Myofascial Induction in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859168
• Other study ID #: FIS PI10/02749-02764
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Pain

Intervention

Behavioral:
• Myofascial Induction
Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach.

Device:
• Unplugged pulsed shortwave therapy
Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences. University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Castro-Martín E, Ortiz-Comino L, Gallart-Aragón 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 P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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