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

NCT05870241 | Completed

• 1 other identifier: P.T.REC/012/003506
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Mastectomy Lymphedema

Keywords

post mastectomy; lymphedema; pain; Ga-As Laser; Microcurrent

Outcome Measures

Primary Outcomes (2)

• pain intensity

  pain intensity will be measured by visual analogue scale

  up to twelve weeks

• 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)

  up to twelve weeks

Study Arms (3)

Ga-As Laser

EXPERIMENTAL

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

Other: Ga-As Laser; Other: traditional therapy

Microcurrent Electrical Stimulation

EXPERIMENTAL

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

Other: Microcurrent Electrical Stimulation; Other: traditional therapy

traditional therapy

ACTIVE COMPARATOR

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

Other: traditional therapy

Interventions

Ga-As Laser OTHER

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.

Ga-As Laser

Microcurrent Electrical Stimulation OTHER

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.

Microcurrent Electrical Stimulation

traditional therapy OTHER

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

Ga-As Laser; Microcurrent Electrical Stimulation; traditional therapy

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Catherine

Giza, 11251, Egypt

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema; Pain

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: Ga-As Laser and Microcurrent

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: May 25, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

EG (1)