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Effect of Pulsed Signal Therapy in Patella Chondromalacia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco Kawamura Demange, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02012413
First received: August 8, 2013
Last updated: April 23, 2017
Last verified: April 2017
  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: 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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 8, 2013
Last Updated: April 23, 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

ClinicalTrials.gov processed this record on May 25, 2017