The recruitment started in 2010 and data collection was completed at all sites (Gothenburg, Stockholm, and Linköping) in 2013. Inclusion criteria were women aged 20–65 years, meeting the American College of Rheumatology (ACR) 1990 classification criteria for FM [6 (link)]. Comorbidity as an exclusion criterion was defined by anamnesis. Exclusion criteria were high blood pressure (>160/90 mmHg), osteoarthritis (OA) in hip or knee, confirmed by radiological findings and affecting activities of daily life such as stair climbing or walking, other severe somatic or psychiatric disorders, other dominating causes of pain than FM, high consumption of alcohol (alcohol use disorders identification test (AUDIT) score >6) [32 (link)], participation in a rehabilitation program within the past year, regular resistance exercise or relaxation exercise twice a week or more, inability to understand or speak Swedish, and not being able to refrain from analgesics, non-steroidal anti-inflammatory drugs (NSAID) or hypnotic drugs for 48 hours prior to examinations.
Women with FM were recruited by newspaper advertisement in the local newspapers of three cities in Sweden (Gothenburg, Stockholm, and Linköping). A total of 402 women with FM who notified their interest for participation in the study were telephone screened for possible eligibility and informed about the study procedure. Out of these, 177 women who were interested in participation were referred for medical examination for further enrollment, while 225 were not eligible for enrollment (for details see Fig.1 ). The 177 women were screened for eligibility by an experienced physician to verify ACR 1990 criteria for FM by means of a standardized interview and palpation of tender points [6 (link)]. A total of 47 women were found not eligible due to not meeting the inclusion criteria (n = 28), or declining participation (n = 19). One-hundred and thirty women with FM fulfilled the inclusion criteria. They were given written and oral information and were referred for baseline examinations (Fig. 1 ). Informed written consent was obtained from all participants before the baseline examination. After completing baseline examinations, the participants were randomized and informed of group allocation. An appointment for an individual introductory meeting with the specific physiotherapist guiding each intervention was scheduled with each participant. The study was approved for all sites by the Regional ethics committee in Stockholm (2010/1121-31/3).![]()
Women with FM were recruited by newspaper advertisement in the local newspapers of three cities in Sweden (Gothenburg, Stockholm, and Linköping). A total of 402 women with FM who notified their interest for participation in the study were telephone screened for possible eligibility and informed about the study procedure. Out of these, 177 women who were interested in participation were referred for medical examination for further enrollment, while 225 were not eligible for enrollment (for details see Fig.
Consolidated Standards of Reporting Trials (CONSORT) flow diagram of the progress of the two groups of the randomized trial. FM fibromyalgia
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