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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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.
Acronym
Study hypothesis
We hypothesized that pulsed electromagnetic fields associated with exercises are superior than only exercises in the treatment of patellofemoral pain syndrome.
Ethics approval
Federico II University “C. Romano” Ethic committee, 03/02/2010
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Patellofemoral pain syndrome is a common cause of knee pain in young adults, especially in females who practice sport activities.
Intervention
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
Intervention type
Procedure/Surgery
Phase
Drug names
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
01/05/2010
Overall trial end date
31/03/2012
Reason abandoned
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
31
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
7. Infections
8. Rheumatoid arthritis and autoimmune diseases
9. Malignancy
10. Systemic diseases
11. Plateau-patella angle <20° or >30°
Recruitment start date
01/05/2010
Recruitment end date
31/03/2011
Locations
Countries of recruitment
Italy
Trial participating centre
University Hospital Federico II (Azienda Ospedaliera Federico II)
Napoli
80131
Italy
Funders
Funder type
University/education
Funder name
Federico II University (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary