Clinical Trial: Effect of Pulsed Signal Therapy in Patella Chondromalacia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Pulsed Signal Therapy in Patella Chondromalacia. Randomized Prospective Trial.

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.

Detailed Summary:

The study was approved by the Research Ethics Committee of the Clinical Hospital (Hospital das Clinicas), University of São Paulo (Universidade de São Paulo - USP) under number 0253/11.

This patient population is estimated to a total of 40 knees, with the patients meeting the following inclusion criteria:

  • aged between 20 and 50 years;
  • male or female;
  • 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.

The presence of patellofemoral pain is identified by anamnesis and physical examination performed by knee surgeons with more than 10 years' experience. The presence of all of the following criteria is required for diagnosis: typical complaint of anterior knee pain with a duration longer than 3 months (when going up or down stairs, squatting, remaining for long periods with bent knees), pain on palpation of the patellar articular surfac
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: 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.


Original Primary Outcome: T2 Mapping MRI Outcome [ Time Frame: 3 month ]

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)



Current Secondary Outcome:

Original Secondary Outcome: Clinical improvement - KOOS [ Time Frame: 6 month ]

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.


Information By: University of Sao Paulo General Hospital

Dates:
Date Received: August 8, 2013
Date Started: November 2012
Date Completion:
Last Updated: April 23, 2017
Last Verified: April 2017