Inclusion Criteria Rationale
Adults between the ages of 21 to 75 A diagnosis of fibromyalgia (FM) is not common in individuals under 21 years. Individuals are generally diagnosed later in life as FM symptoms worsen. FM increases with age, peaking in individuals between 70 to 79 years of age.3 Individuals over 75 years of age are not seen in large numbers in the clinic population and show increased numbers of comorbidities that may have confounded the results of this feasibility study.
Diagnosis of FM by a physician (confirmation by physician or by self-report of name of diagnosing physician and years since diagnosis) Only those individuals who had been diagnosed by a physician were included to establish a confirmed diagnostic baseline for the study.
Stable non-steroidal treatment regimen for 3 months or longer prior to the study period start date Without a stable treatment regimen (i.e., no expected changes in medication and/or dosage during the intervention period), it would not be possible to determine if any effects on pain, sleep, stress, and health-related quality of life were the result of other treatments or the restorative yoga intervention being evaluated.
English speaking/writing This feasibility study did not have the resources necessary to evaluate and accommodate non-English speaking/writing participants.
Exclusion Criteria Rationale
Any physical limitation that prevents the person from doing the required RY postures (e.g., spondylolisthesis or spondylolysis, herniated disc disease) Although many poses can be modified, all participants must be able to do some form of each posture to induce the functional response being sought; numbers of those excluded for this reason were tracked and considered a part of the feasibility calculations for this study.
Currently pregnant Many yoga poses are not safe for pregnant women, and hormones are thought to play a role in the mechanisms of FM; therefore, the hormones present during pregnancy could potentially alter outcomes.
Current diagnosis or history of diagnosis of bipolar disorder or schizophrenia Yoga mindfulness practices may increase the potential for a negative psychological event and thus require instructors skilled in the treatment of these disorders.
Current use of steroids Inflammation is suggested to be involved in the mechanism of FM. By reducing inflammation in the body, the use of steroids has the potential to alter the outcomes for pain and sleep, confounding the results of this study.
Mindfulness or yoga practice 2 or more times per week for 6 months or more within the past 3 years Recent or current mindfulness or yoga practice may confound the study findings.
Table 1: Inclusion and Exclusion Criteria and Rationale.