NCT02384603

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

February 18, 2015

Last Update Submit

March 19, 2019

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Visual analogic scale of pain

    11 weeks

Secondary Outcomes (8)

  • McGill Pain Questionnaire

    11 weeks

  • Dolorimetry of the 18 tender points

    11 weeks

  • Survey of Pain Attitudes - brief version

    11 weeks

  • Body posture evaluation

    11 weeks

  • Modified Clinical Test of Sensory Interaction for Balance (CTSIBm)

    11 weeks

  • +3 more secondary outcomes

Study Arms (2)

GPR and CBT

EXPERIMENTAL

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

Other: Global postural reeducationOther: Cognitive behavioral therapy

SMSE and CBT

ACTIVE COMPARATOR

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

Other: Segmental muscle stretching exercisesOther: Cognitive behavioral therapy

Interventions

Global postural reeducationOTHER
GPR and CBT
Segmental muscle stretching exercisesOTHER
SMSE and CBT
Cognitive behavioral therapyOTHER
GPR and CBTSMSE and CBT

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05360-000, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 21769128BACKGROUND

  • 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.

    PMID: 17631737BACKGROUND

  • 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.

    PMID: 21829981BACKGROUND

  • 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.

    PMID: 23098173BACKGROUND

  • Matsutani LA, Sousa do Espirito Santo A, Ciscato M, Yuan SLK, Marques AP. Global posture reeducation compared with segmental muscle stretching exercises in the treatment of fibromyalgia: a randomized controlled trial. Trials. 2023 Jun 7;24(1):384. doi: 10.1186/s13063-023-07422-w.

    PMID: 37280637DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Luciana A Matsutani, MSc

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Amelia P Marques, PhD

    University of Sao Paulo

    STUDY CHAIR

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
PhD student

Study Record Dates

First Submitted

February 18, 2015

First Posted

March 10, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations

BR(1)