NCT05897931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

29 days

First QC Date

June 1, 2023

Last Update Submit

July 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Fibromyalgia Impact Questionnaire

    4 weeks

  • McGill Pain Questionnaire

    4 weeks

  • Beck's Depression Inventory

    4 weeks

  • Short Form-36 Quality of Life Scale

    4 weeks

Study Arms (2)

Connective tissue massage

EXPERIMENTAL

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

Kinesio Tape Application

EXPERIMENTAL

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

Interventions

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.

Connective tissue massage

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.

Kinesio Tape Application

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Rasmi Muammer, PhD

    Yeditepe University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 9, 2023

Study Start

June 1, 2023

Primary Completion

June 30, 2023

Study Completion

July 7, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations