Early Intervention for Adolescents With Patellofemoral Pain Syndrome

NCT ID: NCT01438762

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-02-28

Brief Summary

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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 ΒΌ 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

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Conditions

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Patellofemoral Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Patient information and education

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Information, education and physiotherapy

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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Standard care Physiotherapy Multimodal intervention

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Mogens Berg Laursen

OTHER

Sponsor Role lead

Responsible Party

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Mogens Berg Laursen

Administrator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael S Rathleff

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

Ewa M Roos, Ph.d

Role: STUDY_CHAIR

Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark

Jens L Olesen, MD, Ph.d

Role: STUDY_CHAIR

Aalborg University Hospital

Sten Rasmussen, MD

Role: STUDY_CHAIR

Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

Locations

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Orthopaedic Surgery Research Unit, Aalborg Hospital

Aalborg, Aalborg, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 25388552 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23508216 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22280484 (View on PubMed)

Other Identifiers

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N-20110020

Identifier Type: -

Identifier Source: org_study_id

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