Effect of Pulsed Signal Therapy in Patella Chondromalacia
|Patella Chondromalacia||Device: PST - Pulsed Signal Therapy Device: Placebo - Sham PST|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Pulsed Signal Therapy in Patella Chondromalacia. Randomized Prospective Trial.|
- Clinical improvement - Kujala score [ Time Frame: 12 months ]A functional score (Kujala) will be performed before, at 3 months, at 6 months and at one year after PST intervention and placebo.
|Actual Study Start Date:||November 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Active Comparator: PST group
roughly 20 patients will be treated with PST protocol, outcomes will be Kujala score improvement at 3, 6 and 12 months.
Device: PST - Pulsed Signal Therapy
PST application is a painless over-the-skin eletromagnetic field application. 9 sessions of application of electromagnetic therapy - PST - during 60 minutes
Placebo Comparator: Control group
roughly 20 patients will be submitted to a placebo PST protocol, outcomes will be Kujala score improvement at 3, 6 and 12 months.
Device: Placebo - Sham PST
Placebo PST will be performed by applying the same device over the patient knee. The machine is not applying the PST but it appears to be on. In this way, patients are blinded to the intervation.
9 sessions of application of Sham PST - during 60 minutes
Other Name: Placebo
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02012413
|Hospital das Clínicas - Universty of São Paulo|
|Sao Paulo, Brazil, 05403-010|
|Principal Investigator:||Adriana Lucia P Silva, B.Sc., M.Sc.||University of Sao Paulo|
|Principal Investigator:||Riccardo G Gobbi, M.D.||University of Sao Paulo|
|Study Chair:||Gilberto L Camanho, M.D., Ph.D||University of Sao Paulo|
|Study Director:||Marco K Demange, M.D. , Ph.D||University of São Paulo|