Plain English Summary
Background and study aims
Patellofemoral Pain Syndrome (PFPS) is a common cause of recurrent or chronic knee pain in young adults, affecting the kneecap and cartilage around the joint. It can result in pain at the front of the knee and behind the kneecap. This pain can be severe and sufferers often find it difficult to kneel or squat. Inflammation (swelling) of the knee can also sometimes result with an increase of pro inflammatory cytokines in the synovial (joint) fluid, especially when there is damage to the cartilage at the back of the knee (chondromalacia). The causes are not fully understood but it’s thought likely to be due to a number of factors including imbalances in the muscles surrounding the knee, tight hamstrings , short ligaments and general overuse of the joint. Exercise therapy, including a home exercise program (HEP) has been shown to be of benefit to sufferers of PFPS. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been shown to stimulate cell growth and repair, including in cartilage cells (chondrocytes), and have anti-inflammatory effects. The purpose of this study is to test whether a combination of HEP and PEMFs is better than HEP alone in the treatment of PFPS.
Who can participate?
Participants aged between 15 and 45 and diagnosed with PFPS.
What does the study involve?
Participants are randomly assigned to one of two groups. Those in group 1 are treated with HEP alone. Those in group 2 are given pulsed electromagnetic fields (I-ONE) therapy 4 hours a day for 60 days along with HEP. All participants are then followed up for a year when their knee function and pain levels are assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Federico II Hospital, Naples (Italy)
When is the study starting and how long is it expected to run for?
May 2010 to March 2012
Who is funding the study?
Federico II Hospital, Naples (Italy)
Who is the main contact?
Dr Andrea Sambri
Therapeutic efficacy of pulsed electromagnetic fields in association with home exercise program in the management of patellofemoral pain syndrome: a randomized controlled study at one year follow-up.
We hypothesized that pulsed electromagnetic fields associated with exercises are superior than only exercises in the treatment of patellofemoral pain syndrome.
Federico II University “C. Romano” Ethic committee, 03/02/2010
Randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Patellofemoral pain syndrome is a common cause of knee pain in young adults, especially in females who practice sport activities.
Patients affected by patellofemoral pain syndrome will be randomized:
1. Pulsed electromagnetic fields (I-ONE) therapy 4 hours/day for 60 days associated with home exercise program
2. Only home exercise program
The total duration of follow up will be 1 year
Primary outcome measures
Function of the knee assessed by Victorian Institute of Sport Assessment score (VISA)
Secondary outcome measures
Pain reduction assessed by:
1. Visual analogue scale (VAS)
2. NSAIDs consumption
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. The presence of at least three of the following symptoms: pain when walking up or down stairs, pain when squatting, pain when running, pain when cycling, pain when sitting with knees flexed for a prolonged time, grinding of the patella, and a positive clinical patellar test (such as Clarke’s test or patellar femo-ral grinding test)
2. Untreated pain lasting for more than 3 months
3. Age between 15 and 45 years
4. Informed consent given
Target number of participants
Participant exclusion criteria
1. Knee capsular ligament or meniscus tears
2. Previous knee surgery
3. Severe knee varus/valgus deformities (>10°)
4. Lower limbs prosthesis
5. Corticosteroid therapy
6. B.M.I. > 30 kg/m2
8. Rheumatoid arthritis and autoimmune diseases
10. Systemic diseases
11. Plateau-patella angle <20° or >30°
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Hospital Federico II (Azienda Ospedaliera Federico II)
Federico II University (Italy)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Results - basic reporting