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Completed

NCT Number: NCT01438762

Early Intervention for Adolescents With Patellofemoral Pain Syndrome

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.

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Key information

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Surgery Research Unit, Aalborg Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient information and education

Behavioral

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

Information, education and physiotherapy

Other

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

Primary outcomes

  1. 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".

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score

    Time frame: Baseline, 3, 6, 12 and 24months

  2. EQ5D

    Time frame: Baseline, 3, 6, 12 and 24months

  3. 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.

Sponsors and collaborators

Lead sponsor

Mogens Berg Laursen

Other

Collaborators

  • Aarhus University Hospital
  • University of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2011
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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