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Effect of Pulsed Signal Therapy in Patella Chondromalacia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Sao Paulo General Hospital
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: December 9, 2013
Last verified: December 2013
  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. A T2 MAP diagram MRI is considered a method in evaluating the indirect biochemical quantity of articular cartilage which may traduce functional behavior of the articular cartilage. This is an randomized, control and double blind clinical trial. The main objective is to evaluate in vivo the effect of PST on patella cartilage in patients with chondromalacia through the T2 MAP diagramed MERI technique. The secondary objective is to evaluate clinical improvement regarding anterior knee pain after PST intervention.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • T2 Mapping MRI Outcome [ Time Frame: 3 month ] [ Designated as safety issue: No ]

    T2 Mapping MRI analyses will be performed before and three-month after PST intervention.

    Three consecutive slices of the T2 map; assessment of T2 values (T2 relaxation times - unit: ms)



Secondary Outcome Measures:
  • Clinical improvement - KOOS [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    A functional score (KOOS) and visual analog scale for pain evaluation will be performed before, at 1 month, at 3 month, at 6 month and at one year after PST intervention.


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PST group
20 patients will do a pre teatment MRI, then will be treated with PST plus physiotherapy, and repeat the MRI after 3 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
20 patients will do MRI after treatment, these patients wil be treat with PST-placebo plus physiotherapy, after 3 months will do MRI
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

Detailed Description:

PST is a proprietary pulsed electromagnetic field therapy protocol.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with patella femoral syndrome
  • patients without previous surgery
  • patients without any disease in the other leg
  • patients without contraindications for PST use

Exclusion Criteria:

  • pantients who abandonment the treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012413

Contacts
Contact: Tania Fernandes, B.A. +55-11-976-515-344 taniafernanda@terra.com.br

Locations
Brazil
Hospital das Clínicas - Universty of São Paulo Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Tania Fernandes, B.A.       taniafernanda@terra.com.br   
Principal Investigator: Marco K Demange, M.D., Ph.D.         
Principal Investigator: Riccardo G Gobbi, M.D.         
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

No publications provided

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: December 9, 2013
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 29, 2014