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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Myofascial Release; Other: Lymphatic Drainage

• Registration Number: NCT03182881
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-22
• Study First Submitted: 2017-06-03
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Primary Completion: 2017-06-20
• Study Completion: 2017-07-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Miofascial-reléase	Myofascial Release	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.
Manual Lymphatic Drainage (MLD)	Lymphatic Drainage	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.

Primary Outcome Measures

Name	Time	Method
Pain	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

Name	Time	Method
Functional Assessment of Cancer Therapy Breast	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.
Disabilities of the Arm, Shoulder and Hand (DASH)	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".
Joint mobility	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.
Depressive state	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).

Trial Locations

Locations (1)

Gemma Victoria Espí López; 🇪🇸 Valencia, Spain