Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

Not Applicable

• Conditions: Breast Cancer; Myofascial Trigger Point

• Registration Number: NCT02181166
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Last Update Submitted: 2014-07-01
• Study First Posted: 2014-07-03
• Last Update Posted: 2014-07-03
• Study Start: 2014-08
• Primary Completion: 2015-01
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil