- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02181166
Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies
July 1, 2014 updated by: Vânia Tie Koga Ferreira, University of Sao Paulo
Myofascial pain considerably affects women undergoing treatment for breast cancer, is characterized by the presence of myofascial taut bands and trigger points.
This study aims to evaluate the effects of ischemic compression, high-voltage electrical stimulation and rehabilitation of kinesio in women with myofascial pain following treatment of breast cancer.
This is a randomized blind controlled study.
For this, we invited 60 volunteers undergoing treatment for breast cancer, randomized and allocated into three groups: G1 (cinesioterapia), G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical stimulation cinesioterapia +).
The stance, the plantar pressure distribution and the balance will be assessed by means of photogrammetry and baropodometry respectively.
Myofascial trigger points will be assessed with the use of infrared thermography, algometry and numerical rating scale of pain (END).
Moreover, the quality of life of the volunteers will be assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B +4).
The volunteers will undergo 10 sessions of treatment, and reassessed at the end of treatment and after thirty days.
Normality test is used to verify data distribution and consistent statistical test for proper intra and comparisons between groups, being thus considered two factors in the comparisons, time and group.
A significance level of 5% is assumed.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14049-900
- University of Sao Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- mastectomy
- aged between 35 and 70 years
- myofascial trigger point in the upper trapezius muscle
Exclusion Criteria:
- metastasis or recurrence of breast cancer
- bilateral mastectomy
- in physiotherapy treatment
- degenerative diseases of the spine
- use of muscle relaxants or anti-inflammatory analgesics in the last week
- report of fibromyalgia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: kinesiotherapy + High voltage electrical stimulation
Same protocol group kinesiotherapy + high voltage electrial stimulation with two rectangular electrodes (3x5 cm) active silicon-carbon and an electrode rectangular dispersive (10x18cm) aluminum wrapped with a damp felt in water.
The active electrodes are positioned in central myofascial trigger point of the upper trapezius muscle after application of water soluble gel.
The dispersive electrode was placed in the lumbar region.
The following parameters will be use: frequency of 10 Hz, twin pulses of 20μs to 100ms between pulses and the maximum voltage tolerated by voluntary until the motor threshold (visible muscle contraction) to increase every five minutes, totaling 30 minutes of stimulation.
The negative polarity will be use.
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Experimental: Kinesiotherapy group
The volunteer will be subjected to the following protocol: These exercises involve stretching of the cervical, anterior and posterior chain of the upper trunk and active mobilization of the cervical, shoulder movements of flexion, extension, abduction and adduction of the shoulder and upper limb.
The exercises lasted 50 minutes, with 10 minutes of walking, and stretching was performed with two repetitions of 20 seconds, and active mobilization exercises of three sets of eight repetitions and final relaxation of 10 minutes were performed.
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Experimental: kineshioterapy + isquemic compression
The same protocol group kinesiotherapy + ischemic compression in central myofascial trigger point of the upper trapezius muscle.
This procedure was performed for 90 seconds.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 2 years
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Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 2 years
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Through a Functional Assessment of Cancer Therapy- Breast (FACT B + 4).
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2 years
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Skin Temperature
Time Frame: 2 years
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Through of thermograph will be evaluated skin temperature on myofascial trigger points.
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2 years
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Posture
Time Frame: 2 years
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Through computerized photogrammetry postural assessment.
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vânia Ferreira, PT, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
January 1, 2015
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
July 1, 2014
First Submitted That Met QC Criteria
July 1, 2014
First Posted (Estimate)
July 3, 2014
Study Record Updates
Last Update Posted (Estimate)
July 3, 2014
Last Update Submitted That Met QC Criteria
July 1, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1158-7302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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