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Effect of the Kinesio Taping in Fibromyalgia. (EffKtFbm)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Upper trunk group (UTG)
Global trunk group (GTG)
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Efficacy, Taping

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Upper trunk group (UTG)

Global trunk group (GTG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
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."

Secondary Outcome Measures

Comfort.
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.
Impact on quality of life.
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.
Physical well-being
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).
Trunk posture.
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.
Perception of change
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).

Full Information

First Posted
May 3, 2016
Last Updated
June 24, 2016
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT02763332
Brief Title
Effect of the Kinesio Taping in Fibromyalgia.
Acronym
EffKtFbm
Official Title
Effect of the Kinesio Taping in Patients With Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Efficacy, Taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upper trunk group (UTG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Global trunk group (GTG)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Upper trunk group (UTG)
Other Intervention Name(s)
Upper trunk
Intervention Description
This bandage was placed over the upper trapezius muscle.
Intervention Type
Other
Intervention Name(s)
Global trunk group (GTG)
Other Intervention Name(s)
Global trunk
Intervention Description
This bandage was placed globally along the back
Primary Outcome Measure Information:
Title
Pain intensity
Description
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."
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
Comfort.
Description
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.
Time Frame
three weeks
Title
Impact on quality of life.
Description
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.
Time Frame
three weeks
Title
Physical well-being
Description
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).
Time Frame
three weeks
Title
Trunk posture.
Description
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.
Time Frame
three weeks
Title
Perception of change
Description
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).
Time Frame
three weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma Espí-López, PhD
Organizational Affiliation
Faculty of Physiotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physiotherapy
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25595290
Citation
Lim EC, Tay MG. Kinesio taping in musculoskeletal pain and disability that lasts for more than 4 weeks: is it time to peel off the tape and throw it out with the sweat? A systematic review with meta-analysis focused on pain and also methods of tape application. Br J Sports Med. 2015 Dec;49(24):1558-66. doi: 10.1136/bjsports-2014-094151. Epub 2015 Jan 16.
Results Reference
result
PubMed Identifier
23306413
Citation
Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.
Results Reference
result

Learn more about this trial

Effect of the Kinesio Taping in Fibromyalgia.

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