Effect of Pulsed Signal Therapy in Patella Chondromalacia

NCT02012413 | Completed

• 1 other identifier: 2012/50167-6
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patella Chondromalacia

Keywords

knee; chondromalacia; patella; pulsed signal therapy; PST

Outcome Measures

Primary Outcomes (1)

• Clinical improvement - Kujala score

  A functional score (Kujala) will be performed before, at 3 months, at 6 months and at one year after PST intervention and placebo.

  12 months

Study Arms (2)

PST group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Interventions

PST - Pulsed Signal Therapy DEVICE

PST application is a painless over-the-skin eletromagnetic field application. 9 sessions of application of electromagnetic therapy - PST - during 60 minutes

Also known as: PST, PEMF, Pulsed Eletromagnetic Field

PST group

Placebo - Sham PST DEVICE

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

Also known as: Placebo

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas - Universty of São Paulo

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Chondromalacia Patellae; Cartilage Diseases; Patella Fracture

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Knee Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Adriana Lucia P Silva, B.Sc., M.Sc.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Riccardo G Gobbi, M.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Gilberto L Camanho, M.D., Ph.D

  University of Sao Paulo

  STUDY CHAIR

• Marco K Demange, M.D., Ph.D

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: December 16, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

BR (1)