Myofascial Induction in Breast Cancer Survivors

Randomized, Single-blind, Placebo-controlled Cross-over Design of Myofascial Induction and Placebo Electrotherapy in Breast Cancer Survivors

The purpose of this study was to show the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.

Study Overview

• Status: Completed
• Conditions: Pain; Breast Cancer
• Intervention / Treatment: Behavioral: Myofascial Induction; Device: Unplugged pulsed shortwave therapy

Detailed Description

Background: To investigate the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.

Methods: Randomized, single-blind, placebo-controlled cross-over study. Twenty-one enrolled participants who had a diagnosis of breast cancer stage I-IIIA and had completed adjuvant therapy except hormonal treatment. The study consisted of two intervention sessions of 30 minutes separated by a wash-up period of 4 weeks. The interventions consisted of a Myofascial Induction (experimental group) or placebo pulsed shortwave therapy (control group). The main outcome measures were: Visual Analogue Scale for pain and anxiety, shoulder-cervical goniometry for range of motion, Profile of Mood States for psychological distress and Attitudes Toward Massage Scale.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18016
    • Faculty of health Sciences. University of Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• had a diagnosis of breast cancer (cancer stage I-IIIA)
• was between the ages of 25 and 65
• had completed adjuvant therapy except hormonal treatment

Exclusion Criteria:

• had cancer recurrence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Myofascial Induction session; Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach.	Behavioral: Myofascial Induction; Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach.
Placebo Comparator: Placebo session; Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.	Device: Unplugged pulsed shortwave therapy; Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS). Change scores	A numerical rating scale that contains scores in the range of 0 to 10 (0 = 'no pain/anxiety'; 10 = 'worst imaginable pain/anxiety level'). Participants must mark the level of pain that they feel at that moment in the cervical-arm area and use the scale to indicate their anxiety level.	A wash-up period of 4 weeks between the 2 sessions was established

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goniometry shoulder. Change scores	A plastic universal goniometer with two adjustable overlapping arms to measure the active range of motion of the shoulder joint.	A wash-up period of 4 weeks between the 2 sessions was established
Goniometry cervical. Change scores	A cervical goniometric device manufactured by Performance Attainment Associates (St Paul, MN, USA) to measure the active range of motion of the cervical joints.	A wash-up period of 4 weeks between the 2 sessions was established
Profile of Mood States (POMS). Change scores	This questionnaire is a measure of psychological distress. This questionnaire contains 65 items assessing mood state, which are grouped into six subscales: tension-anxiety, depression-dejection, anger-hostility, vigour-activity, fatigue-inertia and confusion-bewilderment.	A wash-up period of 4 weeks between the 2 sessions was established
Attitudes toward massage (ATOM) scale	The Attitudes toward massage (ATOM) scale is a nine-item measure of overall attitude toward massage composed of the 'Massage as Healthful' and the 'Massage as Pleasant' subscales.	Covariates

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Manuel Arroyo-Morales, PhD, Deparment of Physical Therapy, Faculty of Health Sciences, University of Granada

Publications and helpful links

General Publications

• Castro-Martin E, Ortiz-Comino L, Gallart-Aragon T, Esteban-Moreno B, Arroyo-Morales M, Galiano-Castillo N. Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design. Arch Phys Med Rehabil. 2017 May;98(5):832-840. doi: 10.1016/j.apmr.2016.11.019. Epub 2016 Dec 18.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Shoulder; Neck; Manual Therapies
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: FIS PI10/02749-02764