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Connective Tissue Massage With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Connective Tissue Massage
clinical pilates exercises
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:(a) having FM diagnosis according to American College of Rheumatology 2016 criteria, (b) being a women, (c) aged 20-65. (d) being stable in drug use for at least 6 months or more. (e) being volunteer to participate in this study.

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Exclusion Criteria:(a) have been exercising regularly for the past three months, (b) the presence of uncontrolled cardiopulmonary disease, (c) the presence of orthopedic, neurological or mental problems that may prevent exercise, (d) having undergone any surgery in the last six months for both groups, (e) pregnancy, (f) presence of malignancy, (g) not being able to participate in at least 75% of the training.

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Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

Outcomes

Primary Outcome Measures

Pain Location Inventory
Fibromyalgia Impact Questionnaire
Health Assessment Questionnaire
Beck Anxiety Inventory
Short Form-36
Biopsychosocial Questionnaire

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
September 22, 2021
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05063188
Brief Title
Connective Tissue Massage With Fibromyalgia
Official Title
Is Connective Tissue Massage Effective In Individuals With Fibromyalgia?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Intervention group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Connective Tissue Massage
Intervention Description
Connective tissue massage was started from lumbosacral region and continued lower thoracic, scapular, interscapular, and cervical regions, respectively.
Intervention Type
Other
Intervention Name(s)
clinical pilates exercises
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain Location Inventory
Time Frame
10 min
Title
Fibromyalgia Impact Questionnaire
Time Frame
15 min
Title
Health Assessment Questionnaire
Time Frame
10 min
Title
Beck Anxiety Inventory
Time Frame
10 min
Title
Short Form-36
Time Frame
10 min
Title
Biopsychosocial Questionnaire
Time Frame
15 min

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:(a) having FM diagnosis according to American College of Rheumatology 2016 criteria, (b) being a women, (c) aged 20-65. (d) being stable in drug use for at least 6 months or more. (e) being volunteer to participate in this study. - Exclusion Criteria:(a) have been exercising regularly for the past three months, (b) the presence of uncontrolled cardiopulmonary disease, (c) the presence of orthopedic, neurological or mental problems that may prevent exercise, (d) having undergone any surgery in the last six months for both groups, (e) pregnancy, (f) presence of malignancy, (g) not being able to participate in at least 75% of the training. -
Facility Information:
Facility Name
Pamukkale University
City
Pamukkale
State/Province
Denizli
ZIP/Postal Code
20070
Country
Turkey

12. IPD Sharing Statement

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Connective Tissue Massage With Fibromyalgia

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