Laser Acupuncture on Carpal Tunnel Syndrome .

February 9, 2026 updated by: Naiera Sabry Mohamed Shams, Cairo University

Effect of Laser Acupuncture on Carpal Tunnel Syndrome Post Aromatase Inhibitors in Breast Cancer Patient .

The study will be carried out on a total number of fifty-four females with age ranged 40 - 60 years old suffering from CTS post mastectomy ,the patients will be randomly assigned into two groups equal in number (27 patients for each group from Damanhur Medical National institute).

  1. -Group (A): This group will include 27 patients will receive laser acupuncture technique 3 times per week in addition to traditional physical therapy program (myofascial release, nerve flossing ex., Tendon gliding ex. strengthening ex., ROM ex. and night splint) for 8 weeks.
  2. -Group (B): This group will include 27 patients will receive traditional physical therapy program (myofascial release, nerve flossing ex., Tendon gliding ex., strengthening ex., ROM ex. and night splint) for 8 weeks.

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.

Detailed Description

The study will be carried out on a total number of fifty-four females with age ranged 40 - 60 years old suffering from CTS post mastectomy , the patients will be randomly assigned into two groups equal in number (27 patients for each group from Damanhur Medical National institute).

  1. -Group (A): This group will include 27 patients will receive laser acupuncture technique 3 times per week in addition to traditional physical therapy program (myofascial release, nerve flossing ex., Tendon gliding ex. strengthening ex., ROM ex. and night splint) for 8 weeks.
  2. -Group (B): This group will include 27 patients will receive traditional physical therapy program (myofascial release, nerve flossing ex., Tendon gliding ex., strengthening ex., ROM ex. and night splint) for 8 weeks.

Equipment:

  1. Measurement equipment:

    1. Nerve Conduction Studies (NCSs)
    2. Boston Carpal Tunnel Questionnaire (BCTQ)
    3. Hand-Held Dynamometer

  2. Therapeutic equipment:

    1. Laser Acupuncture technique for group (A).
    2. Traditional Physical therapy program for both groups.

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.
54

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Research Ethical Committee Faculty of Physical Therapy
  • Phone Number: 01151312322
  • Email: eth.com@pt.cu.edu.eg

Study Contact Backup

  • Name: Research Ethical Committee Faculty of Physical Therapy - Cairo University
  • Phone Number: 01151312322
  • Email: eth.com@pt.cu.edu.eg

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Faculty of Physical Therapy
        • Contact:
          • Research Ethical Committee Faculty of Physical Therapy
          • Phone Number: 01151312322
          • Email: eth.com@pt.cu.edu.eg

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:

  • The subject selection will be according to the following criteria:

    • Patients' age will be ranged between 40-60 years old.
    • 54 Female patients had breast cancer will participate in this study.
    • All patients will have wrist pain and disability post AIS.
    • All patients will suffer from moderate to severe pain.
    • All patients will enroll to the study will have their informed consent

Exclusion Criteria:

  • The potential participants will be excluded if they met one of the following criteria:

    • Patients with previous history of fracture at the wrist fracture.
    • History of any arthritis related to wrist.
    • Rheumatoid arthritis wrist secondary to fracture, dislocation,
    • Reflex sympathetic dystrophy and neurological disorder, Malignancy.
    • Epilepsy or any psychological disorders.

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: Double

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: LASER acupuncture technique plus traditional physical therapy
Group A: 27 patients ,suffered from CTS post breast cancer treatment with Aromatase inhibitors, will receive Laser acupuncture technique in addition to traditional physical therapy program (myofascial release, nerve flossing ex., Tendon gliding ex. strengthening ex., ROM ex. and night splint)3 times per week for 8 weeks.
Device: LASER acupuncture technique

LASER Acupuncture technique:

  • Device: PR999, Medical Italia, Italy.
  • Maximum frequency: 5000 Hz
  • Dosage: 4j/point
  • Wave length :830 nm
  • Power output :50 m.W
  • Duration:12 min.
  • Frequency of treatment: 3 sessions/week.
  • Total treatment period: 8 weeks.
  • Total number of sessions: 24 sessions. The laser device will be positioned perpendicular to the skin over CTS area especially over each acupuncture point, for one minute duration for each point and the sessions will be conducted three times a week for eight weeks .
Experimental: Traditional physical therapy program
Group (B): 27 patients ,suffered from CTS post breast cancer treatment with Aromatase inhibitors , will receive traditional physical therapy program (myofascial release, nerve flossing ex., Tendon gliding ex., strengthening ex., ROM ex. and night splint) 3 times per week for 8 weeks.
Other: Traditional physical therapy
Active assisted ROM exercises. Each exercise was performed for all movements namely flexion, extension, ulnar & radial deviations, supination and pronation, one set of each 10-15 repetitions within pain-free range and instructed to carry out their ADLs, Patient education regarding work modification and ergonomic recommendations and Tendon gliding exercises. Each exercise begins with the wrist and fingers fully extended. During tendon-gliding exercises, the fingers were placed in five discrete positions: straight, hook, tabletop, full fist and straight fist .

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
Median Motor Nerve Conduction Study
Time Frame: 8weeks
With the help of electrode /conducting jelly, the recording was placed closed to motor of Abductor Policis Brevis and referance electrode 3 cm distal at the metacarpophalangeal joint. The ground electrode is placed between stimulation and recording electrode. A supramaximal stimulation was given at first to wrist and then at below. The difference between two latent period in msec gives the time taken by the impulses to travel from the elbow to the wrist.
8weeks
Median Sensory Nerve Conduction Study:
Time Frame: 8 weeks
The Orthodromic conduction recording was done in this case. Here the recording electrode was placed 3cm proximal to the distal wrist crease 3cm proximal to the recording electrode. The ring electrode were placed in the second and third digit and it was used for stimulation of the nerve with the cathode placed at the proximal inter phalangeal. The grounding electrode was placed between stimulating electrode and grounding electrode.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: 8weeks
The Boston Carpal Tunnel Questionnaire (BCTQ) is a widely recommended patient-reported outcome measure to evaluate symptoms and functions in carpal tunnel syndrome (CTS) patients. The BCTQ is a disease-specific PROM for CTS patients. It contains 2 measurement scales: a symptom severity scale (BCTQ-S) and a functional status scale (BCTQ-F). The BCTQ-S uses 11 questions to evaluate the intensity and frequency of pain, numbness, weakness and loss of dexterity on a five-point scale ranging from 1 (no symptoms) to 5 (severe symptoms). The results are interpreted as the average scores of the 11 questions. The BCTQ-F has 8 questions to evaluate the level of difficulty in performing daily tasks, each rated on a five-point scale ranging from 1 (no diffculty) to 5 (cannot do at all due to hand or wrist symptoms). The results are interpreted as the average scores of the 8 questions
8weeks
Hand-Held Dynamometer (HHD)
Time Frame: 8weeks
Hand-held dynamometers are portable devices usually incorporating a wireless load cell with an inbuilt microprocessor to measure isometric muscle force with good to excellent reliability across both clinical and healthy populations. These characteristics have made hand-held dynamometers a feasible and widely used tool to quantify muscle strength in a range of clinical populations. To assess hand grip, participants were seated comfortably in a chair with their feet supported. The hand and forearm being assessed was positioned with the shoulder adducted and in neutral rotation, with the elbow in 90◦ of flexion, forearm in neutral, and the wrist in 0 to 30◦ of extension and 0 to 15◦ of ulnar deviation. The participant was asked to grasp the hand-held dynamometer with the fingers wrapped around the handle. The clinical evaluator instructed the participant to perform a maximal contraction lasting three to five seconds, saying, "when I say go, I want you to squeeze the handle as hard as you
8weeks

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Research Ethical Committee Faculty of Physical Therapy, 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.
March 1, 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.
May 1, 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 1, 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).
February 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.
February 9, 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.
February 12, 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.
February 12, 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.
February 9, 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.
February 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.
  • 1172027

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.

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