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Early Intervention for Adolescents With Patellofemoral Pain Syndrome

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Patient information and education
Information, education and physiotherapy
Sponsored by
Mogens Berg Laursen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Anterior Knee Pain

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orthopaedic Surgery Research Unit, Aalborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Information and patient education

Information, education and physiotherapy

Observational cohort

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score
EQ5D
Neuromuscular function
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.

Full Information

First Posted
August 2, 2011
Last Updated
March 23, 2016
Sponsor
Mogens Berg Laursen
Collaborators
University of Southern Denmark, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01438762
Brief Title
Early Intervention for Adolescents With Patellofemoral Pain Syndrome
Official Title
Early Intervention for Adolescents With Patellofemoral Pain Syndrome - a Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mogens Berg Laursen
Collaborators
University of Southern Denmark, Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Anterior Knee Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Information and patient education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Information, education and physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Observational cohort
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient information and education
Other Intervention Name(s)
Standard care
Intervention Description
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
Other
Intervention Name(s)
Information, education and physiotherapy
Other Intervention Name(s)
Physiotherapy, Multimodal intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever".
Description
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
Secondary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score
Time Frame
Baseline, 3, 6, 12 and 24months
Title
EQ5D
Time Frame
Baseline, 3, 6, 12 and 24months
Title
Neuromuscular function
Description
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.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Rathleff
Organizational Affiliation
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ewa M Roos, Ph.d
Organizational Affiliation
Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jens L Olesen, MD, Ph.d
Organizational Affiliation
Aalborg University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sten Rasmussen, MD
Organizational Affiliation
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopaedic Surgery Research Unit, Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25388552
Citation
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.
Results Reference
derived
PubMed Identifier
23508216
Citation
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.
Results Reference
derived
PubMed Identifier
22280484
Citation
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.
Results Reference
derived

Learn more about this trial

Early Intervention for Adolescents With Patellofemoral Pain Syndrome

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