FibromyalgiaNCT03997695
Effects of Core Stabilization Exercise Plus Kinesio Taping in Woman With Fibromyalgia
A study testing Core stabilization exercise group and Core stabilization exercise plus kinesio taping group in people with Fibromyalgia and Exercise, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Exercise, Rheumatic Diseases
- What is being tested?
- Core stabilization exercise group and Core stabilization exercise plus kinesio taping group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yildirim Beyazit University
Ankara, 06010
Oğuzhan Mete, PT, 05347409217, fztoguzhanmete06@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Fibromyalgia, Exercise, Rheumatic Diseases
- Being tested
- Core stabilization exercise group, Core stabilization exercise plus kinesio taping group
- Keywords
- Fibromyalgia, Exercise, Kinesio Taping
- Medical subject headings
- Fibromyalgia, Motor Activity, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization exercise groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization exercise group | Active comparator | 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. Receives: Other: Core stabilization exercise group |
| Core stabilization exercise plus kinesio taping group | Experimental | 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. Receives: Other: Core stabilization exercise plus kinesio taping group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Pain level was assessed with Visual Analog Scale.
Measured: Two years
Secondary outcomes (5)
Health Status
Health status of participants were assessed with Turkish version of Fibromyalgia Impact Questionnaire.
Measured: Two years
Life Quality
Quality of Life was assessed with Turkish version of Nottingham Health Profile
Measured: Two years
Depression
Depression was assessed with Turkish version of Beck Depression Inventory
Measured: Two years
Sleep Quality
Sleep quality was assessed with Jenkins Sleep Scale.
Measured: Two years
Fatigue
Fatigue was assessed with Visual Analog Scale
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Feb 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oğuzhan Mete, PT, Study chair, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997695
- Sponsor's protocol ID
- 14
- Status last verified
- Jun 2019
- First submitted
- 23 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03997695
- Acronym / sponsor ID
- 14
- Conditions
- Fibromyalgia, Exercise, Rheumatic Diseases
- Keywords
- Fibromyalgia, Exercise, Kinesio Taping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stabilization exercise group | Active comparator | Other: Core stabilization exercise groupCore 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 plus kinesio taping group | Experimental | Other: Core stabilization exercise plus kinesio taping groupCore 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilization exercise groupThe 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 |
| Core stabilization exercise plus kinesio taping groupThe 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 plus kinesio taping group |
Primary outcome
Pain level
Time frame: Two years
Pain level was assessed with Visual Analog Scale.
5 secondary outcomes
Health Status
Time frame: Two years
Life Quality
Time frame: Two years
Depression
Time frame: Two years
Sleep Quality
Time frame: Two years
Fatigue
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oğuzhan Mete, PT study chair
Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercise group and Core stabilization exercise plus kinesio taping group in people with Fibromyalgia and Exercise, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oğuzhan Mete, PT (05347409217, fztoguzhanmete06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.