Carpal Tunnel Syndrome (CTS) in Breast Cancer PatientsNCT07405008
Laser Acupuncture on Carpal Tunnel Syndrome .
A study testing LASER acupuncture technique and Traditional physical therapy in people with Carpal Tunnel Syndrome (CTS) in Breast Cancer Patients, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS) in Breast Cancer Patients
- What is being tested?
- LASER acupuncture technique and Traditional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Ethical Committee Faculty of Physical Therapy - Cairo University contact
Egypt1 site
Faculty of Physical Therapy
Giza, 12613
Research Ethical Committee Faculty of Physical Therapy, 01151312322, eth.com@pt.cu.edu.eg
About this study
Official title: 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).
- -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.
- -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.
Read the 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).
- -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.
- -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:
- Measurement equipment:
- Nerve Conduction Studies (NCSs)
- Boston Carpal Tunnel Questionnaire (BCTQ)
- Hand-Held Dynamometer
- Therapeutic equipment:
- Laser Acupuncture technique for group (A).
- Traditional Physical therapy program for both groups.
- Being tested
- LASER acupuncture technique, Traditional physical therapy
- Keywords
- LASER ACUPUNCTURE -CARPAL TUNNEL SYNDROME -AROMATASE INHIBITORS-BREAST CANCER PATIENT
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASER acupuncture techniqueDevice
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 .
Traditional physical therapyOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| LASER acupuncture technique plus traditional physical therapy | Experimental | 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. Receives: Device: LASER acupuncture technique |
| Traditional physical therapy program | Experimental | 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. Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Motor Nerve Conduction Study
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.
Measured: 8weeks
Median Sensory Nerve Conduction Study:
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.
Measured: 8 weeks
Secondary outcomes (2)
Boston Carpal Tunnel Questionnaire (BCTQ)
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
Measured: 8weeks
Hand-Held Dynamometer (HHD)
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
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS) in Breast Cancer PatientsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naiera Sabry Mohamed Shams, Cairo University
- Investigators
- Research Ethical Committee Faculty of Physical Therapy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405008
- Sponsor's protocol ID
- 1172027
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 12 Feb 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Carpal Tunnel Syndrome Post Aromatase Inhibitors in Breast Cancer Patient .
- ClinicalTrials.gov ID
- NCT07405008
- Acronym / sponsor ID
- 1172027
- Keywords
- LASER ACUPUNCTURE -CARPAL TUNNEL SYNDROME -AROMATASE INHIBITORS-BREAST CANCER PATIENT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Feb 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 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).
- -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.
- -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.
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).
- -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.
- -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:
- Measurement equipment:
- Nerve Conduction Studies (NCSs)
- Boston Carpal Tunnel Questionnaire (BCTQ)
- Hand-Held Dynamometer
- Therapeutic equipment:
- Laser Acupuncture technique for group (A).
- Traditional Physical therapy program for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LASER acupuncture technique plus traditional physical therapy | Experimental | Device: LASER acupuncture techniqueGroup 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. |
| Traditional physical therapy program | Experimental | Other: Traditional physical therapyGroup (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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subject selection will be according to the following criteria:
Key exclusion criteria (6 listed)
- The potential participants will be excluded if they met one of the following criteria:
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 |
|---|---|---|
| LASER acupuncture techniqueLASER 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 . | Device | LASER acupuncture technique plus traditional physical therapy |
| Traditional physical therapyActive 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 . | Other | Traditional physical therapy program |
Primary outcome
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.
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.
2 secondary outcomes
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: 8weeks
Hand-Held Dynamometer (HHD)
Time frame: 8weeks
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 12 Feb 2026.
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.
Research Ethical Committee Faculty of Physical Therapy - Cairo University contact
Research Ethical Committee Faculty of Physical Therapy principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LASER acupuncture technique and Traditional physical therapy in people with Carpal Tunnel Syndrome (CTS) in Breast Cancer Patients, run by Cairo University at 1 site in Egypt.
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 6 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Research Ethical Committee Faculty of Physical Therapy - Cairo University (01151312322, eth.com@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Motor Nerve Conduction Study (time frame: 8weeks). The study lists 2 primary outcomes in all. 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 12 Feb 2026.