NCT02859168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

3.2 years

First QC Date

August 1, 2016

Last Update Submit

October 13, 2021

Conditions

PainBreast Cancer

Keywords

NeckShoulderManual Therapies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Goniometry shoulder. Change scores

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

  • Goniometry cervical. Change scores

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

  • Profile of Mood States (POMS). Change scores

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

  • Attitudes toward massage (ATOM) scale

    Covariates

Study Arms (2)

Myofascial Induction session

EXPERIMENTAL

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

Behavioral: Myofascial Induction

Placebo session

PLACEBO COMPARATOR

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

Device: Unplugged pulsed shortwave therapy

Interventions

Myofascial InductionBEHAVIORAL

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

Myofascial Induction session
Unplugged pulsed shortwave therapyDEVICE

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

Placebo session

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • had cancer recurrence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Granada

Granada, 18016, Spain

Location

Related Publications (1)

  • 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.

    PMID: 28003133RESULT

MeSH Terms

Conditions

PainBreast Neoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Manuel Arroyo-Morales, PhD

    Deparment of Physical Therapy, Faculty of Health Sciences, University of Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 8, 2016

Study Start

June 1, 2014

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations

ES(1)