Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Vânia Tie Koga Ferreira, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02181166
First received: July 1, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Myofascial Trigger Point
Other: Kinesiotherapy
Other: Isquemic compression
Other: High voltage electrical stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Through a Functional Assessment of Cancer Therapy- Breast (FACT B + 4).

  • Skin Temperature [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Through of thermograph will be evaluated skin temperature on myofascial trigger points.

  • Posture [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Through computerized photogrammetry postural assessment.


Estimated Enrollment: 60
Study Start Date: August 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02181166

Contacts
Contact: Vânia Ferreira, PT +551636020215 vaniatie@hotmail.com

Locations
Brazil
University of Sao Paulo Not yet recruiting
Ribeirão Preto, São Paulo, Brazil, 14049-900
Contact: Vânia Ferreira, PT    +551636020215    vaniatie@hotmail.com   
Principal Investigator: Vânia Ferreira, PT         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Vânia Ferreira, PT University of São Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Vânia Tie Koga Ferreira, PT, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02181166     History of Changes
Other Study ID Numbers: U1111-1158-7302
Study First Received: July 1, 2014
Last Updated: July 1, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Breast Neoplasms
Mastectomy
Myofascial pain syndromes
Physical Therapy Modalities

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Breast Neoplasms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014