- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05870241
Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation (PM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt, 11251
- Catherine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All patients will be female patient. Their ages will be ranged from 40 to 55 years old. All patients will have postmastectomy shoulder pain and lymphedema. All patients will be assessed carefully by the physician before the starting of the study procedures.
All patients will be conscious and ambulant. All patients will have surgical mastectomy on the right breast region (site of the surgical excision is right side).
The common indication of breast mastectomy for all cases will be pathological disorder of the breast (breast cancer).
All patients will receive the same necessary or required drugs and diet regime. All patients in the three groups of the study will receive the same medications (antibiotics and diuretics) (Akai
Exclusion Criteria:
Patients who have other pathological conditions or histories except postmastectomy shoulder pain and lymphedema.
Patients with evidence of local recurrence or distant metastasis will be excluded from the study.
Patient who takes other medications that may affects the results Patients who are not ambulant Patients who have surgical mastectomy on the left side breast region not the right one.
Patients who are not co-operative during assessment and treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ga-As Laser
the patients will receive Ga-As Laser and traditional therapy three times a week for three months
|
Patient sits on a chair with back support and the two GA-AS laser ( 5 milli Watts & 904 nm) probe will be applied one on the shoulder tip for 5 minutes and the other application another 5 minutes will be on the center of deltoid muscle.
The main power of the laser switch will be turned on.
The duration of the treatment will be 10 minutes.
the patients will receive traditional physical therapy in the form of manual lymphatic drainage , compression bandage, exercise to increase lymphatic drainage, skin care.
and ROM exercises to improve shoulder mobility
|
Experimental: Microcurrent Electrical Stimulation
the patients will receive Microcurrent Electrical Stimulation and traditional therapy three times a week for three months
|
the patients will receive traditional physical therapy in the form of manual lymphatic drainage , compression bandage, exercise to increase lymphatic drainage, skin care.
and ROM exercises to improve shoulder mobility
The patient sits on a chair with back support and the two electrodes from Microcurrent 850 unit device will be applied one on the shoulder tip and the other electrode on the center of the deltoid muscle.
A wet cloth was placed between the electrode and the patient's skin.
An adhesive tape was used to hold the electrode over the treated areas.
The main power switch will be turned on.
The treatment duration will be for 10 minutes.
|
Active Comparator: traditional therapy
the patients will receive traditional therapy three times a week for three months
|
the patients will receive traditional physical therapy in the form of manual lymphatic drainage , compression bandage, exercise to increase lymphatic drainage, skin care.
and ROM exercises to improve shoulder mobility
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
Time Frame: up to twelve weeks
|
pain intensity will be measured by visual analogue scale
|
up to twelve weeks
|
Lymphedema volume
Time Frame: up to twelve weeks
|
lymphedema volume will be measured by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone.
The volume of the segment was calculated as V=h(C12 +C1C2+C22 )/12π, where V is the volume of the segment, C1 and C2 are the circumferences at the ends of the segment, and h is the distance between them (segment length)
|
up to twelve weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003506
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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