Early Intervention for Adolescents With Patellofemoral Pain Syndrome

• ClinicalTrials.gov Identifier: NCT01438762
• Recruitment Status: Completed
• First Posted: September 22, 2011
• Last Update Posted: March 24, 2016
• Sponsor: Mogens Berg Laursen
• 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: August 2, 2011
• First Posted Date: September 22, 2011
• Last Update Posted Date: March 24, 2016
• Study Start Date: June 2011
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Early Intervention for Adolescents With Patellofemoral Pain Syndrome
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Patellofemoral Pain Syndrome

Intervention

• 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

• 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 *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2011): 102
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2014
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01438762
• Other Study ID Numbers: N-20110020
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mogens Berg Laursen, Northern Orthopaedic Division, Denmark
• Original Responsible Party: Michael Skovdal Rathleff, Northern Orthopaedic Division, Denmark, Physiotherapist, Ph.d student.
• Current Study Sponsor: Mogens Berg Laursen
• Original Study Sponsor: Michael Skovdal Rathleff

Collaborators

• 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 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