Thoracic Outlet SyndromeLPLT-TOSNCT07535853
Effect of Low-Power Laser Therapy on Pain and Functional Outcomes in Patients With Thoracic Outlet Syndrome
A study testing Low level laser therapy, Therapeutic Ultrasound and Physical Therapy Exercises in people with Thoracic Outlet Syndrome, run by Cairo University.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Low level laser therapy, Therapeutic Ultrasound and Physical Therapy Exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 17 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Low level laser therapy, Therapeutic Ultrasound, Physical Therapy Exercises, Sham Laser Therapy
- Keywords
- LPLT
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyDevice
"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."
Therapeutic UltrasoundDevice
"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."
Physical Therapy ExercisesBehavioural
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 Laser TherapyDevice
"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."
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Low level laser therapy; Device: Therapeutic Ultrasound; Behavioral: Physical Therapy Exercises |
| Control group have ultrasound and exercise and sham laser therapy | Sham comparator | Not described Receives: Device: Therapeutic Ultrasound; Behavioral: Physical Therapy Exercises; Device: Sham Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 2 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion17 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Tarek Sayed Zakaria, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535853
- Sponsor's protocol ID
- TOS-LASER-1996
- Acronym
- LPLT-TOS
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Power Laser Therapy on Pain and Functional Outcomes in Patients With Thoracic Outlet Syndrome
- ClinicalTrials.gov ID
- NCT07535853
- Acronym / sponsor ID
- LPLT-TOS / TOS-LASER-1996
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- LPLT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 17 Jul 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants will receive active laser therapy plus a standard physical therapy program (exercises a | Experimental | Device: Low level laser therapy, Device: Therapeutic Ultrasound, Behavioral: Physical Therapy ExercisesParticipants will receive active laser therapy plus a standard physical therapy program (exercises and ultrasound) |
| Control group have ultrasound and exercise and sham laser therapy | Sham comparator | Device: Therapeutic Ultrasound, Behavioral: Physical Therapy Exercises, Device: Sham Laser Therapy |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Participants will receive active laser therapy plus a standard physical therapy program (exercises a |
| 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." | Device | 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 ExercisesA 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. | Behavioural | 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"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." | Device | Control group have ultrasound and exercise and sham laser therapy |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy, Therapeutic Ultrasound and Physical Therapy Exercises in people with Thoracic Outlet Syndrome, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (PPT) (time frame: Baseline and 2 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.