Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02181166
• Other study ID #: U1111-1158-7302
• Status: Not yet recruiting
• Phase: N/A
• First received: July 1, 2014
• Last updated: July 1, 2014
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2014
• Source: University of Sao Paulo
• Contact: Vânia Ferreira, PT
• Phone: +551636020215
• Email: vaniatie[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Fibromyalgia
• Myofascial Pain Syndromes
• Myofascial Trigger Point

Intervention

Other:
• Kinesiotherapy

• Isquemic compression

• High voltage electrical stimulation

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).	2 years	No
Secondary	Quality of life	Through a Functional Assessment of Cancer Therapy- Breast (FACT B + 4).	2 years	No
Secondary	Skin Temperature	Through of thermograph will be evaluated skin temperature on myofascial trigger points.	2 years	No
Secondary	Posture	Through computerized photogrammetry postural assessment.	2 years	No

External Links

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