Early Intervention for Adolescents With Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Early Intervention for Adolescents With Patellofemoral Pain Syndrome - a Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438762
• Other study ID #: N-20110020
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: March 23, 2016
• Start date: June 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2016
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Self-reported, unspecific knee pain is highly prevalent among adolescents. A large proportion of the unspecific knee pain can be attributed to Patellofemoral Pain Syndrome (PFPS). There are a number of treatment options for PFPS. Physical therapy has been advocated as one of the cornerstones in rehabilitation of patients with PFPS. Twenty-five years ago, McConnell proposed a multimodal approach that combined several treatment options. The regimen included retraining of the vastus medialis oblique muscle through functional weight bearing activities. This exercise is combined with patellar taping, patellar mobilization, and stretching to improve patellar tracking, reduce pain, and enhance vastus medialis oblique muscle activation. Short term results (<12 months) indicates that multimodal physiotherapy is more effective than placebo treatment.

While treatment for PFPS may be successful for the short-term, long-term results are less promising. A recent review covering the long term prognosis for patients diagnosed with PFPS, reported that only 1/3 of those diagnosed with PFPS and treated conservatively were pain free 12 months after diagnosis. Further ¼ stopped participating in sports because of knee pain.

Predictors of long term outcome (>52weeks) indicate that a long symptom duration, higher age and greater severity at baseline are associated to poorer outcome after treatment. These prognostic factors suggest that an early initiation of treatment might lead to a better long-term prognosis. The purpose of this study is to examine the short and long-term effectiveness of multi-modal physiotherapy compared to standard wait-and-see treatment applied at a very early state of disease among adolescents. The investigators hypothesized a significantly larger proportion of completely recovered patients at three-month follow-up in the interventions group compared to the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• Age 15-19 years

• Insidious onset of anterior knee or retropatellar pain of greater than six weeks' duration

• Provoked by at least two of prolonged sitting or kneeling, squatting, running, hopping, or stair walking

• Tenderness on palpation of the patella, or pain with step down or double leg squat

• Worst pain over the previous week of at least 30 mm on a 100 mm visual analogue scale.

Exclusion criteria:

• Concomitant injury or pain from the hip, lumbar spine, or other knee structures

• Previous knee surgery

• Patellofemoral instability

• Knee joint effusion

• Use of physiotherapy for treating knee pain within the previous year

• Use of weekly use anti-inflammatory drugs.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Behavioral:
• Patient information and education
All subjects will receive one-to-one patient education delivered by a physiotherapist. The information will be standardized and cover the topics of: why does it hurt: pain management; information of how to reduce physical activity if necessary; how to return slowly to sports; how to cope with knee pain and information of how to increase knee alignment during walking and stair walking. The patients will also receive this information in written form. This information is expected to take approximately 45minutes per patient.

Other:
• Information, education and physiotherapy
Patients will receive one-to-one patient education delivered by a physiotherapist. The information will be standardized and cover the topics of: why does it hurt: pain management; information of how to reduce physical activity if necessary; how to return slowly to sports; how to cope with knee pain and information of how to increase knee alignment during walking and stair walking. The patients will also receive this information in written form. In addition the patients will receive supervised multimodal physiotherapy carried out by a physiotherapist with previous experience in treating adolescents and PFPS and has more than two years of practical experience in these areas. The multimodal physiotherapy intervention will be carried out at school premises right after the end of class.

Locations

Country	Name	City	State
Denmark	Orthopaedic Surgery Research Unit, Aalborg Hospital	Aalborg

Sponsors (3)

Lead Sponsor	Collaborator
Mogens Berg Laursen	Aarhus University Hospital, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever".	Perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever".	Baseline, 3, 6, 12 and 24months	No
Secondary	Knee Injury and Osteoarthritis Outcome Score		Baseline, 3, 6, 12 and 24months	No
Secondary	EQ5D		Baseline, 3, 6, 12 and 24months	No
Secondary	Neuromuscular function	Each subjects will undergo quadriceps strength measurements and two basic tests of neuromuscular function of m. vastus medialis and m. vastus lateralis. EMG will be collected during two different conditions: Walking and semi-squat at 90 degrees flexion at the knee joint.	Baseline and 3 months	No