Condition category
Musculoskeletal Diseases
Date applied
26/01/2015
Date assigned
03/02/2015
Last edited
03/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr. Andrea Sambri

ORCID ID

Contact details

Rizzoli Orthopaedic Institute
via Pupilli 1
Bologna
40136
Italy

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

Sponsor information

Organisation

Federico II University

Sponsor details

Corso Umberto I
Naples
80138
Italy

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes