scott d. mist phd, lac k jones, c sherman, f li, r bennett, j fisher ohsu/ori r21 ar5335061-2...
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Simplified Tai chi for Reducing Fibromyalgia
PainScott D. Mist PhD, LAc
K Jones, C Sherman, F Li, R Bennett, J Fisher OHSU/ORI
R21 AR5335061-2 (NIAMS)
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•Fibromyalgia (FM) is diagnosed in 6 to 12 million Americans, primarily women; annual costs exceeding $20 billion
•Multisymptomatic chronic pain illness with significant physical fitness limitations
•Average 40 year old FM patient demonstrates physical fitness scores found in a healthy person in their 8th decade
Wolfe, 1995, Arth Rheum; Wolfe, 1997, Arth Rheum Jones 2010 J MS Pain; Jones 2009 NA Dis ClinCarson, 2010, Pain
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>90 exercise studies in FM have been published to date.
•Most indicate that higher intensity programs, regardless of mode, result in improved physical fitness, but often worsen pain.
•Recently, exercise that employs a mind/body component has been found to be effective in FM.
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Previous research has suggested that Tai chi offers a therapeutic benefit in patients with FM How much are physical fitness variables improved (balance, strength, aerobic conditioning, flexibility)?
What is the mechanism(s) of action of pain reduction?
What is the optimum frequency, intensity, timing and type/mode?
Tai chi Background
Taggart, 2003, Orthop NursWang, 2010, NE J of Med
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Single-blind
Randomized
12 week trial of 8-form Yang style, group Tai chi
Compared to group wellness education
Non-academic, community setting
Design
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Supervised group 8 form Yang style ◦simplified from 24 form◦both static and dynamic
Dose: 90 minutes, twice weekly x 12 weeks15 min warm up45 min Tai chi training15 min break15 min cool-down
Progressive based on mastery and Borg PE scale.
1 Interventionist
Tai chi Intervention
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Supervised group education
Including diagnostic criteria, pacing, problem solving, diet, sleep, pain management, medications, mental health, wellness and lifestyle management.
3 Interventionist: MD, RD/LD, MSW. Same interventionists and curriculum for all 5 waves. Dose: 90 minutes, twice weekly x 12 weeks.
Education Intervention
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Examiners blinded Medications monitored/not washed out Adherence defined as number of classes
attended Enrollment occurred in 5 waves with
randomization by computer generated numbers blocking on age
Tai chi DVD given to all participants after final data collection
Treatment expectations
RCT adherence/monitoring
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40 years of age or older with FM per 1990 ACR Independent ambulators without assistive devices MD clearance for exercise within past 3 months Willingness for random assignment Willing to keep all treatments/meds steady Absence of dyscognition (>3 Pfeiffer Mental Status)
Excluded: Tai chi training within the past 6 months, or exercising > 30 mins/3x weekly for past 3 months
Serious medical conditions that might limit their participation
Planned elective surgery during study period
Inclusion/Exclusion Criteria
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The primary end point was between group differences in change scores on FM symptom severity and physical function (Fibromyalgia Impact Questionnaire [FIQ] total) at the end of 12 weeks.
Aim 1: FIQ Total
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The end point was between group differences in change scores on pain at the end of 12 weeks. Pain was measured with Brief Pain Inventory (BPI severity & interference) and VAS FIQ #15.
Aim 2a: Pain
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Pittsburg Sleep Quality Index - GlobalFIQ symptomsFIQ physical function
Static balance (stork)Dynamic balance (forward reach)Timed- get up and goUpper body flexibility
Aim 2b: FM symptoms and fitness
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FIQ total and pain outcomes will be mediated by change in ASES (self-efficacy for pain control and symptom control)
Aim 3: Exploratory
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Powered off 4 FM exercise studies and 1 Tai Chi study in older adults without FM
Assumption: 80%power to detect 15% between group differences in FIQ
Allow for 20% drop out, final n=96
Intent to treat analyses
Planned Statistical Analyses
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Conditional change score analysis adjusting for centered baseline1
Similar to two group mean comparison t-test
Advantages of method◦ Less artifact of regression to the mean◦ Lessen baseline differences if present◦ Lower Standard Error (More accurate estimate of
treatment effect)
1 Aickin M, The Permanente Journal, Spring 2009
Planned Statistical Analysis
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Age: 54 years (range 40.7 – 74.1) 93% female 96% Caucasian Body mass index: 30.5 2+ Rx for FM (non-narcotic analgesics and anti-
depressants) Symptomatic 18.4 years Approximately half did not work outside the home
despite that fact that 85% had attended or graduated from college
FIQ total of 63.9 pain VAS of 7
No Baseline Differences Between Conditions
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Subject Flow
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Compliance0
51
01
52
0
7.5 36 7.5 36
Tai Chi ControlF
req
uenc
y
Hours of Intervention
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40
45
50
55
60
65
70
Tai ChiEducation
p=0.0002
Aim 1: Primary OutcomeFIQ Total (Adjusted Baselines)
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Pain
Tire
d
Reste
d
Stiff
ness
Anxiou
s
Depre
ssed
-0.5
0
0.5
1
1.5
2
2.5
Tai ChiEducation
p<0.001
FIQ Symptom Items(Adjusted Baseline)
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Back Scratch p=0.410
0.4
0.8
1.2
1.6
2Inches
8 Foot Get Up & Go p<0.0001
-0.4-0.2
00.20.40.60.8
1
Second
s
One Leg Stand p<0.0001
012345678
Second
s
Maximum Reach p<0.0001
0
0.4
0.8
1.2
1.6Inches
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Pain Function Other
-6
-4
-2
0
2
4
6
8
10
Tai ChiEducation
p<0.001
Self-efficacy improved in Tai Chi(Adjusted Baseline)
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Pain Function Other
-6
-4
-2
0
2
4
6
8
10
Tai ChiEducation
p<0.001
Self-efficacy did not moderate pain or FIQ
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12 weeks of supervised group Tai chi improves FM symptoms including pain and fitness
Findings were both clinically and statistically significant FIQ, pain and sleep on PSQI
Replicated Wang’s Tai Chi study and reproduced improvement in FM symptoms
Extending Wang’s work by examining more fitness variables
Discussion
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Single blind vs. double blind
Optimum length of intervention unknown as improvements were seen at endpoints in both Wang’s and our study
Findings may not generalize to men, children or minorities
Tai Chi master-intervention or interventionist?
Potential Limitations
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Longer study to quantify most efficacious dose
Multi-sited trial or multiple interventionists
Laboratory based fitness testing for 1RM, postural stability, V02 max
Laboratory based pain testing such as QST, NFR and neuroimaging
Future Directions
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