Effects of Two Different Applications in Fibromyalgia

Effects of Connective Tissue Massage and Taping in Patients With Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Connective tissue massage; Other: Kinesio Tape Application

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eylül Pınar Kısa, PhD; Phone Number: 05321307023; Email: ekisa@biruni.edu.tr
• Study Contact Backup: Name: Begüm KARA KAYA, MSc; Phone Number: +905355720021; Email: bkara@biruni.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Yeditepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connective tissue massage; Participants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Then Connective Tissue Massage will be applied.	Other: Connective tissue massage; 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.
Experimental: Kinesio Tape Application; 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.	Other: Kinesio Tape Application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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.	4 weeks
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.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Biruni University
• Investigators: Study Chair: Rasmi Muammer, PhD, Yeditepe University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Fibromyalgia (Alias Study Number)

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