Early Intervention for Adolescents With Patellofemoral Pain Syndrome

NCT01438762 | Completed

• 1 other identifier: N-20110020
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Anterior Knee Pain

Outcome Measures

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".

  Perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever".

  Baseline, 3, 6, 12 and 24months

Secondary Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score

  Baseline, 3, 6, 12 and 24months

• EQ5D

  Baseline, 3, 6, 12 and 24months

• Neuromuscular function

  Baseline and 3 months

Study Arms (3)

Information and patient education

ACTIVE COMPARATOR

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

Information, education and physiotherapy

ACTIVE COMPARATOR

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

Observational cohort

NO INTERVENTION

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.

Interventions

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.

Also known as: Standard care

Information and patient education

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.

Also known as: Physiotherapy, Multimodal intervention

Information, education and physiotherapy

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mogens Berg Laursen: lead
• University of Southern Denmark: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Orthopaedic Surgery Research Unit, Aalborg Hospital

Aalborg, Aalborg, 9000, Denmark

Location

Related Publications (3)

• 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.

  PMID: 25388552 DERIVED

• 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.

  PMID: 23508216 DERIVED

• 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.

  PMID: 22280484 DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Educational Status; Standard of Care; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Rehabilitation

Study Officials

• Michael S Rathleff

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Administrator

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: September 22, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 24, 2016

Record last verified: 2016-03

Locations

DK (1)