Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

Not Applicable

• Conditions: Breast Cancer; Myofascial Trigger Point
• Interventions: Other: Kinesiotherapy; Other: High voltage electrical stimulation; Other: Isquemic compression

• 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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
kinesiotherapy + High voltage electrical stimulation	Kinesiotherapy	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.
kinesiotherapy + High voltage electrical stimulation	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.
Kinesiotherapy group	Kinesiotherapy	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.
kineshioterapy + isquemic compression	Kinesiotherapy	The same protocol group kinesiotherapy + ischemic compression in central myofascial trigger point of the upper trapezius muscle. This procedure was performed for 90 seconds.
kineshioterapy + isquemic compression	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.

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
Posture	2 years	Through computerized photogrammetry postural assessment.
Quality of life	2 years	Through a Functional Assessment of Cancer Therapy- Breast (FACT B + 4).
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