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Group Physical Therapy for Knee Osteoarthritis
This study is ongoing, but not recruiting participants.
Study NCT00642772   Information provided by Department of Veterans Affairs
First Received: March 19, 2008   Last Updated: September 3, 2009   History of Changes

March 19, 2008
September 3, 2009
March 2008
September 2008   (final data collection date for primary outcome measure)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which assesses pain, stiffness, and function [ Time Frame: Baseline and Following 12-Week Intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00642772 on ClinicalTrials.gov Archive Site
 
 
 
Group Physical Therapy for Knee Osteoarthritis
Pilot Study of Group Physical Therapy for Knee Osteoarthritis

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.

Background / Rationale: Osteoarthritis (OA) is the one of the most common chronic conditions among veterans, and over half of VA health care users with OA report being limited in their daily activities because of joint symptoms. Physical therapy and ongoing exercise help to reduce pain and improve physical function. However, the majority of veterans with OA are physically inactive. Furthermore, physical therapy appointments in the VA health care system are a limited resource, with demand often exceeding supply, resulting in long wait periods and a limited number of visits (1 or 2) per patient. Extending physical therapy services to a larger number of veterans with OA, in a cost effective manner, may play a key role in improving outcomes in this large patient group.

Objective: The objective of this pilot study is to perform preliminary evaluation of group-based physical therapy program for veterans with knee OA, in preparation for a larger grant submission. This pilot work will allow us to assess the feasibility of group-based sessions, refine the intervention session components as needed, assess the planned recruitment and enrollment methods, estimate the number of potentially eligible veterans at the Durham VAMC, and conduct sample size and power analyses for a larger clinical trial.

Methods: All participants will be involved in a 12-week group-based physical therapy program, with study measures being obtained at baseline and immediately following program completion. Participants will be Durham VAMC patients with symptomatic knee OA. Our goal is to enroll 20 participants who complete the program and follow-up measures, but we may recruit up to 25 participants total, if some participants drop out of the program before completion. Participants will attend group physical therapy sessions bi-weekly for twelve weeks (total of six visits), with each session lasting approximately one hour. Two study team members, a licensed physical therapist and research assistant with training in exercise for knee OA, will lead each session. The research assistant will lead group exercises, and the physical therapist will assess the progress and monitor for any potential problems or special needs of individual patients. During the first 10-15 minutes of each group session, one study team member will talk with participants about a topic related to OA care, such as joint protection, weight management, joint injections and surgery, and stress management. The remainder of the session will involve group warm-up / stretching exercises, then a series of strengthening exercises tailored for patients with knee OA. Participants will also be instructed to perform stretching exercises daily and strengthening exercises three times total each week. Primary outcome measures will be self-reported pain and function. Statistical analyses will compare pre- and post-intervention pain and function, including effect size calculations to assist with sample size estimates for a larger study.

Impact: This study is significant because it examines a novel health services delivery method for improving outcomes among patients with OA - a highly prevalent condition that is also one of the main causes of pain among veterans. Specifically, this pilot study is a key first step toward examining the efficacy and cost-effectiveness of a method for delivering physical therapy services to a larger number of veterans with OA. This delivery method could also be applied to other common orthopedic and neurologic conditions that require physical therapy service.

 
Interventional
Health Services Research, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Osteoarthritis
Other: Group Physical Therapy
Experimental: Group Physical Therapy Intervention
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
25
December 2009
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00642772
Allen, Kelli - Principal Investigator, Department of Veterans Affairs
SHP 08-180
Department of Veterans Affairs
 
Principal Investigator: Kelli Dominick Allen, PhD Durham VA Medical Center
Department of Veterans Affairs
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP