Efficacy of AposTherapy® in Knee OA
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 45 - 75 |
Updated: | 3/15/2019 |
Start Date: | April 16, 2015 |
End Date: | December 7, 2018 |
A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis
A prospective, interventional, randomized, double-arm clinical evaluation study to examine
the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the
long-term at 12 months post-treatment, with the primary efficacy assessment based on
improvement in knee pain score and improvement in function in patients following diagnosis of
knee osteoarthritis (OA).
the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the
long-term at 12 months post-treatment, with the primary efficacy assessment based on
improvement in knee pain score and improvement in function in patients following diagnosis of
knee osteoarthritis (OA).
Inclusion Criteria:
- Patients suffering from symptomatic unilateral or bilateral knee OA at the medial
compartment for at least six months;
- Fulfilling the ACR clinical criteria;
- Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more
than or equal to grade 2; and,
- Having VAS-Pain ≥ 3, on a scale between 0-10.
- Patients who have a shoe size between US 4 and US 12
Exclusion Criteria:
- Patients suffering from acute septic arthritis.
- Patients who received a corticosteroid injection within 3 months of the study.
- Patients who received hyaluronic acid (HA) injections within 6 months of the study
- Patients suffering from avascular necrosis of the knee.
- Patients with a history of knee buckling or recent knee injury.
- Patients who have had a joint replacement or other major surgery to the knee, hip or
ankle (ipsilateral or contralateral side).
- Patients suffering from neuropathic arthropathy.
- Patients with an increased tendency to fall.
- Patients exhibiting a lack of physical or mental ability to perform or comply with the
study procedure.
- Patients with a history of pathological osteoporotic fracture.
- Patients suffering from symptomatic degenerative arthritis in lower limb joints other
than the knees.
- Patients with referred pain in the knees from primary back or hip joint pain.
- Patients with neurological deficits to the lower extremity (ex. foot drop)
- Patients whose shoe size is less than US 4 and greater than US 12
- Patients who have had arthroscopy within 6 months of the study
- Patients with inflammatory arthropathy
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