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

• ClinicalTrials.gov Identifier: NCT03182881
• Recruitment Status: Completed
• First Posted: June 9, 2017
• Last Update Posted: August 8, 2017
• Sponsor: University of Valencia
• Information provided by (Responsible Party): GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: Lymphatic Drainage; Other: Myofascial Release	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery In Women Undergoing Conservative Surgery and Radiotherapy. Randomized Clinical Trial
• Actual Study Start Date: May 22, 2017
• Actual Primary Completion Date: June 20, 2017
• Actual Study Completion Date: July 30, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Miofascial-reléase; 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.	Other: Myofascial Release; 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.
Active Comparator: Manual Lymphatic Drainage (MLD); 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.	Other: Lymphatic Drainage; 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.

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: 2 months ]
   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 :

1. Functional Assessment of Cancer Therapy Breast [ Time Frame: 2 months ]
   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.
2. Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 2 months ]
   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".
3. Joint mobility [ Time Frame: 2 months ]
   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.
4. Depressive state [ Time Frame: 2 months ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Spain

Gemma Victoria Espí López

Valencia, Spain, 46010

Sponsors and Collaborators

University of Valencia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Serra-Añó P, Inglés M, Bou-Catalá C, Iraola-Lliso A, Espí-López 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.

• Responsible Party: GEMMA V ESPÍ LÓPEZ, PhD, Dr, University of Valencia
• ClinicalTrials.gov Identifier: NCT03182881
• Other Study ID Numbers: ID0016
• First Posted: June 9, 2017
• Last Update Posted: August 8, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia:

Myofascial-reléase; Fibromyalgia; Lymphatic drainage; Breast cancer

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases