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:

* Meets American College of Rheumatology (ACR) criteria for FM
* Inactive at study entry
* Willing to become more physically active
* Understands and willing to follow study recommendations regarding lifestyle modification
* Able to participate in the study for 2 years
* Agrees to not make any changes to current FM-related treatments

Exclusion Criteria:

* Any comorbidity that may worsen a participant's physical functioning, independent of FM (e.g., significant cardiovascular disease, history of arrhythmias, morbid obesity, autoimmune diseases, uncontrolled or untreated hypertension, significant renal or prostate disease, stroke, seizure disorder, any other significant neurological diseases)
* Significant peripheral neuropathy
* Any current psychiatric disorder that involves a history of psychosis, including schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar disorder, or severe personality disorder. Participants with mood disorder are not excluded.
* Alcohol or substance abuse within the 2 years prior to study entry
* Current suicide risk or suicide attempt within the 2 years prior to study entry
* Severe physical disability that may interfere with physical activity
* Currently participates in structured exercise or plans to participate in an exercise program
* Any investigational medications or devices within 4 weeks prior to study entry
* Any expected life change, such as relocation, within the next 2 years that may prevent study participation
B: Inclusion Criteria:

* 1. Female volunteers who have been diagnosed with fibromyalgia by a rheumatologist.
* 2. Overall body pain average score ≥ 4
* 3. Age range: 18 to 65 years old
* 4. You must be on stable doses of anyone of these fibromyalgia-related medications for at least 4 weeks: cyclobenzaprine, tramadol, gabapentin, pregabalin, amitriptyline, nortriptyline, trazodone, sertraline, fluoxetine, paxil, remeron, venlafaxine and duloxetine.
* 5. Willingness to restrict any change (add or switch or change in the dose) of any fibromyalgia-related medication for 12 weeks.

Exclusion Criteria:

* 1. Volunteers who have long-standing history of diabetes (\> 2 years), or have been diagnosed with any type of peripheral neuropathy.
* 2. Have a prior history of myocardial infarction (heart attack) or unstable angina or other heart arrhythmias.
* 3. Have been diagnosed with multiple sclerosis or any other demyelinating disorder.
* 4. Have planned to undergo an elective surgery over the next 12 weeks.
* 5. Have other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease)
* 6. Are currently pregnant or actively trying to become pregnant
C: 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
D: Inclusion Criteria:

* Patients with aged between 18-75 years-old who meet the diagnostic criteria of fibromyalgia established by the American College of Rheumatology (ACR)

Exclusion Criteria:

* Patients with a diagnosis not based on the ACR criteria
* Those with cognitive impairment or suffering from physical mental/psychiatric limitations
* Severe concurrent rheumatologic illness that impede participation in the study evaluations
* Those who are not expected to live at least 12 months
* Those without schooling.

Answer: C