NCT00642772

Brief Summary

Osteoarthritis (OA) is a common cause of pain and disability. Physical therapy is a key part of treatment for OA, but VA Medical Centers are often limited in their capacity to provide physical therapy services for veterans with knee OA. The goal of this study is to perform a preliminary work on a group-based physical therapy program for veterans with knee osteoarthritis (OA), in preparation for a larger project. This work will allow us to assess the feasibility of conducting group-based physical therapy program and to plan a larger grant submission based on the findings of this initial study. We hypothesize that the group-based program will be feasible to administer and will result in improved pain and function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 8, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

March 19, 2008

Results QC Date

June 5, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

OsteoarthritisVeteransPhysical TherapyHealth Services Research

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.

    Baseline and Following 12-Week Intervention

Study Arms (1)

Group Physical Therapy

EXPERIMENTAL

12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.

Other: Group Physical Therapy

Interventions

12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program.

Group Physical Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiographic Evidence of Knee Osteoarthritis and a Clinician's Diagnosis
  • Current knee symptoms

You may not qualify if:

  • Presence of other rheumatological conditions (such as rheumatoid arthritis and fibromyalgia) - Other health-related problem that would prevent safe participation in a physical therapy program - Currently undergoing physical therapy for knee OA, participation in another interventional study, scheduled or on waiting list for joint replacement surgery, resident of nursing home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Results Point of Contact

Title
Dr. Kelli Allen
Organization
Center for Health Services Research in Primary Care, Durham VA Medical Center

Study Officials

  • Kelli Dominick Allen, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 25, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2008

Study Completion

December 1, 2009

Last Updated

April 28, 2015

Results First Posted

July 8, 2014

Record last verified: 2015-04

Locations