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Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery (MRvsMLD)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lymphatic Drainage
Myofascial Release
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Myofascial-reléase, Fibromyalgia, Lymphatic drainage, Breast cancer

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women between the ages of 30 and 60 diagnosed with breast cancer undergoing conservative / partial surgery.
  • Without lymphedema or mild lymphedema.
  • They must have finished the coadjuvant treatment.

Exclusion Criteria:

  • Women with muscle or tendon lesions in the arm.
  • Kin disorders or circulatory pathology.
  • Chemotherapy or radiotherapy.
  • Surgical history in the area are excluded from the study.

Sites / Locations

  • Gemma Victoria Espí López

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Miofascial-reléase

Manual Lymphatic Drainage (MLD)

Arm Description

Myofascial Release (MR), with the purpose of releasing fascial restriction zones and major fibrosis (thoraco-brachial) caused by restriction after CM tto. IM therapy was applied to the affected area. The position of the patient was identical during both treatment sessions.

It was applied following the Leduc method with the patient in a supine position with 30º elevation of the arm and very superficial and smooth maneuvers were performed in the axillary lymph nodes, in the chest region and in the arm with the same sequence as Guerero et al. The objective of the application in our study is to obtain a beneficial treatment for the patient since it produces an increase of blood and lymphatic circulation, with positive effects on the peripheral vegetative nervous system.

Outcomes

Primary Outcome Measures

Pain
The Visual Analog Scale (EVA) was used. This scale consists of marking on a horizontal line of 10 cm in length VAS is a 10-point rating scale (0 = absolute discomfort and 10 = full comfort).

Secondary Outcome Measures

Functional Assessment of Cancer Therapy Breast
Consists of 36 items separated into two components: a general one formed by the first 27 items, and a specific one related to the symptoms of breast cancer constituted by the remaining 9 items. The survey represents five domains: physical well-being (7 items), social and family welfare (7 items), emotional well-being (6 items), functional well-being (7 items) and a specific subscale related to breast cancer and its treatment.
Disabilities of the Arm, Shoulder and Hand (DASH)
The Functional Assessment of Cancer Therapy Breast (FACT-B). This questionnaire is a specific instrument for assessing quality of life related to upper limb problems. It consists of 30 items, which assess situations of daily life and the patient responds by giving a score to each item that ranges from 1 "no difficulty", 2 "Little difficulty", 3 "Moderate difficulty", 4 "Very difficult" and 5 "Unable".
Joint mobility
The measurement of the angular travel of all the movements of the shoulder was evaluated through a universal goniometer which proved to be a valid and reliable instrument.
Depressive state
Evaluated using the patient's health questionnaire-9 (PHQ-9). It consists of 9 items that assess the presence of depressive symptoms during the last two weeks. The score range is 0-27, each item ranges from 0 (never) to 3 (more than half the days).

Full Information

First Posted
June 3, 2017
Last Updated
August 7, 2017
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03182881
Brief Title
Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery
Acronym
MRvsMLD
Official Title
Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery In Women Undergoing Conservative Surgery and Radiotherapy. Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective. To compare the effectiveness of myofascial therapy against manual lymphatic drainage in the reduction of sequelae secondary to conservative surgery and radiotherapy in women who survived breast cancer. Design. Randomized clinical trial. Site. Faculty of Physiotherapy of the University of Valencia. Participants. Twenty-four patients were included in the study. Interventions. 13 patients were randomly assigned to treatment with myofascial therapy and 11 to receive manual lymphatic drainage. Main measurements. Pain measured using the Visual Analogue Scale, shoulder joint range, shoulder functionality using the DASH questionnaire, quality of life assessed using the FACT-B questionnaire, and the depressed status of the patients using the PHQ-9 . All of this was assessed before and after treatment, and one month later as follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Myofascial-reléase, Fibromyalgia, Lymphatic drainage, Breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Miofascial-reléase
Arm Type
Experimental
Arm Description
Myofascial Release (MR), with the purpose of releasing fascial restriction zones and major fibrosis (thoraco-brachial) caused by restriction after CM tto. IM therapy was applied to the affected area. The position of the patient was identical during both treatment sessions.
Arm Title
Manual Lymphatic Drainage (MLD)
Arm Type
Active Comparator
Arm Description
It was applied following the Leduc method with the patient in a supine position with 30º elevation of the arm and very superficial and smooth maneuvers were performed in the axillary lymph nodes, in the chest region and in the arm with the same sequence as Guerero et al. The objective of the application in our study is to obtain a beneficial treatment for the patient since it produces an increase of blood and lymphatic circulation, with positive effects on the peripheral vegetative nervous system.
Intervention Type
Other
Intervention Name(s)
Lymphatic Drainage
Intervention Description
It was applied with the patient in a supine position with 30º elevation of the arm and very superficial and smooth maneuvers were performed in the axillary lymph nodes, the chest region and the arm.
Intervention Type
Other
Intervention Name(s)
Myofascial Release
Intervention Description
For the use of the treatment the bases of Pilat, A. 2016 were followed. The global and specific techniques for the periganglionar and upper thoracic region were chosen. The application of each smooth maneuver three-dimensional fascial movement has been carried out has an approximate duration of about 10 minutes and a total of 50 minutes.
Primary Outcome Measure Information:
Title
Pain
Description
The Visual Analog Scale (EVA) was used. This scale consists of marking on a horizontal line of 10 cm in length VAS is a 10-point rating scale (0 = absolute discomfort and 10 = full comfort).
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy Breast
Description
Consists of 36 items separated into two components: a general one formed by the first 27 items, and a specific one related to the symptoms of breast cancer constituted by the remaining 9 items. The survey represents five domains: physical well-being (7 items), social and family welfare (7 items), emotional well-being (6 items), functional well-being (7 items) and a specific subscale related to breast cancer and its treatment.
Time Frame
2 months
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
The Functional Assessment of Cancer Therapy Breast (FACT-B). This questionnaire is a specific instrument for assessing quality of life related to upper limb problems. It consists of 30 items, which assess situations of daily life and the patient responds by giving a score to each item that ranges from 1 "no difficulty", 2 "Little difficulty", 3 "Moderate difficulty", 4 "Very difficult" and 5 "Unable".
Time Frame
2 months
Title
Joint mobility
Description
The measurement of the angular travel of all the movements of the shoulder was evaluated through a universal goniometer which proved to be a valid and reliable instrument.
Time Frame
2 months
Title
Depressive state
Description
Evaluated using the patient's health questionnaire-9 (PHQ-9). It consists of 9 items that assess the presence of depressive symptoms during the last two weeks. The score range is 0-27, each item ranges from 0 (never) to 3 (more than half the days).
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women between the ages of 30 and 60 diagnosed with breast cancer undergoing conservative / partial surgery. Without lymphedema or mild lymphedema. They must have finished the coadjuvant treatment. Exclusion Criteria: Women with muscle or tendon lesions in the arm. Kin disorders or circulatory pathology. Chemotherapy or radiotherapy. Surgical history in the area are excluded from the study.
Facility Information:
Facility Name
Gemma Victoria Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30470892
Citation
Serra-Ano P, Ingles M, Bou-Catala C, Iraola-Lliso A, Espi-Lopez GV. Effectiveness of myofascial release after breast cancer surgery in women undergoing conservative surgery and radiotherapy: a randomized controlled trial. Support Care Cancer. 2019 Jul;27(7):2633-2641. doi: 10.1007/s00520-018-4544-z. Epub 2018 Nov 24.
Results Reference
derived

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Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery

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