Enhancing the Effectiveness of Physical Therapy for People With Knee Osteoarthritis

Exercise therapy (ET) is effective as the first line of treatment for reducing pain and
disability in patients with knee osteoarthritis (OA), but studies show its effects diminish
considerably over time. 'Booster' intervention sessions (periodic face-to-face follow-up
appointments following discharge from supervised therapy designed to review and progress the
patient's home program, troubleshoot problems with the program, etc.) have been recommended
to make beneficial effects endure however this recommendation has not been adequately
tested. There are also indications that manual therapy (MT), manually applied treatment
techniques such as joint mobilization/manipulation, manual traction, soft tissue
manipulations, and passive stretching, when combined with ET, may improve the overall
effectiveness of rehabilitation for reducing pain and disability, and, may significantly
delay or reduce the need for total knee arthroplastic surgery and reduce medication intake
in people with knee OA. However, current published evidence-based treatment guidelines
indicate there is not enough data to make a definitive recommendation regarding the use of
MT with ET in rehabilitation programs. Therefore, the overall aim of the project is to
examine the clinical and cost-effectiveness of utilizing booster sessions in the delivery of
ET, and supplementing ET with MT techniques.The study will be a multi-center,randomized
clinical trial, using a 2 x 2 factorial design (factor 1 = booster vs no booster, factor 2 =
ET alone vs ET + MT). Three hundred subjects (100 per study site) with knee OA will be
randomized to one of the following groups: 1) ET - no booster, 2) ET - with booster, 3) MT +
ET - no booster sessions, 4) MT + ET - with booster sessions. Clinical outcome measures
(WOMAC, knee pain, global rating of change and performance-based measures of function) will
be taken at baseline (prior to randomization), at the completion of the initial therapy
sessions (9 weeks) and at 1 year follow-up. The primary endpoint for clinical outcome will
be the WOMAC at 1 year.For the cost effectiveness analysis, the primary cost outcome will be
osteoarthritis treatment costs from the societal perspective, which will include health
system costs for implementing each intervention, medical/surgical costs (primary, secondary,
and tertiary care costs), and personal costs to participants (travel, non-funded
medications, time off work, and quality-of-life burdens). The primary effectiveness outcome
measure will be quality-adjusted life-years (QALYs), derived using quality of life utilities
from EQ-5D scores. Cost and effectiveness values between interventions will be compared via
incremental cost-effectiveness ratios, yielding incremental costs per QALY gained when a
given intervention is chosen. Secondary analyses will examine cost-effectiveness from health
system and from patient perspectives. Cost and effectiveness data will be obtained at 1 year
and 2 year follow-ups. The 2 year follow-up will be the primary endpoint for the
cost-effectiveness analysis.

Inclusion Criteria:

- 40 years of age or older

- Meet the American College of Rheumatology (ACR) clinical criteria for a diagnosis of
knee OA. The ACR clinical criteria for knee OA includes knee pain plus 3 of the
following 6 criteria:

- age > 50 years,

- morning stiffness of < 30 minutes,

- crepitus on active movement,

- tenderness of the bony margins of the joint,

- bony enlargement of the joint noted on exam,

- lack of palpable warmth of the synovium. Based on this criteria, a subject who is
less than 50 years but has knee pain and 3 of the other 5 criteria would also be
classified as having knee OA.

Exclusion Criteria:

- do not meet the ACR clinical criteria for knee OA,

- are scheduled for total knee arthroplasty (TKA) surgery,

- have undergone TJA surgery on any lower extremity joint,

- exhibit uncontrolled hypertension (i.e. individuals not currently taking medication
for hypertension whose systolic blood pressure is greater than 140 mm Hg or diastolic
blood pressure greater than 90 mm Hg at rest),

- have complaints of low back pain or other lower extremity joint pain that affects
function at the time of recruitment,

- have a history of neurological disorders that would affect lower extremity function
(stroke, peripheral neuropathy, parkinson's disease, multiple sclerosis, etc.),

- are women who are pregnant.