Please select the arm or intervention descriptions that belong 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: Arm Label: placebo (P); Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: phototherapy (FT); Type: EXPERIMENTAL; Interventions: Radiation: Group Phototherapy | Arm Label: phototherapy+Physical activity (FT+A); Type: EXPERIMENTAL; Interventions: Radiation: Phototherapy + Physical activity | Arm Label: Physical activity (A); Type: EXPERIMENTAL; Interventions: Other: Physical activity | Intervention Type: RADIATION; Name: Group Phototherapy; Assigned to Arm(s): phototherapy (FT) | Intervention Type: RADIATION; Name: Phototherapy + Physical activity; Assigned to Arm(s): phototherapy+Physical activity (FT+A) | Intervention Type: OTHER; Name: Physical activity; Assigned to Arm(s): Physical activity (A) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): placebo (P)
B: Arm Label: Aerobic and flexibility exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Aerobic | Arm Label: Strength, aerobic, and flexibility; Type: EXPERIMENTAL; Interventions: Behavioral: Strength training | Arm Label: Fibromyalgia Self-Help Course; Type: EXPERIMENTAL; Interventions: Behavioral: FSHC | Arm Label: a Combination of ST and FSHC; Type: EXPERIMENTAL; Interventions: Behavioral: Combination | Intervention Type: BEHAVIORAL; Name: Aerobic; Assigned to Arm(s): Aerobic and flexibility exercise | Intervention Type: BEHAVIORAL; Name: Strength training; Assigned to Arm(s): Strength, aerobic, and flexibility | Intervention Type: BEHAVIORAL; Name: Combination; Assigned to Arm(s): a Combination of ST and FSHC | Intervention Type: BEHAVIORAL; Name: FSHC; Assigned to Arm(s): Fibromyalgia Self-Help Course
C: Arm Label: CFQ Qigong training group; Type: ACTIVE_COMPARATOR; Interventions: Other: CFQ Qigong | Intervention Type: OTHER; Name: CFQ Qigong; Assigned to Arm(s): CFQ Qigong training group
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle physical activity (LPA) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Fibromyalgia education | Intervention Type: BEHAVIORAL; Name: Lifestyle physical activity (LPA); Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Fibromyalgia education; Assigned to Arm(s): 2

Answer: C