Clinical trial NCT03997695: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Exercise
Rheumatic Diseases
Keywords: Fibromyalgia
Exercise
Kinesio Taping
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain level
timeFrame: Two years
Secondary outcomes:
measure: Health Status
timeFrame: Two years
measure: Life Quality
timeFrame: Two years
measure: Depression
timeFrame: Two years
measure: Sleep Quality
timeFrame: Two years
measure: Fatigue
timeFrame: Two years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
Study officials:
affiliation: Research Assistant
name: Oğuzhan Mete, PT
role: STUDY_CHAIR
References: