FibromyalgiaNCT02384603
Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients
A study testing Global postural reeducation, Segmental muscle stretching exercises and Cognitive behavioral therapy in people with Fibromyalgia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Global postural reeducation, Segmental muscle stretching exercises and Cognitive behavioral therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria and the presence of at least 11 of 18 tender points.
Who cannot join
- Presence of joint deformities
- Independent walking disability
- Making another physiotherapeutic treatment at the same time.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine of the University of Sao Paulo
São Paulo, São Paulo, 05360-000
About this study
Official title: Effects of Two Physiotherapeutic Treatments in Pain and Posture of Fibromyalgia Patients: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Global postural reeducation, Segmental muscle stretching exercises, Cognitive behavioral therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global postural reeducationOther
Segmental muscle stretching exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| GPR and CBT | Experimental | Global postural reeducation associated with cognitive behavioral therapy; 01 session per week for 10 weeks Receives: Other: Global postural reeducation; Other: Cognitive behavioral therapy |
| SMSE and CBT | Active comparator | Segmental muscle stretching exercises associated with cognitive behavioral therapy; 01 session per week for 10 weeks Receives: Other: Segmental muscle stretching exercises; Other: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogic scale of pain
Measured: 11 weeks
Secondary outcomes (8)
McGill Pain Questionnaire
Measured: 11 weeks
Dolorimetry of the 18 tender points
Measured: 11 weeks
Survey of Pain Attitudes - brief version
Measured: 11 weeks
Body posture evaluation
Measured: 11 weeks
Modified Clinical Test of Sensory Interaction for Balance (CTSIBm)
Measured: 11 weeks
Sit-and-Reach Test
Measured: 11 weeks
Fibromyalgia Impact Questionnaire
Measured: 11 weeks
Narrative interview about self-care
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana Akemi Matsutani, University of Sao Paulo General Hospital
- Investigators
- Luciana A Matsutani, MSc, Principal investigator, University of Sao PauloAmelia P Marques, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384603
- Sponsor's protocol ID
- 053/14
- Status last verified
- Mar 2019
- First submitted
- 18 Feb 2015
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21769128Matsutani 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.
PubMed 17631737Teodori 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.
PubMed 21829981Campbell 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.
PubMed 23098173Matsutani 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.
PubMed 37280637
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Physiotherapeutic Treatments in Pain and Posture of Fibromyalgia Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02384603
- Acronym / sponsor ID
- 053/14
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPR and CBT | Experimental | Other: Global postural reeducation, Other: Cognitive behavioral therapyGlobal postural reeducation associated with cognitive behavioral therapy; 01 session per week for 10 weeks |
| SMSE and CBT | Active comparator | Other: Segmental muscle stretching exercises, Other: Cognitive behavioral therapySegmental muscle stretching exercises associated with cognitive behavioral therapy; 01 session per week for 10 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria and the presence of at least 11 of 18 tender points.
Key exclusion criteria (3 listed)
- Presence of joint deformities
- Independent walking disability
- Making another physiotherapeutic treatment at the same time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global postural reeducation | Other | GPR and CBT |
| Segmental muscle stretching exercises | Other | SMSE and CBT |
| Cognitive behavioral therapy | Other | GPR and CBT, SMSE and CBT |
Primary outcome
Visual analogic scale of pain
Time frame: 11 weeks
8 secondary outcomes
McGill Pain Questionnaire
Time frame: 11 weeks
Dolorimetry of the 18 tender points
Time frame: 11 weeks
Survey of Pain Attitudes - brief version
Time frame: 11 weeks
Body posture evaluation
Time frame: 11 weeks
Modified Clinical Test of Sensory Interaction for Balance (CTSIBm)
Time frame: 11 weeks
Sit-and-Reach Test
Time frame: 11 weeks
Fibromyalgia Impact Questionnaire
Time frame: 11 weeks
Narrative interview about self-care
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 21769128Schmidt-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.
- Background: PubMed 17631737Matsutani 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.
- Background: PubMed 21829981Teodori 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.
- Background: PubMed 23098173Campbell 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.
- Derived from this study: PubMed 37280637Matsutani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana A Matsutani, MSc principal investigator
University of Sao Paulo
Amelia P Marques, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global postural reeducation, Segmental muscle stretching exercises and Cognitive behavioral therapy in people with Fibromyalgia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogic scale of pain (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384603, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.