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)

•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

>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.

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

Single-blind

Randomized

12 week trial of 8-form Yang style, group Tai chi

Compared to group wellness education

Non-academic, community setting

Design

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

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

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

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

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

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

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

FIQ total and pain outcomes will be mediated by change in ASES (self-efficacy for pain control and symptom control)

Aim 3: Exploratory

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

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

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

Subject Flow

Compliance0

51

01

52

0

7.5 36 7.5 36

Tai Chi ControlF

req

uenc

y

Hours of Intervention

40

45

50

55

60

65

70

Tai ChiEducation

p=0.0002

Aim 1: Primary OutcomeFIQ Total (Adjusted Baselines)

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)

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

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)

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

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

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

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