Clinical trial NCT02859168: Myofascial Induction in Breast Cancer Survivors
Official title: Randomized, Single-blind, Placebo-controlled Cross-over Design of Myofascial Induction and Placebo Electrotherapy in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Breast Cancer
Keywords: Neck
Shoulder
Manual Therapies
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 21
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale (VAS). Change scores
timeFrame: A wash-up period of 4 weeks between the 2 sessions was established
Secondary outcomes:
measure: Goniometry shoulder. Change scores
timeFrame: A wash-up period of 4 weeks between the 2 sessions was established
measure: Goniometry cervical. Change scores
timeFrame: A wash-up period of 4 weeks between the 2 sessions was established
measure: Profile of Mood States (POMS). Change scores
timeFrame: A wash-up period of 4 weeks between the 2 sessions was established
measure: Attitudes toward massage (ATOM) scale
timeFrame: Covariates
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences. University of Granada
Study officials:
affiliation: Deparment of Physical Therapy, Faculty of Health Sciences, University of Granada
name: Manuel Arroyo-Morales, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.