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Myofascial Induction in Breast Cancer Survivors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02859168
Enrollment
21
Registered
2016-08-08
Start date
2014-06-30
Completion date
2017-10-31
Last updated
2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Pain

Keywords

Neck, Shoulder, Manual Therapies

Brief 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.

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.

Interventions

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

DEVICEUnplugged pulsed shortwave therapy

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

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS). Change scoresA wash-up period of 4 weeks between the 2 sessions was establishedA 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

MeasureTime frameDescription
Goniometry shoulder. Change scoresA wash-up period of 4 weeks between the 2 sessions was establishedA plastic universal goniometer with two adjustable overlapping arms to measure the active range of motion of the shoulder joint.
Goniometry cervical. Change scoresA wash-up period of 4 weeks between the 2 sessions was establishedA cervical goniometric device manufactured by Performance Attainment Associates (St Paul, MN, USA) to measure the active range of motion of the cervical joints.
Profile of Mood States (POMS). Change scoresA wash-up period of 4 weeks between the 2 sessions was establishedThis 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.
Attitudes toward massage (ATOM) scaleCovariatesThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026