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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03997695
• Other study ID #: 14
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: June 2019
• Source: Ankara Yildirim Beyazit University
• Contact: Oguzhan Mete, PT
• Phone: 05347409217
• Email: fztoguzhanmete06[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Collagen Diseases
• Exercise
• Fibromyalgia
• Myofascial Pain Syndromes
• Rheumatic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	Pain level was assessed with Visual Analog Scale.	Two years
Secondary	Health Status	Health status of participants were assessed with Turkish version of Fibromyalgia Impact Questionnaire.	Two years
Secondary	Life Quality	Quality of Life was assessed with Turkish version of Nottingham Health Profile	Two years
Secondary	Depression	Depression was assessed with Turkish version of Beck Depression Inventory	Two years
Secondary	Sleep Quality	Sleep quality was assessed with Jenkins Sleep Scale.	Two years
Secondary	Fatigue	Fatigue was assessed with Visual Analog Scale	Two years