Early Intervention for Adolescents With Patellofemoral Pain Syndrome

This study has been completed.
Sponsor:
Collaborators:
University of Southern Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
Michael Skovdal Rathleff, Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01438762
First received: August 2, 2011
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Patellofemoral Pain Syndrome
Behavioral: Patient information and education
Other: Information, education and physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Intervention for Adolescents With Patellofemoral Pain Syndrome - a Cluster Randomized Trial

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Change in perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever". [ Time Frame: Baseline, 3, 6, 12 and 24months ] [ Designated as safety issue: No ]
    Perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever".


Secondary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Baseline, 3, 6, 12 and 24months ] [ Designated as safety issue: No ]
  • EQ5D [ Time Frame: Baseline, 3, 6, 12 and 24months ] [ Designated as safety issue: No ]
  • Neuromuscular function [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 102
Study Start Date: June 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438762

Locations
Denmark
Orthopaedic Surgery Research Unit, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Michael Skovdal Rathleff
University of Southern Denmark
Aarhus University Hospital
Investigators
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 Universityhospital
Study Chair: Sten Rasmussen, MD Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
  More Information

No publications provided by Northern Orthopaedic Division, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Skovdal Rathleff, Physiotherapist, Ph.d student., Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01438762     History of Changes
Other Study ID Numbers: N-20110020
Study First Received: August 2, 2011
Last Updated: February 5, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Anterior Knee Pain

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014