Post Mastectomy LymphedemaPMNCT05870241
Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation
A study testing Ga-As Laser, Microcurrent Electrical Stimulation and traditional therapy in people with Post Mastectomy Lymphedema, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is to investigate the effect of GA-AS laser versus microcurrent on post-mastectomy shoulder pain and lymphedema. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Post Mastectomy Lymphedema
- What is being tested?
- Ga-As Laser, Microcurrent Electrical Stimulation and traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
the aim of this study is to investigate the effect of GA-AS laser versus microcurrent on post-mastectomy shoulder pain and lymphedema.
Read the 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.
- Conditions
- Post Mastectomy Lymphedema
- Being tested
- Ga-As Laser, Microcurrent Electrical Stimulation, traditional therapy
- Keywords
- post mastectomy, lymphedema, pain, Ga-As Laser, Microcurrent
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-As LaserOther
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.
Microcurrent Electrical StimulationOther
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.
traditional therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Ga-As Laser | Experimental | the patients will receive Ga-As Laser and traditional therapy three times a week for three months Receives: 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 Receives: Other: Microcurrent Electrical Stimulation; Other: traditional therapy |
| traditional therapy | Active comparator | the patients will receive traditional therapy three times a week for three months Receives: Other: traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
pain intensity will be measured by visual analogue scale
Measured: 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)
Measured: up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start25 May 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Mastectomy LymphedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ga-As Laser and Microcurrent
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Moanis Labib Botros, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870241
- Sponsor's protocol ID
- P.T.REC/012/003506
- Acronym
- PM
- Status last verified
- Oct 2023
- First submitted
- 12 May 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation
- ClinicalTrials.gov ID
- NCT05870241
- Acronym / sponsor ID
- PM / P.T.REC/012/003506
- Conditions
- Post Mastectomy Lymphedema
- Keywords
- post mastectomy, lymphedema, pain, Ga-As Laser, Microcurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Ga-As Laser and Microcurrent
| Arm | Type | Receives |
|---|---|---|
| Ga-As Laser | Experimental | Other: Ga-As Laser, Other: traditional therapythe patients will receive Ga-As Laser and traditional therapy three times a week for three months |
| Microcurrent Electrical Stimulation | Experimental | Other: Microcurrent Electrical Stimulation, Other: traditional therapythe patients will receive Microcurrent Electrical Stimulation and traditional therapy three times a week for three months |
| traditional therapy | Active comparator | Other: traditional therapythe patients will receive traditional therapy three times a week for three months |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-As LaserPatient 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. | Other | Ga-As Laser |
| Microcurrent Electrical StimulationThe 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. | Other | Microcurrent Electrical Stimulation |
| traditional therapythe 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 | Other | Ga-As Laser, Microcurrent Electrical Stimulation, traditional therapy |
Primary outcome
pain intensity
Time frame: up to twelve weeks
pain intensity will be measured by visual analogue scale
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
Related trials for Post Mastectomy Lymphedema
Recruiting
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
Post Mastectomy Lymphedema
Enrolling by invitation
Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy
Mastectomy; Lymphedema
Recruiting
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Breast Cancer Surgery
Paravertebral Block, Pectoral Nerve Block
Active, not recruiting
Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy
Breast Cancer Related Lymphedema
Recruiting
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Mastectomy; Lymphedema, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga-As Laser, Microcurrent Electrical Stimulation and traditional therapy in people with Post Mastectomy Lymphedema, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: up to twelve weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.