NCT03182881

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

29 days

First QC Date

June 3, 2017

Last Update Submit

August 7, 2017

Conditions

Keywords

Myofascial-reléaseFibromyalgiaLymphatic drainageBreast cancer

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

EXPERIMENTAL

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

Manual Lymphatic Drainage (MLD)

ACTIVE COMPARATOR

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

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.

Manual Lymphatic Drainage (MLD)

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.

Miofascial-reléase

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Conditions

FibromyalgiaBreast Neoplasms

Interventions

Manual Lymphatic DrainageMyofascial Release Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

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

Locations