NCT06469996

Brief Summary

Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS. At least 30 FMS patients will be included in the study. Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated. CTM will be practiced to study group and foam roller will be practiced to control group.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 14, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 14, 2024

Last Update Submit

June 21, 2024

Conditions

Keywords

FibromyalgiaConnective tissue massageMyofascial releaseFoam roller

Outcome Measures

Primary Outcomes (1)

  • disability

    Fibromyalgia Impact Questionnaire is a scale consisting of 10 questions to assess the health status and physical functionality of an individual diagnosed with FM.

    2 minutes

Secondary Outcomes (2)

  • pain assesment

    1 minute

  • Quality of life assesment

    2 minutes

Study Arms (2)

Connective tissue massage group

EXPERIMENTAL

Connective tissue massage will be applied by an experienced physiotherapist for a total of 12 sessions 2 days a week for 6 weeks. While the patients are in sitting position, starting from the lumbosacral region, the lower thoracic, scapular, interscapular and cervical regions will be included in the treatment respectively.

Other: Connective tissue massage

Self myofascial relaxation group

EXPERIMENTAL

Self myofascial relaxation will be applied using foam roller. The practice will continue two days a week for 6 weeks. Foam roller exercise is performed in the supine position with knees bent, hands locked behind the neck and foam roller is placed between the shoulder blades.

Other: Self myofascial relaxation

Interventions

Connective Tissue Massage will be applied by an experienced physiotherapist for a total of 12 sessions 2 days a week for 6 weeks. While the patients are in sitting position, starting from the lumbosacral region, the lower thoracic, scapular, interscapular and cervical regions will be included in the treatment respectively.

Connective tissue massage group

Self myofascial relaxation will be practiced with foam roller in patients with Fibromyalgia.

Self myofascial relaxation group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a woman
  • Being diagnosed with FMS,
  • Being between the ages of 18-65 and volunteering.

You may not qualify if:

  • Neurological, infectious, endocrine and other inflammatory rheumatic diseases, severe psychological disorders, any condition that prevents exercise (advanced cardiac respiratory or orthopedic problems),
  • Malignancy
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songul

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Firat University

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 24, 2024

Study Start

June 20, 2024

Primary Completion

August 20, 2024

Study Completion

August 30, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations