Breast Cancer FemaleNCT06226688
Biofeedback Training on Shoulder Muscles Strength Post Mastectomy
A study of Breast Cancer Female, run by Cairo University at 2 sites in Egypt.
Trial summary
PURPOSE:The purpose of the study is to evaluate the effect of biofeedback on shoulder muscles strength post mastectomy. BACKGROUND: The most common complications following mastectomy are pain, ipsilateral lymphedema of the upper limb (UL), reduced range of motion (ROM) of the shoulder, flexion and abduction is limited… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Breast Cancer Female
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2023to 9 May 2024
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The subject selection will be according to the following criteria:
- Female patients with age range between 40-60 will participate in the study.
- All patients with their informed consent.
- All patients with unilateral mastectomy
- All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
- All patients with chemo or radio therapy
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- metastasis
- Psychological Disorder
- Lymphedema
- Neurological or musculoskeletal disorders
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Nourhan Souliman
Cairo, Bahyea Foundation For Breast Cancer, 02
Nourhan Ahmed mahmoud souliman
Cairo, 02
About this study
PURPOSE:The purpose of the study is to evaluate the effect of biofeedback on shoulder muscles strength post mastectomy.
BACKGROUND:
Read more
- The most common complications following mastectomy are pain, ipsilateral lymphedema of the upper limb (UL), reduced range of motion (ROM) of the shoulder, flexion and abduction is limited to 90°, and external rotation is limited to 40°, and there are postural changes
- One of the most common complications after breast cancer surgery is a functional limitation of the upper body. Up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced ROM, after surgery
- Shoulder problems in breast cancer patients affect their daily activities, such as pulling a sweater overhead, fastening a bra, zipping up a back zipper, reaching overhead, and carrying heavy bags.
- Biofeedback is a mind-body technique in which individuals learn how to modify their physiology for the purpose of improving physical, mental, emotional and spiritual health. Much like physical therapy, biofeedback training requires active participation on the part of patients and often regular practice between training sessions. Clinical biofeedback may be used to manage disease symptoms as well as to improve overall health and wellness through stress management training. Research has shown that biofeedback interventions are efficacious in treating a variety of medical conditions, and many Americans are turning to biofeedback and other less traditional therapies for their (Dana et al., 2010).
HYPOTHESES: null hypothesis
RESEARCH QUESTION: Does biofeedback give effect on shoulder muscles strength post mastectomy?
Read the detailed description
27 patient per group to G power 90% a Inclusion Criteria:
The subject selection will be according to the following criteria:
- Female patients with age range between 40-60 will participate in the study.
- All patients with their informed consent.
- All patients with unilateral mastectomy
- All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
- All patients with chemo or radio therapy 1.2.b Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
- metastasis
- Psychological Disorder
- Lymphedema
- Neurological or musculoskeletal disorders
- Conditions
- Breast Cancer Female
- Being tested
- Biofeedback device and other group control group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback device and other group control groupProcedure or surgery
Also called Expirmental trial by biofeedback device
Intervention 1 :-Using the biofeedback device with dumble to strength affected arm post mastectomy
Control groupProcedure or surgery
Also called Intervention 2 :- using traditional PT programme without using biofeedback
Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc
| Study group | Role | What they receive |
|---|---|---|
| Affected arm at the same side of mastectomy | Experimental | There is 2 arms Arm1:-arm at side of mastectomy without lymphedema trained by biofeedback Receives: Procedure: Biofeedback device and other group control group; Procedure: Control group |
| 2 arms one trained by biofeedback and other control without biofeedback | Experimental | Arm2:-arm at side of mastectomy on other group but not trained with biofeedback Training using shoulder ladder ,shoulder wheel ,shoulder mobilization and IPC Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure before and after shoulder muscles strength by hand held dynamometer
Measuring
Measured: 6 wweks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Oct 2023
- Primary completion5 May 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- RCT 2 groups One of them control group And the other is study group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Ahmed Mahmoud Souliman, Cairo University
- Investigators
- Research ethical commity Physical therapy Cairo university, Principal investigator, Research ethical commity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226688
- Sponsor's protocol ID
- P.T.REC/012/004823
- Other IDs
- 202309250044
- Status last verified
- Jul 2024
- First submitted
- 14 Jan 2024
- Last updated
- 2 Aug 2024
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback Training on Shoulder Muscles Strength Post Mastectomy
- ClinicalTrials.gov ID
- NCT06226688
- Acronym / sponsor ID
- P.T.REC/012/004823
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 26 Jan 2024 (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.
