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Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Global postural reeducation
Segmental muscle stretching exercises
Cognitive behavioral therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria and the presence of at least 11 of 18 tender points.

Exclusion Criteria:

  • Presence of joint deformities
  • Independent walking disability
  • Making another physiotherapeutic treatment at the same time.

Sites / Locations

  • Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine of the University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GPR and CBT

SMSE and CBT

Arm Description

Global postural reeducation associated with cognitive behavioral therapy; 01 session per week for 10 weeks

Segmental muscle stretching exercises associated with cognitive behavioral therapy; 01 session per week for 10 weeks

Outcomes

Primary Outcome Measures

Visual analogic scale of pain

Secondary Outcome Measures

McGill Pain Questionnaire
Dolorimetry of the 18 tender points
Survey of Pain Attitudes - brief version
Body posture evaluation
Modified Clinical Test of Sensory Interaction for Balance (CTSIBm)
Sit-and-Reach Test
Fibromyalgia Impact Questionnaire
Narrative interview about self-care

Full Information

First Posted
February 18, 2015
Last Updated
March 19, 2019
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02384603
Brief Title
Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients
Official Title
Effects of Two Physiotherapeutic Treatments in Pain and Posture of Fibromyalgia Patients: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to compare the effects of two physiotherapeutic treatments of fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and segmental muscle stretching exercises associated with cognitive behavioral therapy.
Detailed Description
Fibromyalgia is characterized mainly by chronic widespread pain. Segmental muscle stretching therapeutic exercises reduce the shortening of myofascial structures and recover the body flexibility. It is indicated for the treatment of chronic pain caused by osteo-myo-articular dysfunction. The pain behavior may be defined as the adoption of body postures and attitudes that a person communicates his/her pain. In this way, the global postural reeducation - a method of muscles chains stretching exercises - could be an important intervention. In addition, negative thoughts and dysfunctional beliefs are usual in situations of chronic pain, compromising the health recovery process. As part of a pain catastrophizing-related therapeutic approach, physiotherapist may help patients with chronic pain to develop positive, realistic and hope attitudes as based on the cognitive behavioral therapy model.

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
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GPR and CBT
Arm Type
Experimental
Arm Description
Global postural reeducation associated with cognitive behavioral therapy; 01 session per week for 10 weeks
Arm Title
SMSE and CBT
Arm Type
Active Comparator
Arm Description
Segmental muscle stretching exercises associated with cognitive behavioral therapy; 01 session per week for 10 weeks
Intervention Type
Other
Intervention Name(s)
Global postural reeducation
Intervention Type
Other
Intervention Name(s)
Segmental muscle stretching exercises
Intervention Type
Other
Intervention Name(s)
Cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Visual analogic scale of pain
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
McGill Pain Questionnaire
Time Frame
11 weeks
Title
Dolorimetry of the 18 tender points
Time Frame
11 weeks
Title
Survey of Pain Attitudes - brief version
Time Frame
11 weeks
Title
Body posture evaluation
Time Frame
11 weeks
Title
Modified Clinical Test of Sensory Interaction for Balance (CTSIBm)
Time Frame
11 weeks
Title
Sit-and-Reach Test
Time Frame
11 weeks
Title
Fibromyalgia Impact Questionnaire
Time Frame
11 weeks
Title
Narrative interview about self-care
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria and the presence of at least 11 of 18 tender points. Exclusion Criteria: Presence of joint deformities Independent walking disability Making another physiotherapeutic treatment at the same time.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana A Matsutani, MSc
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amelia P Marques, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine of the University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05360-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21769128
Citation
Schmidt-Wilcke T, Clauw DJ. Fibromyalgia: from pathophysiology to therapy. Nat Rev Rheumatol. 2011 Jul 19;7(9):518-27. doi: 10.1038/nrrheum.2011.98.
Results Reference
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PubMed Identifier
17631737
Citation
Matsutani LA, Marques AP, Ferreira EA, Assumpcao A, Lage LV, Casarotto RA, Pereira CA. Effectiveness of muscle stretching exercises with and without laser therapy at tender points for patients with fibromyalgia. Clin Exp Rheumatol. 2007 May-Jun;25(3):410-5.
Results Reference
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PubMed Identifier
21829981
Citation
Teodori RM, Negri JR, Cruz MC, Marques AP. Global Postural Re-education: a literature review. Rev Bras Fisioter. 2011 May-Jun;15(3):185-9. English, Portuguese.
Results Reference
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PubMed Identifier
23098173
Citation
Campbell CM, McCauley L, Bounds SC, Mathur VA, Conn L, Simango M, Edwards RR, Fontaine KR. Changes in pain catastrophizing predict later changes in fibromyalgia clinical and experimental pain report: cross-lagged panel analyses of dispositional and situational catastrophizing. Arthritis Res Ther. 2012 Oct 25;14(5):R231. doi: 10.1186/ar4073.
Results Reference
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Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients

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