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

Fibromyalgia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182881
• Other study ID #: ID0016
• Status: Completed
• Phase: N/A
• First received: June 3, 2017
• Last updated: August 7, 2017
• Start date: May 22, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: August 2017
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 30, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Gemma Victoria Espí López	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 months
Secondary	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".	2 months
Secondary	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.	2 months
Secondary	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).	2 months