NCT05063188

Brief Summary

The aim of the study was to examine the effectiveness of clinical pilates exercises and connective tissue massage in individuals with Fibromyalgia (FM). 32 women were randomly divided into two groups as intervention (n=15, mean age=48.80±7.48) and control (n=17, mean age=55.64±7.87). While connective tissue massage and clinical pilates exercises were applied to the intervention group, control group were applied only clinical pilates exercises.According to our results, connective tissue massage increased the effectiveness of clinical pilates exercises in individuals with FM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

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

Study Start

First participant enrolled

September 10, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 22, 2021

Last Update Submit

September 22, 2021

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (6)

  • Pain Location Inventory

    10 min

  • Fibromyalgia Impact Questionnaire

    15 min

  • Health Assessment Questionnaire

    10 min

  • Beck Anxiety Inventory

    10 min

  • Short Form-36

    10 min

  • Biopsychosocial Questionnaire

    15 min

Study Arms (2)

Control group

ACTIVE COMPARATOR
Other: clinical pilates exercises

Intervention group

EXPERIMENTAL
Other: Connective Tissue MassageOther: clinical pilates exercises

Interventions

Connective Tissue MassageOTHER

Connective tissue massage was started from lumbosacral region and continued lower thoracic, scapular, interscapular, and cervical regions, respectively.

Intervention group
clinical pilates exercisesOTHER

Exercises were applied 3 times for 6 weeks, a total of 18 sessions. One session consisted of 10 minutes of warm-up, 40 minutes of Clinical Pilates exercises and 10 minutes of cooling down (60 minutes in total).

Control groupIntervention group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Pamukkale, Denizli, 20070, Turkey (Türkiye)

Location

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

September 22, 2021

First Posted

September 30, 2021

Study Start

September 10, 2019

Primary Completion

September 20, 2020

Study Completion

October 15, 2020

Last Updated

September 30, 2021

Record last verified: 2021-09

Locations

TU(1)