Trial record 51 of 130 for:    fibromyalgia | Open Studies | Interventional Studies

Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Sao Paulo General Hospital
Sponsor:
Information provided by (Responsible Party):
Luciana Akemi Matsutani, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02384603
First received: February 18, 2015
Last updated: May 15, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Fibromyalgia
Other: Global postural reeducation
Other: Segmental muscle stretching exercises
Other: Cognitive behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Two Physiotherapeutic Treatments in Pain and Posture of Fibromyalgia Patients: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Visual analogic scale of pain [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • McGill Pain Questionnaire [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Dolorimetry of the 18 tender points [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Survey of Pain Attitudes - brief version [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Body posture evaluation [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Limits of Stability Test (LOS) [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Modified Clinical Test of Sensory Interaction for Balance (CTSIBm) [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Sit-and-Reach Test [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionnaire [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Narrative interview about self-care [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: February 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GPR and CBT
Global postural reeducation associated with cognitive behavioral therapy; 01 session per week for 10 weeks
Other: Global postural reeducation Other: Cognitive behavioral therapy
Active Comparator: SMSE and CBT
Segmental muscle stretching exercises associated with cognitive behavioral therapy; 01 session per week for 10 weeks
Other: Segmental muscle stretching exercises Other: 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.
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02384603

Contacts
Contact: Luciana A Matsutani, MSc 55.11.996977507 la.matsutani@usp.br
Contact: Amelia P Marques, PhD 55.11.30918423 pasqual@usp.br

Locations
Brazil
Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine of the University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 05360-000
Contact: Luciana A Matsutani, MSc    55.11.996977507    la.matsutani@usp.br   
Contact: Amelia P Marques, PhD    55.11.30918423    pasqual@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Luciana A Matsutani, MSc University of Sao Paulo
Study Chair: Amelia P Marques, MSc University of Sao Paulo
  More Information

Publications:
Responsible Party: Luciana Akemi Matsutani, PhD student, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02384603     History of Changes
Other Study ID Numbers: 053/14 
Study First Received: February 18, 2015
Last Updated: May 15, 2016
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 30, 2016