Fibromyalgia Pain Clinical Trial
Official title:
A Randomized Controlled Trial Of Qigong For Treatment Of Fibromyalgia
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03029845 -
Propranolol for Treating Fibromyalgia Pain
|
Phase 1 |