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Effects of Core Stabilization Exercise Plus Kinesio Taping in Woman With Fibromyalgia

Primary Purpose

Fibromyalgia, Exercise, Rheumatic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Core stabilization exercise group
Core stabilization exercise plus kinesio taping group
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosed with Fibromyalgia, being woman, having moderate or severe pain according to Visual Analog Scale, 18-65 years of age and being volunteer for the study

Exclusion Criteria:

  • having neurologic, infectious, and endocrine diseases, malignancy, being pregnant, severe psychological disorders, any changing of medications during treatment, being allergic to taping, any condition interfering with exercise (advanced cardiac, respiratory or musculoskeletal problems), and intervention including exercise program or physical therapy in the last 6 months.

Sites / Locations

  • Ankara Yildirim Beyazit UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Core stabilization exercise group

Core stabilization exercise plus kinesio taping group

Arm Description

Core stabilization exercise (CSE): The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional.

Core stabilization exercise (CSE): The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional. Kinesio Taping: The Kinesio Taping was carried out 2 days a week for 6 weeks (12 sessions) by experienced and certificated physiotherapist. Kinesio taping was applied to spinal region.

Outcomes

Primary Outcome Measures

Pain level
Pain level was assessed with Visual Analog Scale.

Secondary Outcome Measures

Health Status
Health status of participants were assessed with Turkish version of Fibromyalgia Impact Questionnaire.
Life Quality
Quality of Life was assessed with Turkish version of Nottingham Health Profile
Depression
Depression was assessed with Turkish version of Beck Depression Inventory
Sleep Quality
Sleep quality was assessed with Jenkins Sleep Scale.
Fatigue
Fatigue was assessed with Visual Analog Scale

Full Information

First Posted
June 23, 2019
Last Updated
June 24, 2019
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT03997695
Brief Title
Effects of Core Stabilization Exercise Plus Kinesio Taping in Woman With Fibromyalgia
Official Title
A Comparison of the Effects of Core Stabilization Exercise Plus Kinesio Taping to Exercise Alone on Pain, Fatigue, Health Status, Quality of Life, Sleep Quality and Depression in Woman With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to compare the effectiveness of a 6-week core stabilization exercise (CSE) program with and without kinesio taping on pain, fatigue, health status, quality of life, sleep quality and depression in woman with fibromyalgia. Participants were allocated into two groups as CSE and CSE plus kinesio taping group. Pain, fatigue, health status, quality of life, sleep quality and depression were assessed at the baseline and after 6-weeks treatment.
Detailed Description
A 6-weeks prospective randomized controlled trial examined the effects of core stabilization exercise (CSE) plus kinesio taping (KT) compared to CSE alone on pain, fatigue, health status, quality of life, sleep quality and depression in woman with FM. The trial was approved by the Ethics committee of Ankara Yildirim Beyazit University (Approval time and number: 17.01.2018-14). The study was performed in compliance with Helsinki Declaration where applicable. The patient's recruitment started in February 2018. The patients diagnosed with Fibromyalgia according to the criteria of the 1990 American College of Rheumatology participated in the study. Prior to the treatment and after 6-weeks treatment, participants' pain level, fatigue, health status, quality of life (QoL), psychological status and sleep quality were assessed. Assessments were realized by face-to-face interview method.Patients who participated in CSE group performed CSE program alone, whereas patients in CSE+KT group performed CSE program with KT application. The treatment was carried out 2 days a week for 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Exercise, Rheumatic Diseases
Keywords
Fibromyalgia, Exercise, Kinesio Taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Core stabilization exercise group
Arm Type
Active Comparator
Arm Description
Core stabilization exercise (CSE): The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional.
Arm Title
Core stabilization exercise plus kinesio taping group
Arm Type
Experimental
Arm Description
Core stabilization exercise (CSE): The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional. Kinesio Taping: The Kinesio Taping was carried out 2 days a week for 6 weeks (12 sessions) by experienced and certificated physiotherapist. Kinesio taping was applied to spinal region.
Intervention Type
Other
Intervention Name(s)
Core stabilization exercise group
Intervention Description
The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional.
Intervention Type
Other
Intervention Name(s)
Core stabilization exercise plus kinesio taping group
Intervention Description
The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional.
Primary Outcome Measure Information:
Title
Pain level
Description
Pain level was assessed with Visual Analog Scale.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Health Status
Description
Health status of participants were assessed with Turkish version of Fibromyalgia Impact Questionnaire.
Time Frame
Two years
Title
Life Quality
Description
Quality of Life was assessed with Turkish version of Nottingham Health Profile
Time Frame
Two years
Title
Depression
Description
Depression was assessed with Turkish version of Beck Depression Inventory
Time Frame
Two years
Title
Sleep Quality
Description
Sleep quality was assessed with Jenkins Sleep Scale.
Time Frame
Two years
Title
Fatigue
Description
Fatigue was assessed with Visual Analog Scale
Time Frame
Two years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed with Fibromyalgia, being woman, having moderate or severe pain according to Visual Analog Scale, 18-65 years of age and being volunteer for the study Exclusion Criteria: having neurologic, infectious, and endocrine diseases, malignancy, being pregnant, severe psychological disorders, any changing of medications during treatment, being allergic to taping, any condition interfering with exercise (advanced cardiac, respiratory or musculoskeletal problems), and intervention including exercise program or physical therapy in the last 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oğuzhan Mete, PT
Phone
05347409217
Email
fztoguzhanmete06@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oğuzhan Mete, PT
Organizational Affiliation
Research Assistant
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Yildirim Beyazit University
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oğuzhan Mete, PT
Phone
05347409217
Email
fztoguzhanmete06@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Core Stabilization Exercise Plus Kinesio Taping in Woman With Fibromyalgia

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