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

April 10, 2026 updated by: Eman Tarek Sayed Zakaria, Cairo University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold (PPT)
Time Frame: Baseline and 2 months post-treatment.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings