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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Kinesiotherapy
Other: High voltage electrical stimulation
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.
Other: Kinesiotherapy
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.
Other: Kinesiotherapy
Other: Isquemic compression

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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