Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

NCT02181166 | Unknown

• 1 other identifier: U1111-1158-7302
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Myofascial Trigger Point

Keywords

Breast Neoplasms; Mastectomy; Myofascial pain syndromes; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• Pain

  Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).

  2 years

Secondary Outcomes (3)

• Quality of life

  2 years

• Skin Temperature

  2 years

• Posture

  2 years

Study Arms (3)

kinesiotherapy + High voltage electrical stimulation

EXPERIMENTAL

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

Kinesiotherapy group

EXPERIMENTAL

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

kineshioterapy + isquemic compression

EXPERIMENTAL

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

Interventions

Kinesiotherapy OTHER

Kinesiotherapy group; kineshioterapy + isquemic compression; kinesiotherapy + High voltage electrical stimulation

Isquemic compression OTHER

kineshioterapy + isquemic compression

High voltage electrical stimulation OTHER

kinesiotherapy + High voltage electrical stimulation

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mastectomy
• aged between 35 and 70 years
• myofascial trigger point in the upper trapezius muscle

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Vânia Ferreira, PT

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vânia Ferreira, PT

CONTACT

+551636020215; vaniatie@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 3, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2016
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

BR (1)