Early Intervention for Adolescents With Patellofemoral Pain Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Behavioral: Patient information and education; Other: Information, education and physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Orthopaedic Surgery Research Unit, Aalborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Information and patient 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.	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 Names: Standard care
Active Comparator: 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. 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.	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.; Other Names: Physiotherapy; Multimodal intervention
No Intervention: Observational cohort; Those who do not wish to participate in the randomization procedure will be followed through an observational cohort. The observational cohort will be followed at the same time-points and they will be asked which treatment they have received.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score		Baseline, 3, 6, 12 and 24months
EQ5D		Baseline, 3, 6, 12 and 24months
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

Collaborators and Investigators

• Sponsor: Mogens Berg Laursen
• Collaborators: Aarhus University Hospital; University of Southern Denmark
• Investigators: Study Chair: Sten Rasmussen, MD, Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark; Principal Investigator: Michael S Rathleff, Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark; Study Chair: Ewa M Roos, Ph.d, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark; Study Chair: Jens L Olesen, MD, Ph.d, Aalborg University Hospital

Publications and helpful links

General Publications

• Rathleff MS, Roos EM, Olesen JL, Rasmussen S. Exercise during school hours when added to patient education improves outcome for 2 years in adolescent patellofemoral pain: a cluster randomised trial. Br J Sports Med. 2015 Mar;49(6):406-12. doi: 10.1136/bjsports-2014-093929. Epub 2014 Nov 11.
• Rathleff MS, Roos EM, Olesen JL, Rasmussen S, Arendt-Nielsen L. Lower mechanical pressure pain thresholds in female adolescents with patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2013 Jun;43(6):414-21. doi: 10.2519/jospt.2013.4383. Epub 2013 Mar 18.
• Rathleff MS, Roos EM, Olesen JL, Rasmussen S. Early intervention for adolescents with patellofemoral pain syndrome--a pragmatic cluster randomised controlled trial. BMC Musculoskelet Disord. 2012 Jan 27;13:9. doi: 10.1186/1471-2474-13-9.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: September 21, 2011
• First Posted (Estimate): September 22, 2011

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Anterior Knee Pain
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: N-20110020