Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery
MRvsMLD
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2017
CompletedFirst Submitted
Initial submission to the registry
June 3, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2017
CompletedAugust 8, 2017
August 1, 2017
29 days
June 3, 2017
August 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
2 months
Secondary Outcomes (4)
Functional Assessment of Cancer Therapy Breast
2 months
Disabilities of the Arm, Shoulder and Hand (DASH)
2 months
Joint mobility
2 months
Depressive state
2 months
Study Arms (2)
Miofascial-reléase
EXPERIMENTALMyofascial 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.
Manual Lymphatic Drainage (MLD)
ACTIVE COMPARATORIt 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gemma Victoria Espí López
Valencia, 46010, Spain
Related Publications (1)
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.
PMID: 30470892DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 3, 2017
First Posted
June 9, 2017
Study Start
May 22, 2017
Primary Completion
June 20, 2017
Study Completion
July 30, 2017
Last Updated
August 8, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share