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Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation (PM)

Primary Purpose

Post Mastectomy Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ga-As Laser
Microcurrent Electrical Stimulation
traditional therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Mastectomy Lymphedema focused on measuring post mastectomy, lymphedema, pain, Ga-As Laser, Microcurrent

Eligibility Criteria

40 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Catherine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Ga-As Laser

Microcurrent Electrical Stimulation

traditional therapy

Arm Description

the patients will receive Ga-As Laser and traditional therapy three times a week for three months

the patients will receive Microcurrent Electrical Stimulation and traditional therapy three times a week for three months

the patients will receive traditional therapy three times a week for three months

Outcomes

Primary Outcome Measures

pain intensity
pain intensity will be measured by visual analogue scale
Lymphedema volume
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)

Secondary Outcome Measures

Full Information

First Posted
May 12, 2023
Last Updated
October 22, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05870241
Brief Title
Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation
Acronym
PM
Official Title
Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
the aim of this study is to investigate the effect of GA-AS laser versus microcurrent on post-mastectomy shoulder pain and lymphedema.
Detailed Description
Breast cancer is extremely rare before the age of 25. It reaches a high incidence in the decade from 40 to 50 and continuous to increase in the frequency into old age. Mastectomy is the traditional approach to remove the entire breast once the diagnosis was confirmed. The most common cancers are lung cancer in men and breast cancer in women, however despite the large numbers of people affected by cancer there is very little literature on the role of physiotherapists in cancer care. After mastectomy and the accompanying excision or radiation of adjacent axillary lymph nodes a patient is at risk of developing upper extremity lymphedema, shoulder pain and loss of shoulder motion.low-level laser light waves penetrate deeply into the skin, they optimize the immune responses of our blood. This has both anti-inflammatory and immunosuppressive effects. It is a scientific fact that light transmitted to the blood in this way has positive effects throughout the whole body, supplying vital oxygen and energy to every cell .Electrical stimulation is based on the fact that human body has an endogenous bioelectric system that enhances healing of bone fracture, soft tissue lesions and decreasing post-operative pain. The external current may serve to mimic the failed natural bioelectric currents, so that post-operative pain can be inhibited. It was reported that microcurrent electrical neuromuscular stimulation (MENS) is better in enhancing cellular physiology processes than other current of higher amplitude, microcurrent is effective in the management of open wounds, inflammation and pain. sixty patients will be randomly allocated to three groups; first one will receive laser+ traditional therapy, second one will receive microcurrent + traditional therapy and third one will receive traditional therapy three times a week for three months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Mastectomy Lymphedema
Keywords
post mastectomy, lymphedema, pain, Ga-As Laser, Microcurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Ga-As Laser and Microcurrent
Masking
Outcomes Assessor
Masking Description
random generator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ga-As Laser
Arm Type
Experimental
Arm Description
the patients will receive Ga-As Laser and traditional therapy three times a week for three months
Arm Title
Microcurrent Electrical Stimulation
Arm Type
Experimental
Arm Description
the patients will receive Microcurrent Electrical Stimulation and traditional therapy three times a week for three months
Arm Title
traditional therapy
Arm Type
Active Comparator
Arm Description
the patients will receive traditional therapy three times a week for three months
Intervention Type
Other
Intervention Name(s)
Ga-As Laser
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Microcurrent Electrical Stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
pain intensity
Description
pain intensity will be measured by visual analogue scale
Time Frame
up to twelve weeks
Title
Lymphedema volume
Description
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)
Time Frame
up to twelve weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Catherine
City
Giza
ZIP/Postal Code
11251
Country
Egypt

12. IPD Sharing Statement

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Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation

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