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Evaluation of the Effects of Laser Therapy on Ultrasonographic Parameters of the Median Nerve and Quality of Life in Patients with Carpal Tunnel Syndrome

Assessment of the efficacy of Laser Therapy on Ultrasonographic Parameters of the Median Nerve and Quality of Life in Patients with Carpal Tunnel Syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260128068687N1
Enrollment
56
Registered
2026-02-09
Start date
2026-03-05
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome (CTS). Carpal tunnel syndrome

Interventions

Intervention 1: The active laser therapy group will be treated using a low-level laser device, model MLS M6. This device simultaneously emits two wavelengths of 808 nm (continuous) and 905 nm (pulsed)

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 65 years Diagnosis of mild to moderate carpal tunnel syndrome based on clinical and electrodiagnostic criteria Presence of carpal tunnel syndrome symptoms for at least 4 weeks No history of similar physical therapies including laser therapy or therapeutic ultrasound during the past 2 to 3 months Provision of written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: History of carpal tunnel release surgery in the studied hand Diagnosis of severe carpal tunnel syndrome based on electrodiagnostic findings Presence of uncontrolled diabetes mellitus or peripheral neuropathy other than carpal tunnel syndrome Pregnancy or breastfeeding Presence of active skin disease or open wound at the treatment site Presence of systemic inflammatory or rheumatologic diseases affecting peripheral nerves History of trauma or fracture in the studied wrist Inability to understand or complete the study questionnaires Presence of uncontrolled thyroid disorders

Design outcomes

Primary

MeasureTime frame
Primary Outcome Variable:Change in the cross-sectional area (CSA) of the median nerve at the pisiform levelDescription:The primary outcome of this study is the change in the cross-sectional area (CSA) of the median nerve at the level of the pisiform bone, which is considered the main ultrasonographic indicator of median nerve swelling in patients with mild to moderate carpal tunnel syndrome.The CSA of the median nerve will be measured using high-resolution ultrasonography performed by a trained physician following a standardized protocol, with the wrist positioned in a neutral posture. The CSA will be calculated by direct tracing of the nerve boundary on the ultrasound image and recorded in square millimeters (mm²). Each measurement will be performed three times, and the mean value will be used for analysis. Timepoint: Outcome measures will be assessed at two time points: at baseline (pre-intervention) and four weeks after completion of the treatment. Method of measurement: The cross-sectional area (CSA) of the median nerve is measured using high-resolution ultrasonography by direct tracing of the nerve boundary at the pisiform level and recorded in square millimeters (mm²).

Secondary

MeasureTime frame
Secondary Outcome Variable:Pain intensity assessed by the Visual Analog Scale (VAS)Description:Pain intensity is assessed as a secondary outcome using the Visual Analog Scale (VAS) in patients with carpal tunnel syndrome. The VAS consists of a 10-centimeter horizontal line anchored by “no pain” at one end and “worst imaginable pain” at the other. Patients indicate their perceived pain intensity by marking a point on the line, which is recorded as a numerical value ranging from 0 to 10. Changes in VAS scores before and after the intervention, as well as comparisons between the laser therapy and sham groups, are used to evaluate the effect of the intervention. Timepoint: The measurement time points for primary and secondary outcomes include baseline (before the intervention) and 4 weeks after the completion of the treatment course (post-intervention). Method of measurement: Secondary outcome variables include patients' quality of life assessed by the SF-36 questionnaire, as well as changes in functional status and symptom severity measured by the Boston CTS Questionnaire (BCTQ), and pain intensity assessed by the Visual Analog Scale (VAS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPegah Amirinezhad

Ahvaz University of Medical Sciences

amirinezhad.p@ajums.ac.ir+98 38 3333 8713

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026