Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis (KC-01)

Kineticure

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis; Knee Pain

Treatments: Device: sham followed by "Kineticure System"; Device: "Kineticure System" followed by sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858416

KC-01

Details and patient eligibility

About

The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion and heat on the severity of pain in management of osteoarthritis of the knee

Enrollment: 71 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of OA of the knee by ACR criteria
• symptoms consistent with radiographic OA grades 2, 3 or 4 by Kellgren and Lawrence criteria
• moderate to severe knee pain (≥35mm on a 100mm visual analog pain scale (VAS)).

Exclusion criteria

• knee or hip surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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71 participants in 2 patient groups

AB

Experimental group

Description:

First active then Sham

Treatment:

Device: "Kineticure System" followed by sham

BA

Sham Comparator group

Description:

First sham then active

Treatment:

Device: sham followed by "Kineticure System"