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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

August 2, 2011
February 5, 2014
June 2011
February 2014   (final data collection date for primary outcome measure)
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".
Same as current
Complete list of historical versions of study NCT01438762 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Patellofemoral Pain Syndrome
  • 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
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
15 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01438762
N-20110020
No
Michael Skovdal Rathleff, Northern Orthopaedic Division, Denmark
Michael Skovdal Rathleff
  • University of Southern Denmark
  • Aarhus University Hospital
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 Universitetshospital
Study Chair: Sten Rasmussen, MD Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Northern Orthopaedic Division, Denmark
February 2014

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