search
Back to results

Group Physical Therapy for Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis focused on measuring osteoarthritis, knee, physical therapy (specialty), veterans

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Durham VA Medical Center HSR&D COE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Physical Therapy for Knee OA

Individual Physical Therapy for Knee OA

Arm Description

Group Physical Therapy for Knee OA

Individual Physical Therapy for Knee OA

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Short Performance Physical Battery (SPPB)
This battery of objective physical function tests examines participants' balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function. 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.

Full Information

First Posted
January 26, 2010
Last Updated
March 23, 2015
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT01058304
Brief Title
Group Physical Therapy for Knee Osteoarthritis
Official Title
Group Physical Therapy for Veterans With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Knee osteoarthritis (OA) is one of the most common health problems and a leading cause of disability among veterans. Physical therapy (PT) and ongoing exercise are associated with reduced pain and improved physical function among patients with knee OA, yet the majority of veterans with OA are physically inactive. Furthermore, PT services are a limited resource in the VA health care system, with demand exceeding supply. VA patients with knee OA generally receive only one or two PT visits. Prior research indicates this amount of clinical contact time is not sufficient to provide patients with the assessment, instruction, and support needed to adopt and maintain an exercise program, particularly in the context of a chronic pain condition. Therefore development, testing, and implementation of mechanisms to cost-effectively expand PT services for knee OA may play a key role in improving pain and other outcomes in this large group of veterans. This research examines a group-based approach to delivering PT for knee OA, which can extend services to more veterans, for a greater number of sessions per veteran, at lower staffing costs. The objective of this study is to compare the effectiveness of a group-based PT program for knee OA with usual individual PT care for knee OA. This study will be a randomized controlled trial of a 12-week, group-based PT program among N=320 veterans with symptomatic knee OA at the Durham VA Medical Center (VAMC). Participants will be randomly assigned to the group-based PT program or individual PT (usual care). The group PT arm will include 6 1-hour visits (every other week) led by a physical therapist and exercise physiologist or physical therapy assistant, with 8 participants per group. 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. 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. While the individual PT sessions will differ in structure, they will include the same informational, assessment, and therapeutic content as the group sessions. Both groups will be given instructions for the same home exercise program. The primary outcome for this study will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). The secondary outcome will be objectively assessed physical function (Short Physical Performance Test Protocol). These outcomes will be assessed at baseline and 12-week follow-up. The WOMAC will also be assessed via telephone at 24-week follow-up to examine whether any observed intervention effects are maintained. Mixed linear models will be used to compare outcomes for the two study arms. We will also conduct an economic analysis of the group-based PT program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, knee, physical therapy (specialty), veterans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Physical Therapy for Knee OA
Arm Type
Experimental
Arm Description
Group Physical Therapy for Knee OA
Arm Title
Individual Physical Therapy for Knee OA
Arm Type
Active Comparator
Arm Description
Individual Physical Therapy for Knee OA
Intervention Type
Other
Intervention Name(s)
Group Physical Therapy for Knee OA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individual Physical Therapy for Knee OA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
12-weeks, 24-weeks
Secondary Outcome Measure Information:
Title
Short Performance Physical Battery (SPPB)
Description
This battery of objective physical function tests examines participants' balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function. 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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physician diagnosis of knee osteoarthritis in VA medical records Current knee symptoms No PT care for knee osteoarthritis in past 6 months Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli Dominick Allen, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center HSR&D COE
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24647384
Citation
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.
Results Reference
background
PubMed Identifier
23279750
Citation
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.
Results Reference
result
PubMed Identifier
24916605
Citation
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.
Results Reference
result
PubMed Identifier
30929153
Citation
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.
Results Reference
derived

Learn more about this trial

Group Physical Therapy for Knee Osteoarthritis

We'll reach out to this number within 24 hrs