Group Physical Therapy for Knee Osteoarthritis

NCT01058304 | Completed Results

• 1 other identifier: IIR 09-056
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Pain management is a priority for the Department of Veterans Affairs (VA) health care system, and knee osteoarthritis (OA) is a main cause of chronic pain. Veterans who receive care within the VA health care system have higher rates and more severe OA than both the general population of adults and veterans who receive health care elsewhere. Physical therapy (PT) is a primary part of treatment for knee OA, but in the VA health care system PT appointments are a limited resource, and veterans often do not receive enough visits to promote long-term improvements in pain and physical function. New models of delivery, such as the group-based approach examined in this study, are needed to expand PT services in a cost-effective manner.

Conditions

Osteoarthritis

Keywords

osteoarthritis; knee; physical therapy (specialty); veterans

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)

  WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms. Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics.

  12-weeks, 24-weeks

Secondary Outcomes (1)

• Short Performance Physical Battery (SPPB)

  12 weeks

Study Arms (2)

Group Physical Therapy for Knee OA

EXPERIMENTAL

Group Physical Therapy for Knee OA

Other: Group Physical Therapy for Knee OA

Individual Physical Therapy for Knee OA

ACTIVE COMPARATOR

Individual Physical Therapy for Knee OA

Other: Individual Physical Therapy for Knee OA

Interventions

Group Physical Therapy for Knee OA OTHER

The group PT arm will include 6 1 to 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.

Group Physical Therapy for Knee OA

Individual Physical Therapy for Knee OA OTHER

The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.

Individual Physical Therapy for Knee OA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of knee osteoarthritis in VA medical records
• Current knee symptoms
• No PT care for knee osteoarthritis in past 6 months

You may not qualify if:

• Diagnosis of systemic rheumatic disease
• Hospitalized for a stroke, transient ischemic attack, aneurysm, myocardial infarction, coronary artery revascularization, or mental health condition in the past 3 months
• Diagnosis of psychosis
• Diagnosis of dementia
• Current chest pain
• On waiting list for / planning arthroplasty within study period (i.e., next 6 months)
• Resident in nursing home
• Currently participating in another OA-related or lifestyle interventional study
• Knee ligament/meniscus injury (past 1 year)
• Cancer that has spread
• Gout in knees
• Multiple Sclerosis

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Durham VA Medical Center HSR&D COE

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

• Zullig LL, Sanders LL, Shaw RJ, McCant F, Danus S, Bosworth HB. A randomised controlled trial of providing personalised cardiovascular risk information to modify health behaviour. J Telemed Telecare. 2014 Apr;20(3):147-52. doi: 10.1177/1357633X14528446. Epub 2014 Mar 19.

  PMID: 24647384 BACKGROUND

• Allen KD, Bongiorni D, Walker TA, Bartle J, Bosworth HB, Coffman CJ, Datta SK, Edelman D, Hall KS, Hansen G, Jennings C, Lindquist JH, Oddone EZ, Senick MJ, Sizemore JC, St John J, Hoenig H. Group physical therapy for veterans with knee osteoarthritis: study design and methodology. Contemp Clin Trials. 2013 Mar;34(2):296-304. doi: 10.1016/j.cct.2012.12.007. Epub 2012 Dec 30.

  PMID: 23279750 RESULT

• Zullig LL, Bosworth HB, Jeffreys AS, Corsino L, Coffman CJ, Oddone EZ, Yancy WS Jr, Allen KD. The association of comorbid conditions with patient-reported outcomes in Veterans with hip and knee osteoarthritis. Clin Rheumatol. 2015 Aug;34(8):1435-41. doi: 10.1007/s10067-014-2707-y. Epub 2014 Jun 12.

  PMID: 24916605 RESULT

• Allen KD, Lo G, Abbate LM, Floegel TA, Lindquist JH, Coffman C, Oddone EZ, Taylor SS, Hall K. Composite measures of physical activity and pain associate better with functional assessments than pain alone in knee osteoarthritis. Clin Rheumatol. 2019 Aug;38(8):2241-2247. doi: 10.1007/s10067-019-04530-4. Epub 2019 Mar 30.

  PMID: 30929153 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Because the target recruitment goal could not be met, a new sample size target was calculated, with a goal of being able to detect an effect size of 0.35. This translated into a target of n=226, which we exceeded by enrolling n=320.

Results Point of Contact

• Title: Kelli D. Allen
• Organization: Health Services Research & Development, Durham VAMC

kelli.allen@va.gov

919-286-0411

Study Officials

• Kelli Dominick Allen, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: February 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 14, 2015
• Results First Posted: March 24, 2015

Record last verified: 2015-03

Locations

US (1)