PURPOSE:The purpose of the study is to evaluate the effect of biofeedback on shoulder muscles strength post mastectomy.
BACKGROUND:
- The most common complications following mastectomy are pain, ipsilateral lymphedema of the upper limb (UL), reduced range of motion (ROM) of the shoulder, flexion and abduction is limited to 90°, and external rotation is limited to 40°, and there are postural changes
- One of the most common complications after breast cancer surgery is a functional limitation of the upper body. Up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced ROM, after surgery
- Shoulder problems in breast cancer patients affect their daily activities, such as pulling a sweater overhead, fastening a bra, zipping up a back zipper, reaching overhead, and carrying heavy bags.
- Biofeedback is a mind-body technique in which individuals learn how to modify their physiology for the purpose of improving physical, mental, emotional and spiritual health. Much like physical therapy, biofeedback training requires active participation on the part of patients and often regular practice between training sessions. Clinical biofeedback may be used to manage disease symptoms as well as to improve overall health and wellness through stress management training. Research has shown that biofeedback interventions are efficacious in treating a variety of medical conditions, and many Americans are turning to biofeedback and other less traditional therapies for their (Dana et al., 2010).
HYPOTHESES: null hypothesis
RESEARCH QUESTION: Does biofeedback give effect on shoulder muscles strength post mastectomy?
Detailed description
27 patient per group to G power 90% a Inclusion Criteria:
The subject selection will be according to the following criteria:
- Female patients with age range between 40-60 will participate in the study.
- All patients with their informed consent.
- All patients with unilateral mastectomy
- All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
- All patients with chemo or radio therapy 1.2.b Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
- metastasis
- Psychological Disorder
- Lymphedema
- Neurological or musculoskeletal disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- RCT 2 groups One of them control group And the other is study group
| Arm | Type | Receives |
|---|---|---|
| Affected arm at the same side of mastectomy | Experimental | Procedure: Biofeedback device and other group control group, Procedure: Control groupThere is 2 arms Arm1:-arm at side of mastectomy without lymphedema trained by biofeedback |
| 2 arms one trained by biofeedback and other control without biofeedback | Experimental | Procedure: Control groupArm2:-arm at side of mastectomy on other group but not trained with biofeedback Training using shoulder ladder ,shoulder wheel ,shoulder mobilization and IPC |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subject selection will be according to the following criteria:
- Female patients with age range between 40-60 will participate in the study.
- All patients with their informed consent.
- All patients with unilateral mastectomy
- All patients have shoulder muscle weakness within 2 to 4 months post mastectomy
Key exclusion criteria (5 listed)
- The potential participants will be excluded if they meet one of the following criteria:
- metastasis
- Psychological Disorder
- Lymphedema
- Neurological or musculoskeletal disorders
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 |
|---|---|---|
| Biofeedback device and other group control groupAlso: Expirmental trial by biofeedback deviceIntervention 1 :-Using the biofeedback device with dumble to strength affected arm post mastectomy | Procedure or surgery | Affected arm at the same side of mastectomy |
| Control groupAlso: Intervention 2 :- using traditional PT programme without using biofeedbackShoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc | Procedure or surgery | 2 arms one trained by biofeedback and other control without biofeedback, Affected arm at the same side of mastectomy |
Primary outcome
Measure before and after shoulder muscles strength by hand held dynamometer
Time frame: 6 wweks
Measuring
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 2 Aug 2024.
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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.
Research ethical commity Physical therapy Cairo university principal investigator
Research ethical commity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Breast Cancer Female, run by Cairo University at 2 sites 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 6 inclusion and 5 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 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Measure before and after shoulder muscles strength by hand held dynamometer (time frame: 6 wweks). 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 2 Aug 2024.