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

June 24, 2019 updated by: Ankara Yildirim Beyazıt University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Recruiting
        • Ankara Yildirim Beyazit University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: Two years
Pain level was assessed with Visual Analog Scale.
Two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Status
Time Frame: Two years
Health status of participants were assessed with Turkish version of Fibromyalgia Impact Questionnaire.
Two years
Life Quality
Time Frame: Two years
Quality of Life was assessed with Turkish version of Nottingham Health Profile
Two years
Depression
Time Frame: Two years
Depression was assessed with Turkish version of Beck Depression Inventory
Two years
Sleep Quality
Time Frame: Two years
Sleep quality was assessed with Jenkins Sleep Scale.
Two years
Fatigue
Time Frame: Two years
Fatigue was assessed with Visual Analog Scale
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Oğuzhan Mete, PT, Research assistant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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