Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors

NCT ID: NCT02406794

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-03-31

Brief Summary

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Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various points in order to improve symptoms and increase adherence.

Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment. Clinical and patient data were obtained from medical histories, genetic and proteomic analysis, grip strength and algometry measured, questionnaires and the outcome of interest, their VAS. NMT is applied in four possible locations, according to the symptoms of each participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more interventions before repeating the readings from the last five weeks of the start of the study.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Neuromuscular taping

The first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).

Group Type EXPERIMENTAL

Neuromuscular taping

Intervention Type DRUG

The first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).

No Kinesio taping

No Kinesio taping

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neuromuscular taping

The first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).

Intervention Type DRUG

Other Intervention Names

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Kinesio taping

Eligibility Criteria

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Inclusion Criteria

* To be of legal age
* Having suffered from primary breast cancer with histological confirmation (I-IIIA)
* Completion of primary carcinoma treatment (surgery, chemotherapy, radiotherapy)
* To be receiving hormone therapy as an adjunct to the process by aromatase inhibitors (exemestane, anastrozole, letrozole)
* To present a functional status according to WHO from 0 (asymptomatic, complete and ambulatory activity) or 1 (symptomatic but completely ambulatory, strenuous physical activity restricted but able to perform sedentary gentle activities)
* To understand correctly Spanish
* To show their approval by signing the informed consent
* Having had musculoskeletal disorders attributable to IA.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Dr. Antonio I Cuesta-Vargas

Professor of Faculty of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio I Cuesta-Vargas, PhD

Role: STUDY_DIRECTOR

University of Malaga

Inmaculada Conejo-Tirado

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Locations

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Regional University Hospital Virgen de la Victoria

Málaga, Malaga, Spain

Site Status

Countries

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Spain

References

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Conejo I, Pajares B, Alba E, Cuesta-Vargas AI. Effect of neuromuscular taping on musculoskeletal disorders secondary to the use of aromatase inhibitors in breast cancer survivors: a pragmatic randomised clinical trial. BMC Complement Altern Med. 2018 Jun 11;18(1):180. doi: 10.1186/s12906-018-2236-3.

Reference Type DERIVED
PMID: 29890985 (View on PubMed)

Other Identifiers

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FCCSS-UMA_01-13

Identifier Type: -

Identifier Source: org_study_id

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