or other wrist joint trauma Current use of anti-inflammatory medications or other interfering medications Receipt of alternative treatments (e.g., acupuncture, physical therapy modalities) Use of wrist orthoses

Arms & Interventions

LLLT (GaAs 904-nm Laser) Group

Experimental

- Patients in group (A) had a regimen of infrared Gallium Arsenide low-level laser therapy (20 mW average power, 904 nm wavelength, laser probe diameter of 7 mm). The treatment was administered to the palmar region above the carpal tunnel and along the median nerve pathway, with a cumulative dosage of 4.8 J

Intervention: Gallium Arsenide (GaAs) 904-nm Low-Level Laser Device (Other)

Median Nerve Mobilization Group

Experimental

Patients in the group (B) were instructed to do a series of movements that included the median nerve: lateral rotation of the shoulders, depression, wrist extension, supination, shoulder abduction, elbow extension, and bending the neck laterally to the other side.

Intervention: Therapist-Supervised Median Nerve Neural Mobilization Exercises (Other)

Standard Care Control Group

Experimental

Control group

Intervention: Standard Postoperative Care (Other)

Outcomes

Primary Outcomes

Change in Median Nerve Motor Distal Latency

Time Frame: 6 weeks

Change in motor distal latency (milliseconds) of the median nerve from baseline (pre-treatment) to 6 weeks post-intervention, assessed using standardized nerve conduction testing (Neuropack) following American Association of Electrodiagnostic Medicine guidelines.

Secondary Outcomes

  • Change in Median Nerve Sensory Distal Latency(6 weeks)
  • Change in Median Nerve Motor Conduction Velocity(6 weeks)
  • Change in Compound Motor Action Potential Amplitude(6 weeks)

Investigators

Sponsor
Galala University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eman Hamed

Lecturer of Clinical Pharmacy

Galala University

Study Sites (1)

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