Effects of Two Different Applications in Fibromyalgia

Sponsor
Biruni University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05897931
Collaborator
(none)
34
2
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Connective tissue massage
  • Other: Kinesio Tape Application
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Connective Tissue Massage and Taping in Patients With Fibromyalgia
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jul 7, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale [4 weeks]

    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

  1. Fibromyalgia Impact Questionnaire [4 weeks]

    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.

  2. McGill Pain Questionnaire [4 weeks]

    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.

  3. Beck's Depression Inventory [4 weeks]

    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. Short Form-36 Quality of Life Scale [4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Biruni University

Investigators

  • Study Chair: Rasmi Muammer, PhD, Yeditepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eylül Pınar KISA, assistant professor, Biruni University
ClinicalTrials.gov Identifier:
NCT05897931
Other Study ID Numbers:
  • Fibromyalgia
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2023