Comparative Effectiveness of versus Physical Therapy for Knee Osteoarthritis: A Randomized, Singleblind Trial Chenchen Wang, Christopher H. Schmid, Maura D Iversen, William F Harvey, Roger A Fielding, Jeffrey B Driban, Lori Lyn Price, John B Wong, Kieran F. Reid, Ramel Rones, Timothy McAlindon DISCLOSURES Funded by the National Center for Complementary and Integrative Health /National Institute of Health (R01 AT005521) Tufts Medical Center/ Tufts University School of Medicine, Boston, USA Knee Osteoarthritis (OA) 1. Helmick CG, et al. Arthritis & Rheum.2008; 58: 15-25. 2. Kotlarz H, et al. Arthritis & Rheum.2009; 60: 3546-3553. Knee OA is the leading cause of disability in the older adults 1 Few remedies effectively treat long-term pain and disability 2 Estimates of direct and indirect medical costs over $185 billion/yr in the US 1 Central Pain Mechanisms in Osteoarthritis PHILLIPS AND CLAUW A & R 2013, 291 302 Physical Therapy (PT) Recommended guidelines of PT for Knee OA includes aerobics and strengthening exercises. Produces moderate benefits for pain and physical functioning. There are limited data on psychological wellbeing and durability of effects. 1. Iversen et al, Am J Nurs 2012, 111:532 537. 2. McAlindon et al, Osteoarthritis and Cartilage. 2014;22:363-88. Factors Contributing to Disability in Knee OA Structural Damage Functional Impairment Self-efficacy Pain Depression/ Anxiety Muscle Weakness Motor impairment 1
Factors contributing to disability in Knee OA Structural Damage Functional Impairment Self-efficacy Pain Disability Depression/ Anxiety Muscle Weakness Motor impairment Potential Mind-body Exercise Benefits for Knee OA Relaxation Function Capacity Pain Reduction Coordination Muscle Strength Flexibility Cardio A traditional Chinese martial art. combines meditation with slow, gentle, graceful movements, deep breathing and relaxation 1 It has physiological and psychosocial benefits for patients with chronic conditions 2 1. Delza, S. Rev. ed.. State University of New York Press Albany, N.Y., 1985. 2. Wang C et al. JAMA Archives of Medicine. 2004;164: 493-501. Study Aim To compare the effectiveness of against a physical-therapy regimen among a large, symptomatic, and radiographic knee OA population with long-term follow up in a clinical setting. Inclusion Criteria Study Design Age 40 or older American College of Rheumatology criteria for knee OA 204 Eligible Patients Duration of Intervention Primary Outcome (2x/week for 12 weeks) Randomized PT (2x/week for 6 weeks, followed by 6 weeks of home exercise). 12 weeks Change in WOMAC Pain from Baseline - 12 weeks 2
Secondary Outcomes - Intervention Classical Yang style Intervention Duration Baseline Weekly WOMAC Week 12 Week 24 Week 52 1 hour, 2x/week, 12 wks 1. WOMAC function 2. Patients Global Assessment 3. Depression (Beck II Inventory) 4. Arthritis Self-efficacy 5. 6 Minute Walk test 6. 20 Meter Walk test 7. Health related quality of life (SF-36) Every session: 1) Warm up and review principles 2) Meditation with movement 3) Breathing technique 4) Relaxation Wang et al. BMC Complement Altern Med. 2014 8;14: doi: 10.1186/1472-6882-14-333. Physical Therapy Consistent with U.S. recommended guidelines for frequency and duration 30-minute outpatient sessions, 2 x /week (6 weeks) Initial Musculoskeletal Exam Personalized therapy to address specific treatment goals Reminded participants to practice daily. Statistical Methods Intent-to-treat Longitudinal models with time and group as categorical fixed factors including their interaction to compare outcomes across all 4 time points. 6 weeks of rigorously monitored exercise, (30-minutes, 4 x /week) home Results 81% (167/204) of participants completed the study intervention and 12 week evaluation 75% (153/204) completed 24 weeks 69% (141/204) completed 52 weeks Percentage of Classes Attended Among all randomized: 69% () vs. 72% (Physical Therapy) Among those who attended at least one class: 74% () vs. 80% (Physical Therapy) Baseline Characteristics (N=204) (n=106) PT (n=98) Age (year) Female 60 (10) 71% 60 (10) 69% Race White Black Asian & others 51 % 39% 11% 54 % 32% 13% Body Mass Index WOMAC-Pain Outcome Expectation 33 (7) 255 (96) 4 (0.5) 33 (7) 253 (101) 4 (0.6) 3
WOMAC Pain 500 450 400 350 300 250 200 150 100 50 Mean WOMAC Pain Scores Intervention Duration TC PT Physical Therapy p=0.16 p=0.06 p=0.38 0 Baseline 12 week 24 week 52 week Change Outcomes from Baseline to 12 Weeks WOMAC-Pain (0-500 mm) WOMAC-Physical Function (0-1700 mm) Patient Global Assessment (0-10 cm) 6 Minute Walk Test (Meters) n=106 PT n=98 95%CI between group -167.2-143.0-24.2 (-57.9, 9.6) -608.3-494.2-114 (-240, 19.6) -3.0-2.2-0.71 (-1.5, 0.02) 28.6 26.1 2.5 (-13.1, 18.0) 20 Meter Walk -1.6-1.1-0.5 (-1.7, 0.7) Beck II - Depression (0-63) Psychological and Quality of Life Outcomes at Week 12 SF-36, Physical Component Summary (0-100) Self-efficacy (1-10) (n=106) PT (n=98) 95%CI between group -2.2 0.5-2.7 (-4.8, -0.7) P=0.008 6.3 3.1 3.2 (0.8, 5.5) P=0.01 1.3 0.8 0.4 (-0.3, 1.2) P=0.22 Medication Pain medication use was generally reduced at all follow-up times (12, 24 and 52 weeks) in both groups. Instructors Effects No differences among 4 instructors in results 4 instructors achieved similar positive outcomes as single instructor in our previous pilot trial Limitations Study was single blinded. Supports generalizability of using this protocol 4
WOMAC Pain ScoreSco WOMAC Pain Score (VAS) Strengths A robust and rigorously conducted randomized comparative-effectiveness trial (two active therapies) designed from mindbody medicine. Large representable study sample of racially diverse participants. Relatively high adherence and follow up rate to both assigned treatment regimens. Conclusion Standardized should be considered as an effective therapeutic option to treat knee OA. The mind-body intervention protocol can be delivered effectively by trained instructors. Acknowledgment 500 300 275 250 225 200 175 150 125 100 75 50 25 0 Mean Weekly WOMAC Pain Scores Attention Control 0 1 2 3 4 5 6 7 8 9 10 11 12 Time (weeks) TaiChi Control -38.5 (-87.2, 10.3) p = 0.0004-157.3 (- 198.5, -116.0) 300 275 250 225 200 175 150 125 100 75 50 25 0 Mean WOMAC Pain Scores Intervention Duration Control P=0.0004 P=0.05 P=0.2 0 12 24 48 Time (weeks) Future for Mind-Body Research: Frame work for studying and testingng Frame work for studying and testing for : Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) PAR-14-182 5
Statistical Methods Longitudinal model with four time points (0, 12, 24, 52 wks) Include fixed effects of treatment, time and their interaction Unstructured covariance matrix to accommodate within-person correlation Fit using restricted maximum likelihood assuming normally distributed errors Assumes data missing at random 6