Effect of Low-Power Laser Therapy on Pain and Functional Outcomes in Patients With Thoracic Outlet Syndrome (LPLT-TOS)

The purpose of this study is to evaluate the effect of low-power laser therapy on pain intensity and functional outcomes in patients diagnosed with Thoracic Outlet Syndrome (TOS). Participants will be randomly assigned to either receive the active laser therapy combined with a physical therapy program or a control group. The study aims to determine if adding laser therapy provides better relief and improves daily physical functions compared to conventional treatment alone.

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracic Outlet Syndrome
• Intervention / Treatment: Device: Low level laser therapy; Device: Therapeutic Ultrasound; Behavioral: Physical Therapy Exercises; Device: Sham Laser Therapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age

Inclusion Criteria:

• Age between 35-50 years.
• Clinically diagnosed with Thoracic Outlet Syndrome (TOS) by a physician based on standard diagnostic criteria.
• Presence of neurogenic symptoms such as pain, paraesthesia, numbness, or --
• weakness in the upper extremity.
• Symptoms lasting for at least 3 months.

Exclusion Criteria:

• History of cervical disc herniation or cervical radiculopathy.
• Previous surgical intervention in the cervical or thoracic outlet region.
• Severe cardiovascular or systemic diseases that may interfere with treatment. --Pacemakers or other implanted electronic devices.
• Skin conditions or infections in the treatment area.
• Receiving any other form of laser therapy or conflicting treatment during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants will receive active laser therapy plus a standard physical therapy program (exercises a; Participants will receive active laser therapy plus a standard physical therapy program (exercises and ultrasound)	Device: Low level laser therapy; "Patients will receive low-level laser therapy using a Gallium-Aluminum-Arsenide (GaAlAs) laser diode. Wavelength: 850nm, Power: 100mW. It will be applied to specific trigger points in the neck and shoulder area for 5 minutes per session, 3 times per week for 4 weeks."; Device: Therapeutic Ultrasound; "Pulsed therapeutic ultrasound applied to the symptomatic area. Frequency: 1 MHz, Intensity: 1.5 W/cm², Duty cycle: 20%. The treatment will be applied for 5-8 minutes per session."; Behavioral: Physical Therapy Exercises; A supervised physical therapy program focusing on stretching and strengthening exercises for the neck and shoulder girdle. This includes stretching of the scalene and pectoralis minor muscles, as well as strengthening of the middle and lower trapezius and serratus anterior. Each session lasts 30 minutes, twice per week for 8 weeks.
Sham Comparator: Control group have ultrasound and exercise and sham laser therapy	Device: Therapeutic Ultrasound; "Pulsed therapeutic ultrasound applied to the symptomatic area. Frequency: 1 MHz, Intensity: 1.5 W/cm², Duty cycle: 20%. The treatment will be applied for 5-8 minutes per session."; Behavioral: Physical Therapy Exercises; A supervised physical therapy program focusing on stretching and strengthening exercises for the neck and shoulder girdle. This includes stretching of the scalene and pectoralis minor muscles, as well as strengthening of the middle and lower trapezius and serratus anterior. Each session lasts 30 minutes, twice per week for 8 weeks.; Device: Sham Laser Therapy; "The same laser device will be used as in the experimental group, but without delivering any active laser energy. The device will be applied to the same points for the same duration to ensure blinding of the participants."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold (PPT)	The minimum pressure at which a stimulus is perceived as painful, measured using a digital pressure algometer at specific trigger points. The device measures the pressure in kilograms per square centimeter (kg/cm²).	Baseline and 2 months post-treatment.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 17, 2026

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: LPLT
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Thoracic Outlet Syndrome; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Diathermy; Hyperthermia, Induced; Laser Therapy; Phototherapy; Exercise Therapy; Low-Level Light Therapy; Ultrasonic Therapy
• Other Study ID Numbers: TOS-LASER-1996

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No