Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial Of Qigong For Treatment Of Fibromyalgia
Brief Summary: Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain and hyperalgesia with a prevalence of 2-4% in the general population; it is often accompanied by fatigue, insomnia, anxiety, depression and other conditions. It is a difficult condition to treat, and only recently have drugs been approved by the FDA specifically for the treatment of this condition (Lyrica was approved in 2007, Duloxetine in 2008). There are now several clinical trials of drugs commonly used to treat neuropathic pain (amitriptyline, gabapentin, pregabalin, acetaminophen/tramadol, duloxetine, minserin) reporting some degree of efficacy in treating fibromyalgia. This efficacy makes it practical to consider fibromyalgia along with other neuropathic pain conditions. However, such drug trials report only partial efficacy in relieving pain and/or other symptoms. Current treatment recommendations indicate the need for a multimodal approach; this includes medical management using appropriate drug therapies, psychological therapies, exercise and complementary approaches. The current proposal is for a randomized controlled trial to compare qigong (a complementary modality) to a wait list control to determine if qigong is a useful complementary therapy for fibromyalgia.

The investigators recently completed a pilot trial in which they examined a specific form of qigong (CFQ Qigong, available locally in Halifax), and observed beneficial effects against pain, fibromyalgia impact, and on quality of life scores; importantly, these benefits were all sustained for 6 months to the end of the trial. On the basis of these preliminary observations, the investigators now propose a controlled trial in which CFQ Qigong is compared to a wait list control group. The latter group will be offered qigong training at the end of the trial, so could really be characterized as a delayed treatment group. The study will consist of a 3-day training period, weekly review of technique sessions for 8 weeks, daily practice for 8 weeks, with assessments at baseline, at 8 weeks following the training and practice, and follow-up assessments at 4 and 6 months. Study outcomes will include: (a) pain (numeric rating scale - pain intensity), (b) impact (fibromyalgia impact questionnaire), (c) quality of life measures (SF-36), (d) patient assessments (patient global impression of change and satisfaction scales), (e) sleep measures (Pittsburgh sleep quality index, actigraphy, sleep diary). In addition to these assessments, the investigators will also conduct qualitative assessments in which participants provide a more open-ended assessment of their health status at these same intervals. The main hypothesis being examined is that CFQ Qigong will produce benefits compared to the wait list group.


Options:
A: Inclusion Criteria:

* Women aged 25 to 75 years of age
* A confirmed diagnosis of FMS by a primary care physician (and rheumatologist if present) using the American College of Rheumatology criteria
* Currently under care for their FMS by a primary care physician or rheumatologist
* Determined to be medically stable by their primary care physician and capable of participation in a supervised program of low to moderate intensity exercise
* Willingness to commit to time and travel requirements of project

Exclusion Criteria:

* Do not fulfill ACR definition of FMS
* Presence of a concurrent condition that limits a person's ability to perform the exercise program (i.e., advanced RA or OA, recent MI)
* History of a positive exercise/stress test, or current cardiovascular, pulmonary, neurological, or renal disease where an exercise program is contraindicated
* Uncontrolled hypertension, diabetes, asthma, or heart failure
* Physician does not want his/her patient to participate for any reason
B: Inclusion Criteria:

* fibromyalgia according to the criteria of the American College of Rheumatology (ACR)

Exclusion Criteria:

* physical or psychological comorbidity that interferes with cognitive-behavioral treatment
* participation in other clinical trials
* other psychological treatments
* pregnancy
* illiteracy
* difficulties with understanding Dutch language
C: Inclusion Criteria:

* Age: 35-65 years.
* Meeting the American College of Rheumatology criteria: widespread pain for more than 3 months, and pain with 4 kg/cm of pressure reported for 11 or more of 18 tender points.
* Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer "no" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q ).
* Not to be engaged in regular physical activity \>20 minutes on \>3 days/week.
* Planning to stay in the same Association during the study.
* Able to ambulate, with or without assistance.
* Able to communicate.
* Informed consent: Must be capable and willing to provide consent.

Exclusion Criteria:

* Acute or terminal illness.
* Myocardial infarction in the past 3 months.
* Not capable to ambulate.
* Unstable cardiovascular disease or other medical condition.
* Upper or lower extremity fracture in the past 3 months.
* Severe dementia (MMSE\<10).
* Unwillingness to either complete the study requirements or to be randomised into control or training group.
* Presence of neuromuscular disease or drugs affecting neuromuscular function.
D: Inclusion Criteria:

* Age greater than or equal to 18 years
* A diagnosis of fibromyalgia according to American College of Rheumatology criteria
* Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity
* Pain medications must have been stable for at least 14 days.
* Ability to follow the protocol (with reference to cognitive and situational conditions, (e.g. stable housing, ability to attend follow-up visits, motivation and commitment to self practice of CFQ Qigong for 45-60 minutes per day).
* Willing and able to give written informed consent

Exclusion Criteria:

* Presence of clinically significant medical disorder on history or physical exam that would compromise the participants' safety in the trial as judged by the study physician
* Already practicing CFQ Qigong on a regular basis
* Unable to commit to 45-60 minutes of CFQ Qigong practice per day

Answer: D