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Completed

NCT Number: NCT02859168

Myofascial Induction 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.

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Key information

Conditions

Pain Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences. University of Granada

Granada, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Myofascial Induction

Behavioral

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

Unplugged pulsed shortwave therapy

Device

Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.

Primary outcomes

  1. Visual Analogue Scale (VAS). Change scores

    Time frame: A wash-up period of 4 weeks between the 2 sessions was established

    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.

Secondary outcomes

  1. Goniometry shoulder. Change scores

    Time frame: A wash-up period of 4 weeks between the 2 sessions was established

    A plastic universal goniometer with two adjustable overlapping arms to measure the active range of motion of the shoulder joint.

  2. Goniometry cervical. Change scores

    Time frame: A wash-up period of 4 weeks between the 2 sessions was established

    A cervical goniometric device manufactured by Performance Attainment Associates (St Paul, MN, USA) to measure the active range of motion of the cervical joints.

  3. Profile of Mood States (POMS). Change scores

    Time frame: A wash-up period of 4 weeks between the 2 sessions was established

    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.

  4. Attitudes toward massage (ATOM) scale

    Time frame: Covariates

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2016
Registry last updated
Oct 18, 2021

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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