Qigong For Treatment Of Fibromyalgia
Information source: Capital District Health Authority, Canada
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia Pain
Intervention: CFQ Qigong (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Capital District Health Authority, Canada
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.
Clinical Details
Official title: A Randomized Controlled Trial Of Qigong For Treatment Of Fibromyalgia
Study design: Treatment, Open Label, Single Group Assignment
Primary outcome: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pain Management Unit - CDHA, Halifax, Nova Scotia, Canada
Additional Information
Starting date: August 2009
Last updated: July 14, 2009
|
