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Early Intervention for Adolescents With Patellofemoral Pain Syndrome

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ClinicalTrials.gov Identifier: NCT01438762
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : March 24, 2016
Sponsor:
Collaborators:
University of Southern Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
Mogens Berg Laursen, Northern Orthopaedic Division, Denmark

Tracking Information
First Submitted Date  ICMJE August 2, 2011
First Posted Date  ICMJE September 22, 2011
Last Update Posted Date March 24, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
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 ]
Perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Baseline, 3, 6, 12 and 24months ]
  • EQ5D [ Time Frame: Baseline, 3, 6, 12 and 24months ]
  • Neuromuscular function [ Time Frame: Baseline and 3 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Intervention for Adolescents With Patellofemoral Pain Syndrome
Official Title  ICMJE Early Intervention for Adolescents With Patellofemoral Pain Syndrome - a Cluster Randomized Trial
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Patellofemoral Pain Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Patient information and education
  • 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.

    Intervention: Other: Information, education and physiotherapy
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2011)
102
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01438762
Other Study ID Numbers  ICMJE N-20110020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mogens Berg Laursen, Northern Orthopaedic Division, Denmark
Study Sponsor  ICMJE Mogens Berg Laursen
Collaborators  ICMJE
  • University of Southern Denmark
  • Aarhus University Hospital
Investigators  ICMJE
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
Study Chair: Sten Rasmussen, MD Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
PRS Account Northern Orthopaedic Division, Denmark
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP