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Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

Primary Purpose

Breast Cancer, Myofascial Trigger Point

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Kinesiotherapy
Isquemic compression
High voltage electrical stimulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Neoplasms, Mastectomy, Myofascial pain syndromes, Physical Therapy Modalities

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

kinesiotherapy + High voltage electrical stimulation

Kinesiotherapy group

kineshioterapy + isquemic compression

Arm Description

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.

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.

The same protocol group kinesiotherapy + ischemic compression in central myofascial trigger point of the upper trapezius muscle. This procedure was performed for 90 seconds.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 1, 2014
Last Updated
July 1, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02181166
Brief Title
Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Myofascial Trigger Point
Keywords
Breast Neoplasms, Mastectomy, Myofascial pain syndromes, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kinesiotherapy + High voltage electrical stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Kinesiotherapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
kineshioterapy + isquemic compression
Arm Type
Experimental
Arm Description
The same protocol group kinesiotherapy + ischemic compression in central myofascial trigger point of the upper trapezius muscle. This procedure was performed for 90 seconds.
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy
Intervention Type
Other
Intervention Name(s)
Isquemic compression
Intervention Type
Other
Intervention Name(s)
High voltage electrical stimulation
Primary Outcome Measure Information:
Title
Pain
Description
Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of life
Description
Through a Functional Assessment of Cancer Therapy- Breast (FACT B + 4).
Time Frame
2 years
Title
Skin Temperature
Description
Through of thermograph will be evaluated skin temperature on myofascial trigger points.
Time Frame
2 years
Title
Posture
Description
Through computerized photogrammetry postural assessment.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vânia Ferreira, PT
Phone
+551636020215
Email
vaniatie@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vânia Ferreira, PT
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vânia Ferreira, PT
Phone
+551636020215
Email
vaniatie@hotmail.com
First Name & Middle Initial & Last Name & Degree
Vânia Ferreira, PT

12. IPD Sharing Statement

Links:
URL
http://www.fmrp.usp.br
Description
Related Info

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Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

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