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Not yet recruiting NCT07535853

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

No phase Interventional Thoracic Outlet Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low level laser therapy, Therapeutic Ultrasound, Physical Therapy Exercises, Sham Laser Therapy.
Who it may be relevant to
Registry conditions: Thoracic Outlet Syndrome. Basic parameters: 30 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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."

Primary outcome measures

  • Pressure Pain Threshold (PPT) [Time frame: Baseline and 2 months post-treatment.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07535853 · TOS-LASER-1996

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