Clinical trial NCT02384603: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual analogic scale of pain
timeFrame: 11 weeks
Secondary outcomes:
measure: McGill Pain Questionnaire
timeFrame: 11 weeks
measure: Dolorimetry of the 18 tender points
timeFrame: 11 weeks
measure: Survey of Pain Attitudes - brief version
timeFrame: 11 weeks
measure: Body posture evaluation
timeFrame: 11 weeks
measure: Modified Clinical Test of Sensory Interaction for Balance (CTSIBm)
timeFrame: 11 weeks
measure: Sit-and-Reach Test
timeFrame: 11 weeks
measure: Fibromyalgia Impact Questionnaire
timeFrame: 11 weeks
measure: Narrative interview about self-care
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine of the University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Luciana A Matsutani, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Amelia P Marques, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.