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Effect of Pulsed Signal Therapy in Patella Chondromalacia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02012413
First Posted: December 16, 2013
Last Update Posted: April 25, 2017
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.
Information provided by (Responsible Party):
Marco Kawamura Demange, University of Sao Paulo General Hospital
  Purpose
PST (pulsed signal therapy) is a unique form of pulsed electromagnetic field therapy (PEMF) for stimulating healing of damaged structures such as cartilage, bones and soft tissues. The physical effect of the pulsed electromagnetic field (PEMF) has been focus of research in various studies, with cartilage being the most studied, and which has demonstrated an increase in the synthesis of proteoglican and collagen in vitro. This is an randomized, controlled and double blind clinical trial. The main objective is to evaluate clinical improvement regarding anterior knee pain after PST intervention in patients with patellar condropathy.

Condition Intervention
Patella Chondromalacia Device: PST - Pulsed Signal Therapy Device: Placebo - Sham PST

Study Type: Interventional
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.

Further study details as provided by Marco Kawamura Demange, University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 41
Actual Study Start Date: November 2012
Study Completion Date: December 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • PST
  • PEMF
  • Pulsed Eletromagnetic Field
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patellofemoral pain syndrome without tibiofemoral and trochlear chondral degeneration according to magnetic resonance imaging (MRI);
  • presence of patellar chondropathy confirmed by MRI;
  • not having started using direct action drugs on the cartilage in the last 6 months;
  • absence of prior surgery on the studied knee;
  • absence of invasive procedures, such as knee infiltration, in the previous 12 months;
  • absence of disease in the contralateral limb that would cause an excessive burden on the studied limb; and
  • absence of contraindications to performing PST, including a pacemaker, cancer, infectious disease activity, severe heart failure, arrhythmias, angina, epilepsy and pregnancy.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Brazil
Hospital das Clínicas - Universty of São Paulo
Sao Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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
  More Information

Responsible Party: Marco Kawamura Demange, Assistant Professor, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02012413     History of Changes
Other Study ID Numbers: 2012/50167-6
First Submitted: August 8, 2013
First Posted: December 16, 2013
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Marco Kawamura Demange, University of Sao Paulo General Hospital:
knee
chondromalacia
patella
pulsed signal therapy
PST

Additional relevant MeSH terms:
Cartilage Diseases
Chondromalacia Patellae
Musculoskeletal Diseases
Connective Tissue Diseases