Frozen Shoulder,NCT01940107
Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
A study testing evaluations and Protocol of physiotherapy exercises in people with Frozen Shoulder, and Shoulder Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Frozen Shoulder,, Shoulder Pain
- What is being tested?
- evaluations and Protocol of physiotherapy exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Sep 2012
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be diagnosed with unilateral breast cancer;
- be submitted to surgical and radiation treatment as part of the treatment for breast cancer.
Who cannot join
- patients with neurological or orthopedic diseases that could impair the upper limb movements
- bilateral breast cancer;
- prior thoracic radiotherapy;
- presence of distant metastasis.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, Saõ Paulo, 14049900
About this study
To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group
- Conditions
- Frozen Shoulder,, Shoulder Pain
- Being tested
- evaluations, Protocol of physiotherapy exercises
- Keywords
- breast cancer,, radiotherapy,, physical therapy,, upper limb
- Medical subject headings
- Bursitis, Shoulder Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluationsOther
Only evaluations
Protocol of physiotherapy exercisesProcedure or surgery
Oriented domiciliary physiotherapeutic exercises
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | Other | Control Group, which were subjected only to evaluations and to no exercise Receives: Other: evaluations |
| Study Group (SG) | Experimental | Study group (SG), was oriented to perform domiciliary exercises for the upper limbs. Receives: Procedure: Protocol of physiotherapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen Shoulder,Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helio Carrara, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940107
- Sponsor's protocol ID
- hhacarra
- Status last verified
- Sep 2013
- First submitted
- 6 Sep 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
- ClinicalTrials.gov ID
- NCT01940107
- Acronym / sponsor ID
- hhacarra
- Conditions
- Frozen Shoulder,, Shoulder Pain
- Keywords
- breast cancer,, radiotherapy,, physical therapy,, upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Sep 2013 (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.
To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | Other | Other: evaluationsControl Group, which were subjected only to evaluations and to no exercise |
| Study Group (SG) | Experimental | Procedure: Protocol of physiotherapy exercisesStudy group (SG), was oriented to perform domiciliary exercises for the upper limbs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be diagnosed with unilateral breast cancer;
- be submitted to surgical and radiation treatment as part of the treatment for breast cancer.
Key exclusion criteria (4 listed)
- patients with neurological or orthopedic diseases that could impair the upper limb movements
- bilateral breast cancer;
- prior thoracic radiotherapy;
- presence of distant metastasis.
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 |
|---|---|---|
| evaluationsOnly evaluations | Other | Control Group (CG) |
| Protocol of physiotherapy exercisesOriented domiciliary physiotherapeutic exercises | Procedure or surgery | Study Group (SG) |
Primary outcome
Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema
Time frame: 90 days
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 11 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluations and Protocol of physiotherapy exercises in people with Frozen Shoulder, and Shoulder Pain, run by University of Sao Paulo at 1 site in Brazil.
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 2 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 11 Sep 2013. 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 Brazil. 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?
Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema (time frame: 90 days). 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 11 Sep 2013.