Post Mastectomy ComplicationsNCT02749539
Post Mastectomy Shoulder Problems and Kinesio Taping
A study testing Kinesio tape and physiotherapy program in people with Post Mastectomy Complications, run by Cairo University.
Trial summary
Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder problems. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Post Mastectomy Complications
- What is being tested?
- Kinesio tape and physiotherapy program
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2016
- 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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Underwent modified radical mastectomy for at least 2 weeks and taking chemotherapy and radiation therapy for stage 1 or II breast cancer.
- Presence of shoulder pain with associated limitation of motion of the shoulder.
- Good compliance and willingness to participate in kinesio taping sessions with a written consent
Who cannot join
- Still diagnosed with active breast CA at the time of the study.
- Presence of skin hypersensitivity to kinesio tape material.
- Presence of treatment contraindications including the presence of a pacemaker, heart disease, pregnancy, infectious disease, epilepsy thrombophlebitis, arterial hypertension or metastatic cancer .
- Presence of mental disturbances of the sensorium or language problems which can make communication and cooperation problematic.
About this study
Official title: Investigating the Effect of Kinesio Tape Over the Conventional Physical Therapy Management of Shoulder Related Complications in Post-mastectomy Peri-menopausal Females: A Randomized Control Trial
Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder problems.
Read the detailed description
Post-mastectomy complications are often noted and complaints by breast cancer survivors. It often involves the development of chronic arm pain with accompanying limitation of shoulder motion. Aim of the study was to investigate the effect of the kinesio tape (KT) on the shoulder pain and range of motion (ROM).
Method: 74 female patients underwent modified radical mastectomy were involved in this study. They were randomly divided into two groups, experimental who received KT for shoulder joint in addition to conventional physiotherapy program while, the control group received the physiotherapy program only. Outcome measures were visual analogues scale, shoulder ROM and shoulder Pain and Disability Index.
- Conditions
- Post Mastectomy Complications
- Being tested
- Kinesio tape, physiotherapy program
- Keywords
- Mastectomy, Shoulder Pain, ROM, Kinesio Tape
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapeDevice
Also called Kinesio TexR tape
Standard 2 -inches ( 5-m) Kinesio TexR tape was used for application in the experimental group
physiotherapy programProcedure or surgery
Also called exercises
active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises
| Study group | Role | What they receive |
|---|---|---|
| Kinesio tape | Experimental | The first 3 kinesio tape application was inhibition technique for supraspinatus, deltoid and teres minor muscles. the fourth Kinesio tape was mechanical correction for the shoulder joint. in addition to active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises Receives: Device: Kinesio tape; Procedure: physiotherapy program |
| Physiotherapy program | Active comparator | active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises Receives: Procedure: physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
It is a perpendicular line on the scale that corresponded to their perceived pain intensity.
Measured: 2 weeks change from the baseline scores
Secondary outcomes (1)
The Shoulder Pain and Disability Index (SPADI)
It consists of 13 items that assess two domains; a 5-item subscale which measures pain and an 8-item subscale which measures disability. Total score is calculated by averaging the pain and disability subscale scores.
Measured: 2 weeks change from the baseline scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Mastectomy ComplicationsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sayed A Tantawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749539
- Sponsor's protocol ID
- P.T.REC/012/001249
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: publication in a refereed journal
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Kinesio Tape Over the Conventional Physical Therapy Management of Shoulder Related Complications in Post-mastectomy Peri-menopausal Females: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02749539
- Acronym / sponsor ID
- P.T.REC/012/001249
- Conditions
- Post Mastectomy Complications
- Keywords
- Mastectomy, Shoulder Pain, ROM, Kinesio Tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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.
Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder problems.
Detailed description
Post-mastectomy complications are often noted and complaints by breast cancer survivors. It often involves the development of chronic arm pain with accompanying limitation of shoulder motion. Aim of the study was to investigate the effect of the kinesio tape (KT) on the shoulder pain and range of motion (ROM).
Method: 74 female patients underwent modified radical mastectomy were involved in this study. They were randomly divided into two groups, experimental who received KT for shoulder joint in addition to conventional physiotherapy program while, the control group received the physiotherapy program only. Outcome measures were visual analogues scale, shoulder ROM and shoulder Pain and Disability Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio tape | Experimental | Device: Kinesio tape, Procedure: physiotherapy programThe first 3 kinesio tape application was inhibition technique for supraspinatus, deltoid and teres minor muscles. the fourth Kinesio tape was mechanical correction for the shoulder joint. in addition to active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises |
| Physiotherapy program | Active comparator | Procedure: physiotherapy programactive-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Underwent modified radical mastectomy for at least 2 weeks and taking chemotherapy and radiation therapy for stage 1 or II breast cancer.
- Presence of shoulder pain with associated limitation of motion of the shoulder.
- Good compliance and willingness to participate in kinesio taping sessions with a written consent
Key exclusion criteria (4 listed)
- Still diagnosed with active breast CA at the time of the study.
- Presence of skin hypersensitivity to kinesio tape material.
- Presence of treatment contraindications including the presence of a pacemaker, heart disease, pregnancy, infectious disease, epilepsy thrombophlebitis, arterial hypertension or metastatic cancer .
- Presence of mental disturbances of the sensorium or language problems which can make communication and cooperation problematic.
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 |
|---|---|---|
| Kinesio tapeAlso: Kinesio TexR tapeStandard 2 -inches ( 5-m) Kinesio TexR tape was used for application in the experimental group | Device | Kinesio tape |
| physiotherapy programAlso: exercisesactive-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises | Procedure or surgery | Kinesio tape, Physiotherapy program |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 2 weeks change from the baseline scores
It is a perpendicular line on the scale that corresponded to their perceived pain intensity.
1 secondary outcome
The Shoulder Pain and Disability Index (SPADI)
Time frame: 2 weeks change from the baseline scores
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 25 Apr 2016.
- Individual participant dataSharing planned: Yes. publication in a refereed journal
Related trials for Post Mastectomy Complications
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Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
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Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape and physiotherapy program in people with Post Mastectomy Complications, run by Cairo University.
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 3 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 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual Analogue Scale (VAS) (time frame: 2 weeks change from the baseline scores). 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 25 Apr 2016.