Effect of the Kinesio Taping in Fibromyalgia. (EffKtFbm)

June 24, 2016 updated by: GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

Effect of the Kinesio Taping in Patients With Fibromyalgia.

The prevalence of the fibromyalgia is about 10-15% in the European countries. It is unclear the etiology and pathogenesis of the syndrome. Several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved. But the symptom commonly expressed by the people who suffer from it is pain.

The main goal of the present study is to analyse the effect of the kinesiotaping on the pain, comfort and postural position of the patient with fibromyalgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All of the participants were recruited, in a non-probabilistic way, from the Valencian Association of Affected of Fibromyalgia from date to april 2016. Inclusion criteria include: age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria. Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia. People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.

The participants were randomly allocated (random numbers table) to two different groups depending on the placement of the Kinesio Tape © (KT) by a physiotherapist which did not participated in the study. Thus, one group was composed by 18 women and was called "Upper trunk group" (UTG). The other group, composed by 17 women and called "Global trunk group" (GTG).

Patients were informed about the purpose of the study, procedures and risks, and they provided written informed consent before the treatment. The study protocol was approved by the authors´ University Ethic Committee where the study was conducted. All procedures were conducted in accordance to the Declaration of Helsinki.

A prospective, randomized, double blind, controlled trial was carried out. Participants were assessed two times, one before the intervention and another afterwards. They received a treatment of kinesiotaping during three weeks. Participants came to our laboratory each week in order to change their bandage and assure the adherence to the treatment.

The physiotherapist who conducted the assessments was blinded to the treatment received by the patients and the statistician was completely blinded to the goals of the study. The physiotherapist who applied the treatment had an extensive experience Kinesio Tape ©.

All enrolled participants were aware that they could receive two types of treatments but did not know the purposes of each treatment. They were instructed to not change their daily routines.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Faculty of Physiotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age between 18 and 70 years old and diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) diagnostic criteria (Wolfe et al., 2011). Once they expressed their interest in taking part of the study, potential participants underwent an examination by a rheumatologist of the association to confirm the diagnosis of fibromyalgia.

Exclusion Criteria:

  • People with other different diagnosis, musculoskeletal or neurological disorders that prevented the follow-up study, infections, whiplash, migraine, skin hypersensitivity or heart devices were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upper trunk group (UTG)
In the UTG, the bandage was applied over the superior fibbers of the trapezious and levator scapulae muscle using a strip in a 'Y' shape. The individuals were asked to remain in an upright sitting position and the base of the strip was attached to the skin beyond the acromion without any tension. Later, we placed the two straps of the bandage with a range of tension from 15 to 25%. The main goal of this shape is achieve muscular relaxation of the trapezius, scapula levator and supraspinatus.
Other: Upper trunk group (UTG)
This bandage was placed over the upper trapezius muscle.
Other Names:
  • Upper trunk
Active Comparator: Global trunk group (GTG)
In the GTG the bandage was applied parallel to the paravertebral muscles in a 'C' shape. The individuals were sit in the same position with the head in the neutral position. The strip was pasted with approximately 25% of tension all over the paravertebral musculature. The main goal was procuring a global mechanical correction of the superior part of the trunk.
Other: Global trunk group (GTG)
This bandage was placed globally along the back
Other Names:
  • Global trunk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: three weeks
The pain intensity was recorded by a visual analogue scale (VAS) of pain. The pain was expressed on a scale of 0-10, with 0 being "no pain" and 10 "maximum tolerable pain."
three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort.
Time Frame: three weeks
Five VAS were used to identify their level of comfort in the following corporal regions: head-neck, shoulders, thoracic segment, lumbar region and pelvic region (0=absolute discomfort and 10=full comfort). Participants placed a mark along the line in order to measure their comfort level, which was scored to the nearest centimeter.
three weeks
Impact on quality of life.
Time Frame: three weeks
The Fibromyalgia Impact Questionnaire (FIQ) was used to assess the functional status of this population. This questionnaire is composed of 10 questions. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
three weeks
Physical well-being
Time Frame: three weeks
Was determined using self-administered questionnaire, designed for this purpose included a 16-item. The reliability of the questionnaire was analyzed by Cronbach's alpha coefficient, which indicated a good internal consistency (α = 0.70).
three weeks
Trunk posture.
Time Frame: three weeks
To assess the position of the superior part of the trunk, the evaluation of the minor pectoral length in supine position was employed, taking the distance (with a tape measure) between the posterior edge of the acromion to the stretcher while the patients remain in that position with their hands laying on their belly.
three weeks
Perception of change
Time Frame: three weeks
Was evaluated with the Patient's Global Impression of Change scale after treatment. Participants were asked to score their perception of changing after the intervention received with a one-item questionnaire with seven alternatives (1= maximum change to 7 = no change at all).
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Gemma Espí-López, PhD, Faculty of Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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