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

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

    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • University of Sao Paulo

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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 2 years
Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 2 years
Through a Functional Assessment of Cancer Therapy- Breast (FACT B + 4).
2 years
Skin Temperature
Time Frame: 2 years
Through of thermograph will be evaluated skin temperature on myofascial trigger points.
2 years
Posture
Time Frame: 2 years
Through computerized photogrammetry postural assessment.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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