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:

* Age 21 years or older.
* Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for FM: (1) a history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist for a minimum duration of 3 months, and (2) pain in 11 or more of 18 specific tender points with moderate or greater tenderness reported upon digital palpation.27
* Fulfills the ACR 2010 diagnostic criteria for FM: (WPI ≥7 AND SS ≥5) OR (WPI 3-6 AND SS ≥9) and does not have a disorder that would otherwise explain the pain28
* Willing to complete the 12-week or 24-week study, including once or twice-a-week exercise sessions.
* Willing to abstain from Tai Chi or other new formalized exercise programs until completion of the study if randomized to the Aerobic Exercise.
* Willing to abstain from Aerobic Exercise or other new formalized exercise programs until completion of the study if randomized to Tai Chi

Exclusion Criteria:

* Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi.
* Dementia, neurological disease, cancer, cardiovascular disease, pulmonary disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the Tai Chi or Aerobic Exercise programs, as determined by the study physicians.
* Any other diagnosed medical condition known to contribute to FM symptomatology that is not under adequate control for the study period such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome.
* Inability to pass the Mini-Mental Status examination (with a score below 24) 29
* Enrollment in any other clinical trial within the last 30 days
* Plan to permanently relocate from the region during the trial period
* Positive urine pregnancy test at baseline or planning pregnancy within the study period
* Not English-Speaking: English is the only language to be used during the exercise training program. Our self-reported outcome measures are obtained from validated English-version questionnaires. In addition, using other languages would likely require separate classes, recruitment and instructors which are beyond our current study scope
B: 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
C: Inclusion Criteria:

* arthritic condition (osteoarthritis, rheumatoid arthritis or fibromyalgia)
* internet access and ability to use computer

Exclusion Criteria:

* active treatment for cancer
* taken small group arthritis self-management program
D: Inclusion Criteria:

* a patient must have been diagnosed with FM according to diagnostic criteria of the American College of Rheumatology
* being 18 years or older and
* having had continuous chronic pain for at least 6 months.

Exclusion Criteria:

* Patients were excluded if they did not agree to participate in the study,
* were suffering from a severe psychiatric or organic disorder, or
* were involved in employment-related legal proceedings related to their FM. Participants in the trial were required to sign an informed consent form.

Answer: B