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

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ClinicalTrials.gov Identifier: NCT03997695
Recruitment Status : Unknown
Verified June 2019 by Ankara Yildirim Beyazıt University.
Recruitment status was:  Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ankara Yildirim Beyazıt University

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Exercise Rheumatic Diseases Other: Core stabilization exercise group Other: Core stabilization exercise plus kinesio taping group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Core stabilization exercise group

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.

Other: Core stabilization exercise group
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.

Experimental: Core stabilization exercise plus kinesio taping group

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.

Other: Core stabilization exercise plus kinesio taping group
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 Measures :
  1. Pain level [ Time Frame: Two years ]
    Pain level was assessed with Visual Analog Scale.


Secondary Outcome Measures :
  1. Health Status [ Time Frame: Two years ]
    Health status of participants were assessed with Turkish version of Fibromyalgia Impact Questionnaire.

  2. Life Quality [ Time Frame: Two years ]
    Quality of Life was assessed with Turkish version of Nottingham Health Profile

  3. Depression [ Time Frame: Two years ]
    Depression was assessed with Turkish version of Beck Depression Inventory

  4. Sleep Quality [ Time Frame: Two years ]
    Sleep quality was assessed with Jenkins Sleep Scale.

  5. Fatigue [ Time Frame: Two years ]
    Fatigue was assessed with Visual Analog Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997695


Contacts
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Contact: Oğuzhan Mete, PT 05347409217 fztoguzhanmete06@gmail.com

Locations
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Turkey
Ankara Yildirim Beyazit University Recruiting
Ankara, Turkey, 06010
Contact: Oğuzhan Mete, PT    05347409217    fztoguzhanmete06@gmail.com   
Sponsors and Collaborators
Ankara Yildirim Beyazıt University
Investigators
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Study Chair: Oğuzhan Mete, PT Research Assistant
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Responsible Party: Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier: NCT03997695    
Other Study ID Numbers: 14
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ankara Yildirim Beyazıt University:
Fibromyalgia
Exercise
Kinesio Taping
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Rheumatic Diseases
Collagen Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases