TY - JOUR
T1 - Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee
AU - Kitay, G. S.
AU - Koren, M. J.
AU - Helfet, D. L.
AU - Parides, M. K.
AU - Markenson, J. A.
N1 - Funding Information:
This study was supported by Kineticure, Inc. Helfet DL and Markenson JA are paid consultants to Kineticure.
PY - 2009/10
Y1 - 2009/10
N2 - Objectives: We evaluated the efficacy of combined mechanical vibrations, continuous passive motion (CPM) and heat on the severity of pain in management of osteoarthritis of the knee (OA-K). Methods: In this controlled, double crossover study, 71 OA-K patients were randomized in Phase 1 to receive 4 weeks active treatment consisting of two 20-min sessions per day (34 patients, Group AB) or treatment with a sham device (37 patients, Group BA). This was followed by a 2-week washout period (Phase 2). In Phase 3, patients crossed over so that Group AB was treated with the sham device and Group BA received active treatment for an additional 4 weeks. Patient assessments of pain (visual analog scale, VAS) and Western Ontario and McMaster Universities (WOMAC) OA index were performed at baseline and at study weeks 2, 4, 6, and 10. Net treatment effects were estimated by comparing outcomes between active and sham treatment study phases. Results: Treatment benefits were noted for both of the trial's two pre-specified primary endpoints, VAS and WOMAC. VAS was reduced at all follow-up time points for patients receiving active treatment compared to sham treatment with a net treatment effect of 14.4 ± 4.1 mm (P = 0.001). Similarly, the WOMAC score was reduced significantly with active treatment at all measured points with a net effect of 8.8 ± 1.9 points (P < 0.001). The secondary endpoints, range of motion (ROM) and treatment satisfaction, also improved with active vs sham treatment. Conclusion: Four weeks treatment with combined CPM, vibration and local heating significantly decreases pain, improves ROM and the quality of life in patients with OA-K (ClinicalTrials.gov registration number: NCT00858416).
AB - Objectives: We evaluated the efficacy of combined mechanical vibrations, continuous passive motion (CPM) and heat on the severity of pain in management of osteoarthritis of the knee (OA-K). Methods: In this controlled, double crossover study, 71 OA-K patients were randomized in Phase 1 to receive 4 weeks active treatment consisting of two 20-min sessions per day (34 patients, Group AB) or treatment with a sham device (37 patients, Group BA). This was followed by a 2-week washout period (Phase 2). In Phase 3, patients crossed over so that Group AB was treated with the sham device and Group BA received active treatment for an additional 4 weeks. Patient assessments of pain (visual analog scale, VAS) and Western Ontario and McMaster Universities (WOMAC) OA index were performed at baseline and at study weeks 2, 4, 6, and 10. Net treatment effects were estimated by comparing outcomes between active and sham treatment study phases. Results: Treatment benefits were noted for both of the trial's two pre-specified primary endpoints, VAS and WOMAC. VAS was reduced at all follow-up time points for patients receiving active treatment compared to sham treatment with a net treatment effect of 14.4 ± 4.1 mm (P = 0.001). Similarly, the WOMAC score was reduced significantly with active treatment at all measured points with a net effect of 8.8 ± 1.9 points (P < 0.001). The secondary endpoints, range of motion (ROM) and treatment satisfaction, also improved with active vs sham treatment. Conclusion: Four weeks treatment with combined CPM, vibration and local heating significantly decreases pain, improves ROM and the quality of life in patients with OA-K (ClinicalTrials.gov registration number: NCT00858416).
KW - Continuous passive motion
KW - Heat therapy
KW - Osteoarthritis
KW - Vibration therapy
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U2 - 10.1016/j.joca.2009.04.015
DO - 10.1016/j.joca.2009.04.015
M3 - Article
C2 - 19433134
AN - SCOPUS:70349248048
SN - 1063-4584
VL - 17
SP - 1269
EP - 1274
JO - Osteoarthritis and Cartilage
JF - Osteoarthritis and Cartilage
IS - 10
ER -