Is massage therapy beneficial as a single intervention for adult patients with fibromyalgia concerning pain, pain threshold, fatigue, stiffness, anxiety, depression, sleep and health-related quality of life?
How substantial is the risk of bias of the available clinical trials regarding massage therapy in fibromyalgia patients?
Searches
MEDLINE, SCiELO, EMBASE, ISI (Web of Knowledge), PEDro, SPORTDiscus with Full Text, CINAHL with Full Text, Cochrane e LILACS.
All databases were searched with restriction to English and Portuguese languages and to publication period from 1990.
Types of study to be included
Inclusion criteria: clinical trials, according to the definition of the USA National Institutes of Health (a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions).
Condition or domain being studied
Fibromyalgia is a common rheumatologic disorder characterized by chronic widespread pain and reduced pain threshold, with hyperalgesia and allodynia. Typically, this syndrome is associated with additional symptoms, such as fatigue, morning stiffness and non-restorative sleep, and comorbidities, such as anxiety and depression. It impairs significantly the functional capacity and quality of life.
Participants/ population
Inclusion criteria: adult patients (18 years of age or more) with medical diagnosis of fibromyalgia.
Intervention(s), exposure(s)
Inclusion criteria: massage therapy as a single intervention.
Different types of massage techniques will be compared.
Each type of massage technique will be compared with another technique, a non-intervention control group or a placebo group.
Outcome(s)
Primary outcomes
Pain, pain threshold, fatigue, stiffness, anxiety, depression, sleep and health-related quality of life.
Assessment at baseline, immediately after the end of treatment, short, medium and long-term follow up.
Secondary outcomes
None.
Data extraction, (selection and coding)
Study selection: identification of studies and removal of duplicates will be performed by one researcher. Screening and elegibility assessments will be performed independently by two researchers. Disagreements between the researchers will be resolved by discussion and consensus. If a consensus cannot be reached, a third researcher will decide.
Data colection process: two researchers will extract data of the studies regarding source, methods, participants, outcomes and results, with a standardized form. Disagreements between the researchers will be resolved by discussion and consensus. If a consensus cannot be reached, a third researcher will decide.
Risk of bias (quality) assessment
The Cochrane Collaboration’s tool for assessing risk of bias
Strategy for data synthesis
The studies will be grouped according to type of massage technique applied and a narrative systhesis will be made.
If possible, groups of studies with one type of massage technique will be submitted to quantitative analysis, according to the controls and outcomes mentioned above.
Analysis of subgroups or subsets
Massage technique x another massage technique
Massage technique x non-intervention control group
Massage technique x placebo group
Contact details for further information
Susan Yuan
Rua Cipotanea, 51.
Cidade Universitaria.
CEP: 05360-160.
Sao Paulo, SP
Brasil
susanlkyuan@yahoo.com.br
Organisational affiliation of the review
Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine at the University of Sao Paulo
http://www.fm.usp.br/fofito
Review team
Miss Susan Yuan, Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine at the University of Sao Paulo. Ms Luciana Matsutani, Department of Biological and Health Sciences of the Educational Institute for Osasco Foundation Professor Amelia Marques, Department of Physical Therapy, Speech Therapy and Occupational Therapy of the School of Medicine at the University of Sao Paulo.
Anticipated or actual start date
01 March 2012
Anticipated completion date
01 August 2013
Funding sources/sponsors
Research Laboratory of Clinical Physiotherapy and Electromyography.
Department of Physical Therapy, Speech Therapy and Occupational Therapy.
School of Medicine at the University of Sao Paulo.
Conflicts of interest
None known
Language
English, Portuguese-Brazil
Country
Brazil
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Fibromyalgia; Humans; Massage
Date of registration in PROSPERO
28 September 2012
Date of publication of this revision
28 September 2012
Stage of review at time of this submission
Started
Completed
Preliminary searches
Yes
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Data extraction
Risk of bias (quality) assessment
Data analysis
Prospective meta-analysis
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.
