Effect of Pulsed Signal Therapy in Patella Chondromalacia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02012413|
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Patella Chondromalacia||Device: PST - Pulsed Signal Therapy Device: Placebo - Sham PST||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Pulsed Signal Therapy in Patella Chondromalacia. Randomized Prospective Trial.|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||December 2015|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|