OsteoarthritisNCT01058304
Group Physical Therapy for Knee Osteoarthritis
A study testing Group Physical Therapy for Knee OA and Individual Physical Therapy for Knee OA in people with Osteoarthritis, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Group Physical Therapy for Knee OA and Individual Physical Therapy for Knee OA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physician diagnosis of knee osteoarthritis in VA medical records
- Current knee symptoms
- No PT care for knee osteoarthritis in past 6 months
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center HSR&D COE
Durham, North Carolina, 27705
About this study
Official title: Group Physical Therapy for Veterans With Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Group Physical Therapy for Knee OA, Individual Physical Therapy for Knee OA
- Keywords
- osteoarthritis, knee, physical therapy (specialty), veterans
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Physical Therapy for Knee OAOther
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.
Individual Physical Therapy for Knee OAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Physical Therapy for Knee OA | Experimental | Group Physical Therapy for Knee OA Receives: Other: Group Physical Therapy for Knee OA |
| Individual Physical Therapy for Knee OA | Active comparator | Individual Physical Therapy for Knee OA Receives: Other: Individual Physical Therapy for Knee OA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-weeks, 24-weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kelli Dominick Allen, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058304
- Sponsor's protocol ID
- IIR 09-056
- Status last verified
- Mar 2015
- First submitted
- 26 Jan 2010
- Last updated
- 14 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24647384Allen 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.
PubMed 23279750Zullig 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.
PubMed 24916605Allen 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.
PubMed 30929153
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Physical Therapy for Veterans With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01058304
- Acronym / sponsor ID
- IIR 09-056
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee, physical therapy (specialty), veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Posted 24 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Physical Therapy for Knee OA | Experimental | Other: Group Physical Therapy for Knee OAGroup Physical Therapy for Knee OA |
| Individual Physical Therapy for Knee OA | Active comparator | Other: Individual Physical Therapy for Knee OAIndividual Physical Therapy for Knee OA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Physician diagnosis of knee osteoarthritis in VA medical records
- Current knee symptoms
- No PT care for knee osteoarthritis in past 6 months
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Physical Therapy for Knee OAThe 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. | Other | Group Physical Therapy for Knee OA |
| Individual Physical Therapy for Knee OAThe 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. | Other | Individual Physical Therapy for Knee OA |
Primary outcome
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
Time frame: 12-weeks, 24-weeks
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.
1 secondary outcome
Short Performance Physical Battery (SPPB)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24647384Zullig 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 publication: PubMed 23279750Allen 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 publication: PubMed 24916605Zullig 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.
- Derived from this study: PubMed 30929153Allen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelli Dominick Allen, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Physical Therapy for Knee OA and Individual Physical Therapy for Knee OA in people with Osteoarthritis, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) (time frame: 12-weeks, 24-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058304, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.