NCT07400562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 28, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

Carpal tunnel syndromeNeuropathyLow-level laser therapyMedian nerve mobilization

Outcome Measures

Primary Outcomes (1)

  • Change in Median Nerve Motor Distal Latency

    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.

    6 weeks

Secondary Outcomes (3)

  • 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

Study Arms (3)

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

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

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.

Other: Therapist-Supervised Median Nerve Neural Mobilization Exercises

Standard Care Control Group

EXPERIMENTAL

Control group

Other: Standard Postoperative Care

Interventions

Group A: GaAs diode laser, 904 nm, average power 20 mW, probe diameter 7 mm (spot size approximately 0.385 cm²), administered as 1.2 J per point at four standardized points (totaling 4.8 J per session); 60 seconds per point (totaling approximately 4 minutes per session). Over 18 sessions (3 per week for 6 weeks), the total energy administered per treatment cycle is 86.4 J. This methodology and point-based dosing method were chosen to align with prevalent CTS protocols utilizing identical device specifications and total-session dosage, while adhering to the required 904-nm dosing parameters

LLLT (GaAs 904-nm Laser) Group

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. They were directed to maintain the final posture for 20 seconds. Therapist-supervised median nerve mobilization was performed three sessions/week for 6 weeks; each session included three sets of 5 repetitions of the standardized sequence, with the end-position held for 20 seconds per repetition and \~10 seconds rest between repetitions (and \~60 seconds rest between sets). Total mobilization time was \~10-12 minutes per session, and all sessions were conducted under direct therapist supervision to ensure correct positioning and symptom monitoring

Median Nerve Mobilization Group

Group C patients served as the comparison (control) group.

Standard Care Control Group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, Giza Governorate, 00000, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

gallium arsenide

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was designed as a prospective, parallel-group, randomized controlled trial. Eligible participants who had undergone unilateral carpal tunnel release were randomly assigned to one of three intervention arms in a 1:1:1 allocation ratio. Group A received adjunct low-level laser therapy, Group B received median nerve mobilization exercises, and Group C received standard postoperative care without adjunctive therapy. Randomization was performed using a concealed allocation method. Outcomes were assessed at baseline and after 6 weeks of intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical Pharmacy

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 10, 2026

Study Start

January 4, 2023

Primary Completion

January 19, 2024

Study Completion

September 18, 2025

Last Updated

February 10, 2026

Record last verified: 2026-01

Locations