Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02012413 |
| Other study ID # |
2012/50167-6 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
August 8, 2013 |
| Last updated |
April 23, 2017 |
| Start date |
November 2012 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
April 2017 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 surface and pain on
patellar compression (reproducing the patient's complaint).
After inclusion in the study, all of the patients will be instructed (for the duration of
the study) not to use drugs with a direct action on the cartilage (e.g., chondroprotectors,
such as glucosamine and chondroitin) to avoid confounding biases regarding the effects of
the treatments. No patients will be included who had started using these drugs in the
previous 6 months to avoid the initial effect of this treatment being a confounder in terms
of clinical improvement.
The study is designed so that the patient and the orthopedist evaluating the clinical
outcome do not know to which group the patient belongs (i.e., a double-blind study).
After patient inclusion and signing of the terms of free and informed consent, the patients
will be randomized by a computer into 2 equal groups, i.e., the control and PST groups. The
patients with both knees included in the study will receive randomization for the right
knee, and the left will be automatically allocated into the other group. This method was
selected to best demonstrate any differences between groups. The final distribution of
patients into groups will be therefore not equalized.
PST application will be then directed to the patellofemoral joint. The PST application
protocol is as follows: 9 daily 1-hour applications, with 5 in the first week, a break for
the weekend, and 4 more the following week.
The control group patients will be submitted to placebo PST treatment with the same protocol
and the device connected not generating magnetic pulses. The device operates silently, and
it is not possible for the patient to determine whether they are receiving the placebo or
treatment, thus maintaining patient blinding. For patients with both knees included, 9
sessions of the treatment are performed on one side and 9 more sessions of the placebo on
the other.
All of the participants are instructed to maintain their usual level of physical activity.
The Kujala score will be taken after 3, 6 and 12 months in both groups. If superiority of
the PST group is observed, it was decided for ethical reasons that the placebo group should
receive the PST treatment and would again be followed up for 1-year post-treatment, with the
Kujala score ascertained at 3, 6 and 12 months.
A sample of approximately 20 patients in each group was used for an alpha of 5% and beta of
20%. An effect size of 8 to 10 between groups was sought and is considered clinically
significant in terms of Kujala score.
