Myofascial Induction in Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Breast Cancer

Intervention / Treatment
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* Behavioral: Myofascial Induction
* Device: Unplugged pulsed shortwave therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck, Shoulder, Manual Therapies