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Completed

NCT Number: NCT03182881

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

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.

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Key information

Conditions

Fibromyalgia Breast Diseases Breast Neoplasms Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gemma Victoria Espí López

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lymphatic drainage

Other

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

Other

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery In Women Undergoing Conservative Surgery and Radiotherapy. Randomized Clinical Trial

Acronym: MRvsMLD

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2017
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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