- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07400562
Electrophysiological Effects of Adjunct Low-Level Laser Therapy and Median Nerve Mobilization After Carpal Tunnel Release (LL-CTR)
Electrophysiological Effects of Adjunct Low-Level Laser Therapy and Median Nerve Mobilization After Carpal Tunnel Release: A Randomized Controlled Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza Governorate
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Giza, Giza Governorate, Egypt, 00000
- Faculty of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LLLT (GaAs 904-nm Laser) Group
- 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
|
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
|
|
Experimental: Median Nerve Mobilization 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.
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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
|
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Experimental: Standard Care Control Group
Control group
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Group C patients served as the comparison (control) group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Median Nerve Motor Distal Latency
Time Frame: 6 weeks
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Median Nerve Sensory Distal Latency
Time Frame: 6 weeks
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Change in sensory distal latency (milliseconds) of the median nerve from baseline to 6 weeks post-intervention.
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6 weeks
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Change in Median Nerve Motor Conduction Velocity
Time Frame: 6 weeks
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Change in motor nerve conduction velocity (meters/second) of the median nerve from baseline to 6 weeks post-intervention.
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6 weeks
|
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Change in Compound Motor Action Potential Amplitude
Time Frame: 6 weeks
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Change in CMAP amplitude (millivolts) of the median nerve from baseline to 6 weeks post-intervention.
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6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Low-Level Laser Therapy -LLCTR
- Galala University (Other Identifier: i am faculty of pharmacy galala university-This study was approved by the Ethical Committee of the Faculty of physical)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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