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

U

University of Malaga

Status and phase

Completed
Phase 2
Phase 1

Conditions

Breast Neoplasms

Treatments

Drug: Neuromuscular taping

Study type

Interventional

Funder types

Other

Identifiers

NCT02406794
FCCSS-UMA_01-13

Details and patient eligibility

About

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.

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

156 participants in 2 patient groups

Neuromuscular taping
Experimental group
Description:
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).
Treatment:
Drug: Neuromuscular taping
No Kinesio taping
No Intervention group
Description:
No Kinesio taping

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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