Tai Chi and Physical Therapy for Knee Osteoarthritis

NCT01258985 | Completed Results DMC

• 4 other identifiers: 1R01AT005521-01A1R01AT005521UL1TR000073UL1TR001064
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

We will conduct a large randomized controlled trial comparing the effectiveness and cost-effectiveness of Tai Chi mind-body exercise and standard-of-care Physical Therapy for Knee Osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

Knee; Knee osteoarthritis; osteoarthritis; Knee pain; Tai Chi; Physical Therapy; mind-body exercise

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks

  The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.

  From Week 0 to Week 12

Secondary Outcomes (10)

• Change in Medical Outcomes Short Form-36 PCS

  From Week 0, to Week 12, or to week 24, or to week 52

• Change in 6 Minute Walk

  From Week 0, to Week 12, or to week 24, or to week 52

• Change in 20 Meter Walk Test

  From Week 0, to Week 12, or to week 24, or to week 52

• Change in Patient Global VAS

  From Week 0, to Week 12, or to week 24, or to week 52

• Change in Beck II Depression Inventory

  From Week 0, to Week 12, or to week 24, or to week 52

Study Arms (2)

Tai Chi

ACTIVE COMPARATOR

12 weeks of Tai Chi classes

Behavioral: Tai Chi

Physical Therapy

ACTIVE COMPARATOR

6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Behavioral: Physical Therapy

Interventions

Tai Chi BEHAVIORAL

12 weeks of Tai Chi

Tai Chi

Physical Therapy BEHAVIORAL

6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Physical Therapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 years and older
• American College of Rheumatology criteria for symptomatic Knee OA: Pain on more than half the days of the past month during at least one of the following activities: walking, going up or down stairs, standing upright, or lying in bed at night;101 radiographic evidence of grade I-III tibiofemoral or patellofemoral OA: defined as the presence of osteophytes in the tibiofemoral compartment and /or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views101
• WOMAC pain subscale score \>= 40 (visual analog version) on at least 1 of 5 questions (range 0 to 100 each)
• Clinical examination confirming knee pain or discomfort or instability referable to the knee joint
• Physically able to participate in both the Tai Chi and Standard PT programs
• Willing to undergo testing and intervention procedures and 1.willing to abstain from Tai Chi until completion of the program, if randomized to Standard PT regimen. 2. willing to abstain from Standard PT regimen until completion of the program, if randomized to Tai Chi

You may not qualify if:

• Prior experience with physical therapy, Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi.
• Serious medical conditions limiting the ability and safety to participate in either the Tai Chi or Standard PT regimen programs as determined by primary care physicians; these include dementia, neurological disease, symptomatic heart or vascular disease (angina, peripheral vascular disease, congestive heart failure), severe hypertension, recent stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease, active cancer and anemia
• Any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee
• Any intra-articular Synvisc or Hyalgan injections in the previous 6 months
• Inability to pass the Mini-Mental Status examination (with a score below 24)102
• Inability to walk without a cane or other assistive device 100% of the time during the baseline assessments
• Enrollment in any other clinical trial within the last 30 days
• Plan to permanently relocate from the region during the trial period
• Positive pregnancy test or planning pregnancy within the study period
• Not English-Speaking

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (13)

• Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. doi: 10.1001/archinte.164.5.493.

  PMID: 15006825 BACKGROUND

• Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. doi: 10.1093/rheumatology/keh572. Epub 2005 Mar 1. No abstract available.

  PMID: 15741197 BACKGROUND

• Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302.

  PMID: 18487901 BACKGROUND

• Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54. doi: 10.1056/NEJMoa0912611.

  PMID: 20818876 BACKGROUND

• Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, McAlindon T. Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum. 2009 Nov 15;61(11):1545-53. doi: 10.1002/art.24832.

  PMID: 19877092 BACKGROUND

• Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, Okparavero A, McAlindon T. Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial. BMC Musculoskelet Disord. 2008 Jul 29;9:108. doi: 10.1186/1471-2474-9-108.

  PMID: 18664276 BACKGROUND

• Reid KF, Price LL, Harvey WF, Driban JB, Hau C, Fielding RA, Wang C. Muscle Power Is an Independent Determinant of Pain and Quality of Life in Knee Osteoarthritis. Arthritis Rheumatol. 2015 Dec;67(12):3166-73. doi: 10.1002/art.39336.

  PMID: 26315282 BACKGROUND

• Lee AC, Harvey WF, Price LL, Han X, Driban JB, Iversen MD, Desai SA, Knopp HE, Wang C. Dose-Response Effects of Tai Chi and Physical Therapy Exercise Interventions in Symptomatic Knee Osteoarthritis. PM R. 2018 Jul;10(7):712-723. doi: 10.1016/j.pmrj.2018.01.003. Epub 2018 Jan 31.

  PMID: 29407226 DERIVED

• Lee AC, Harvey WF, Price LL, Han X, Driban JB, Wong JB, Chung M, McAlindon TE, Wang C. Mindfulness Is Associated With Treatment Response From Nonpharmacologic Exercise Interventions in Knee Osteoarthritis. Arch Phys Med Rehabil. 2017 Nov;98(11):2265-2273.e1. doi: 10.1016/j.apmr.2017.04.014. Epub 2017 May 12.

  PMID: 28506776 DERIVED

• Lee AC, Driban JB, Price LL, Harvey WF, Rodday AM, Wang C. Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis. J Pain. 2017 Sep;18(9):1096-1110. doi: 10.1016/j.jpain.2017.05.001. Epub 2017 May 10.

  PMID: 28501708 DERIVED

• Wang C, Schmid CH, Iversen MD, Harvey WF, Fielding RA, Driban JB, Price LL, Wong JB, Reid KF, Rones R, McAlindon T. Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial. Ann Intern Med. 2016 Jul 19;165(2):77-86. doi: 10.7326/M15-2143. Epub 2016 May 17.

  PMID: 27183035 DERIVED

• Driban JB, Morgan N, Price LL, Cook KF, Wang C. Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity. BMC Musculoskelet Disord. 2015 Sep 14;16:253. doi: 10.1186/s12891-015-0715-y.

  PMID: 26369412 DERIVED

• Wang C, Iversen MD, McAlindon T, Harvey WF, Wong JB, Fielding RA, Driban JB, Price LL, Rones R, Gamache T, Schmid CH. Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial. BMC Complement Altern Med. 2014 Sep 8;14:333. doi: 10.1186/1472-6882-14-333.

  PMID: 25199526 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Tai Ji; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Rehabilitation

Results Point of Contact

• Title: chenchen wang
• Organization: Tufts Medical Center

cwang2@tuftsmedicalcenter.org

617-636-3251

Study Officials

• Chenchen Wang, MD, MSc

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 13, 2010
• Study Start: March 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 4, 2016
• Results First Posted: August 4, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)