Pulsed electromagnetic fields in association with home exercise program in the management of patellofemoral pain syndrome.

ISRCTN	ISRCTN74296451
DOI	https://doi.org/10.1186/ISRCTN74296451
Secondary identifying numbers	N/A

Submission date: 26/01/2015
Registration date: 03/02/2015
Last edited: 03/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr. Andrea Sambri
Scientific

Rizzoli Orthopaedic Institute
via Pupilli 1
Bologna
40136
Italy

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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.
Study objectives	We hypothesized that pulsed electromagnetic fields associated with exercises are superior than only exercises in the treatment of patellofemoral pain syndrome.
Ethics approval(s)	Federico II University “C. Romano” Ethic committee, 03/02/2010
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2010
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	31
Key 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
Key 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°
Date of first enrolment	01/05/2010
Date of final enrolment	31/03/2011

Locations

Countries of recruitment

Italy

Study participating centre

University Hospital Federico II (Azienda Ospedaliera Federico II)

Napoli
80131
Italy

Sponsor information

Federico II University
University/education

Corso Umberto I
Naples
80138
Italy

"ROR"	https://ror.org/05290cv24

Funders

Funder type

University/education

Federico II University (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan