- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07405008
Laser Acupuncture on Carpal Tunnel Syndrome .
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- 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
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
LASER Acupuncture technique:
|
|
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.
|
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
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
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
Sponsor
Investigators
- Principal Investigator: Research Ethical Committee Faculty of Physical Therapy, Cairo university
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1172027
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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