Back to resultsEffects of Two Different Applications in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Connective tissue massage
Kinesio Tape Application
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria: Being diagnosed with fibromyalgia. Be in the age range of 20 - 55 years. To be a volunteer participant in the research. Being able to communicate comfortably. To be able to act independently. Exclusion Criteria: Having had a surgical operation within the last year. Presence of significant infection. Being diagnosed with cancer. Being pregnant or breastfeeding. Being addicted to drugs or alcohol. Having a cognitive problem.
Sites / Locations
- Yeditepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Connective tissue massage
Kinesio Tape Application
Arm Description
Participants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Then Connective Tissue Massage will be applied.
Participants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Kinesio tape application will be applied 2 days a week for 4 weeks.
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Visual Analogue Scale (VAS) will be used to assess pain severity. In the assessment, the patient is asked to mark pain intensity on a 10-centimeter line that no pain is 0, and the most severe pain is 10.
Secondary Outcome Measures
Fibromyalgia Impact Questionnaire
The questionnaire assesses the functional status of patients with fibromyalgia. The scale consists of 20 questions that measure physical function, well-being, difficulty in doing work, not being able to go to work, fatigue, stiffness, morning fatigue, pain, anxiety, and depression separately. Low scores indicate improvement or less effect in patients.
McGill Pain Questionnaire
The quality of the pain felt by the patients will be evaluated with the Short Form McGill Pain Questionnaire. The level of severity felt by the patient is evaluated with a number scale (0=no, 1=mild, 2=moderate, 3=severe), and higher scores show severe pain intensity.
Beck's Depression Inventory
The Beck's Depression Inventory (BDI) is a 21-item self-assessment scale that evaluates the patients' perceived depressive symptoms quantitatively and measures the symptoms of depression. The higher scores indicate the severity of the patient's depression. It has been suggested that those who score 17 and above on the BDI may constitute an at-risk group.
Short Form-36 Quality of Life Scale
The scale assesses the quality of life. The scale consists of 36 items evaluated in 8 separate subscales. The score from each subscale is between 0-100, and a higher score indicates better quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05897931
Brief Title
Effects of Two Different Applications in Fibromyalgia
Official Title
Effects of Connective Tissue Massage and Taping in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to determine the effect of connective tissue massage and taping applications on the pain and depression complaints of fibromyalgia patients and to compare their impact on quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connective tissue massage
Arm Type
Experimental
Arm Description
Participants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Then Connective Tissue Massage will be applied.
Arm Title
Kinesio Tape Application
Arm Type
Experimental
Arm Description
Participants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Kinesio tape application will be applied 2 days a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Connective tissue massage
Intervention Description
Connective Tissue Massage will be applied by starting from the lumbosacral region, continuing from the lower thoracic region, and finishing by applying it to the scapular region, interscapular region, and cervico-occipital region.
Intervention Type
Other
Intervention Name(s)
Kinesio Tape Application
Intervention Description
Taping will be applied to the levator scapula and upper trapezius muscles in a "Y" shape, with 25% tension and while the participants were in an upright position. Again in the same position, this time the "C" shaped taping technique will be adhered with 50% tension from the middle fibers of the trapezium to the last rib.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Visual Analogue Scale (VAS) will be used to assess pain severity. In the assessment, the patient is asked to mark pain intensity on a 10-centimeter line that no pain is 0, and the most severe pain is 10.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire
Description
The questionnaire assesses the functional status of patients with fibromyalgia. The scale consists of 20 questions that measure physical function, well-being, difficulty in doing work, not being able to go to work, fatigue, stiffness, morning fatigue, pain, anxiety, and depression separately. Low scores indicate improvement or less effect in patients.
Time Frame
4 weeks
Title
McGill Pain Questionnaire
Description
The quality of the pain felt by the patients will be evaluated with the Short Form McGill Pain Questionnaire. The level of severity felt by the patient is evaluated with a number scale (0=no, 1=mild, 2=moderate, 3=severe), and higher scores show severe pain intensity.
Time Frame
4 weeks
Title
Beck's Depression Inventory
Description
The Beck's Depression Inventory (BDI) is a 21-item self-assessment scale that evaluates the patients' perceived depressive symptoms quantitatively and measures the symptoms of depression. The higher scores indicate the severity of the patient's depression. It has been suggested that those who score 17 and above on the BDI may constitute an at-risk group.
Time Frame
4 weeks
Title
Short Form-36 Quality of Life Scale
Description
The scale assesses the quality of life. The scale consists of 36 items evaluated in 8 separate subscales. The score from each subscale is between 0-100, and a higher score indicates better quality of life.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being diagnosed with fibromyalgia.
Be in the age range of 20 - 55 years.
To be a volunteer participant in the research.
Being able to communicate comfortably.
To be able to act independently.
Exclusion Criteria:
Having had a surgical operation within the last year.
Presence of significant infection.
Being diagnosed with cancer.
Being pregnant or breastfeeding.
Being addicted to drugs or alcohol.
Having a cognitive problem.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmi Muammer, PhD
Organizational Affiliation
Yeditepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Yeditepe University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Two Different Applications in Fibromyalgia
We'll reach out to this number within 24 hrs