Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

NCT ID: NCT02181166

Last Updated: 2014-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Myofascial Trigger Point

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Kinesiotherapy

Intervention Type OTHER

High voltage electrical stimulation

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Kinesiotherapy

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Kinesiotherapy

Intervention Type OTHER

Isquemic compression

Intervention Type OTHER

Interventions

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Kinesiotherapy

Intervention Type OTHER

Isquemic compression

Intervention Type OTHER

High voltage electrical stimulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Vânia Tie Koga Ferreira

PT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vânia Ferreira, PT

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Vânia Ferreira, PT

Role: CONTACT

+551636020215

Facility Contacts

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Vânia Ferreira, PT

Role: primary

+551636020215

Related Links

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Other Identifiers

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U1111-1158-7302

Identifier Type: -

Identifier Source: org_study_id

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