NCT07405008

Brief 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. 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 3, 2026

Last Update Submit

February 9, 2026

Conditions

Carpal Tunnel Syndrome (CTS) in Breast Cancer Patients

Keywords

LASER ACUPUNCTURE -CARPAL TUNNEL SYNDROME -AROMATASE INHIBITORS-BREAST CANCER PATIENT

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 weeks

Secondary Outcomes (2)

  • Boston Carpal Tunnel Questionnaire (BCTQ)

    8weeks

  • Hand-Held Dynamometer (HHD)

    8weeks

Study Arms (2)

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.

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.

Other: Traditional physical therapy

Interventions

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 .

LASER acupuncture technique plus traditional physical therapy
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 .

Traditional physical therapy program

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The subject selection will be according to the following criteria:
  • Patients' age will be ranged between 40-60 years old.
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Research Ethical Committee Faculty of Physical Therapy

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Ethical Committee Faculty of Physical Therapy - Cairo University

CONTACT

01151312322eth.com@pt.cu.edu.eg

Research Ethical Committee Faculty of Physical Therapy

CONTACT

01151312322eth.com@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy Specialist at Damanhur Medical National Institute, EL-Behira, Egypt

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 12, 2026

Study Start

March 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

EG(1)