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

K

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

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"

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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