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

NCT07535853 | Not Yet Recruiting

• 1 other identifier: TOS-LASER-1996
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thoracic Outlet Syndrome

Keywords

LPLT

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Participants will receive active laser therapy plus a standard physical therapy program (exercises a

EXPERIMENTAL

Participants will receive active laser therapy plus a standard physical therapy program (exercises and ultrasound)

Device: Low level laser therapy; Device: Therapeutic Ultrasound; Behavioral: Physical Therapy Exercises

Control group have ultrasound and exercise and sham laser therapy

SHAM COMPARATOR

Device: Therapeutic Ultrasound; Behavioral: Physical Therapy Exercises; Device: Sham Laser Therapy

Interventions

Low level laser therapy DEVICE

"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."

Participants will receive active laser therapy plus a standard physical therapy program (exercises a

Therapeutic Ultrasound DEVICE

"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."

Control group have ultrasound and exercise and sham laser therapy; Participants will receive active laser therapy plus a standard physical therapy program (exercises a

Physical Therapy Exercises BEHAVIORAL

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.

Control group have ultrasound and exercise and sham laser therapy; Participants will receive active laser therapy plus a standard physical therapy program (exercises a

Sham Laser Therapy DEVICE

"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."

Control group have ultrasound and exercise and sham laser therapy

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Low-Level Light Therapy; Ultrasonic Therapy; Exercise Therapy

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Diathermy; Hyperthermia, Induced; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Faculty of Physical Therapy

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 17, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04