Multidimensional Diagnostics and Effect of Activity Modification in Young Adolescents With Patellofemoral Pain
Primary Purpose
Patellofemoral Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Temporary activity modification and graded exercises
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- 10-14 years of age
- insidious onset of anterior knee or retro- patellar pain of more than 6 weeks duration
- provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping or stair climbing; tenderness on palpation of the patella, pain when stepping down or double leg squatting
Exclusion Criteria:
- Concomitant injury or pain from the hip, lumbar spine or other knee structures
- previous knee surgery
- self-reported patellofemoral instability
- current use of physiotherapy for treating knee pain
- A diagnosis of other knee conditions that may present as anterior knee pain (Mb. Osgood Schlatter, iliotibial band syndrome, sinding-larsen-Johansson, patella tendinopathy or similar).
Sites / Locations
- Aalborg Universitetshospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Self-reported recovery on 7-point Likert scale
Secondary Outcome Measures
Patellofemoral Osteoarthritis Outcome Score (PFOOS)
Pressure Pain thresholds using handheld allometry and cuff-algometry
Pressure pain thresholds will be measured around the knee, lower leg and forearm to assess local and secondary mechanical hyperalgesia and thus the sensitisation of the central nervous pain system. In addition temporal summation and conditioned pain modulation will be measured using cuff-algometry.
Activity level.
Actigraphs activity monitors will be used to collect data on physical activity level before the intervention and after the intervention.
Isometric strength of the knee and hip.
Isometric strength in knee extension, hip extension and hip abduction will be tested using strap-mounted dynamometry.
Self-reported recovery on 7-point Likert scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02402673
Brief Title
Multidimensional Diagnostics and Effect of Activity Modification in Young Adolescents With Patellofemoral Pain
Official Title
Multidimensional Diagnostics and Effect of Activity Modification in Young Adolescents With Patellofemoral Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Problem: Adolescent patellofemoral pain (PFP) is a major problem worldwide and affects 7% of adolescents. Adolescents with PFP have long-lasting severe pain and low quality of life. Current treatment is ineffective for more than 60% and new treatment approaches are needed.
Solution: A novel multidimensional diagnostic approach combining imaging, physical activity level and pain sensitisation in adolescents with PFP. This approach will enable the identification of adolescents with PFP who benefits from a new treatment strategy using activity modification to reduce loading of the patellofemoral joint and graded exercises to improve loading capacity.
Detailed Description
Participants:
Adolescents will be recruited from a population-based cohort from Aalborg and Copenhagen consisting of a total of 16 public schools. This cohort will allow for recruitment of adolescents with PFP from the following categories 1) adolescents not participating in sport outside school; 2) adolescents involved in sports a minimum of 3 times per week. In addition, a randomly recruited age- and gender-matched pain-free group from the same cohort will be recruited to form a control group.
Protocol:
All adolescents will be requested to complete an online questionnaire on current pain problems. If they report having knee pain they will be telephoned. The telephone interview will collect an anamnesis and the adolescents and their parents will be invited to a clinical examination if they have anterior knee pain with an insidious onset and with duration of more than 6 weeks. If the adolescents are diagnosed with PFP they are invited to participate in the project.
Baseline measurements:
PFP will be diagnosed using eligibility criteria in line with previous clinical trials and commonly accepted criteria. All adolescents with PFP from the cohort will be examined using self-report questionnaires, clinical examination, strength of the hip and knee, MRI and pressure pain thresholds. Pressure pain thresholds will be measured around the knee, lower leg and forearm to assess local and secondary mechanical hyperalgesia and thus the sensitisation of the central nervous pain system. Additionally, cuff-algometry will be used to asses temporal summation of pain during repeated stimuli and conditioned pain modulation. The pain-free control group will be examined using the same measurements. The comparison between adolescents with PFP and the pain-free control group will be used in 1-2 descriptive studies with the main purpose of describing this young population based on self-report questionnaires, MRI-scans, strength of the hip ad knee and pain mechanisms.
Main study:
Adolescents with PFP will be asked to participate in main study which investigates the effect of early activity modification and graded exercises among adolescents with patellofemoral pain.
Using a prospective cohort design the investigators will investigate the effect of a novel treatment strategy aimed at temporary reduction in the loading of the patellofemoral joint by activity modification. After inclusion, the custody holder and the adolescent with PFP will be informed to begin a 4 week activity modification period and avoid all sports activity including school sports. This protocol will cause a temporary reduction in the loading of the patellofemoral joint. At 4 weeks they are instructed to begin a predefined training protocol involving graded exercises. The purpose of the graded exercises is to increase loading capacity of the tissue around the knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Temporary activity modification and graded exercises
Primary Outcome Measure Information:
Title
Self-reported recovery on 7-point Likert scale
Time Frame
12 weeks.
Secondary Outcome Measure Information:
Title
Patellofemoral Osteoarthritis Outcome Score (PFOOS)
Time Frame
4 and 12 weeks and 6 and 12 months.
Title
Pressure Pain thresholds using handheld allometry and cuff-algometry
Description
Pressure pain thresholds will be measured around the knee, lower leg and forearm to assess local and secondary mechanical hyperalgesia and thus the sensitisation of the central nervous pain system. In addition temporal summation and conditioned pain modulation will be measured using cuff-algometry.
Time Frame
4 and 12 weeks.
Title
Activity level.
Description
Actigraphs activity monitors will be used to collect data on physical activity level before the intervention and after the intervention.
Time Frame
Continuously from 0 to 4 week follow-up.
Title
Isometric strength of the knee and hip.
Description
Isometric strength in knee extension, hip extension and hip abduction will be tested using strap-mounted dynamometry.
Time Frame
4 and 12 weeks.
Title
Self-reported recovery on 7-point Likert scale
Time Frame
4 weeks, and 6 and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
10-14 years of age
insidious onset of anterior knee or retro- patellar pain of more than 6 weeks duration
provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping or stair climbing; tenderness on palpation of the patella, pain when stepping down or double leg squatting
Exclusion Criteria:
Concomitant injury or pain from the hip, lumbar spine or other knee structures
previous knee surgery
self-reported patellofemoral instability
current use of physiotherapy for treating knee pain
A diagnosis of other knee conditions that may present as anterior knee pain (Mb. Osgood Schlatter, iliotibial band syndrome, sinding-larsen-Johansson, patella tendinopathy or similar).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Hölmich, Dr.Med
Organizational Affiliation
Sports Orthopedic Research Center - Copenhagen, Arthroscopic Centre Amager, Copenhagen University Hospital, Amager-Hvidovre, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Graven-Nielsen, PhD
Organizational Affiliation
Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristian Thorborg, PhD
Organizational Affiliation
Sports Orthopedic Research Center - Copenhagen, Arthroscopic Centre Amager, Copenhagen University Hospital, Amager-Hvidovre, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg Universitetshospital
City
Aalborg
State/Province
The North Denmark Region
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31095417
Citation
Rathleff MS, Graven-Nielsen T, Holmich P, Winiarski L, Krommes K, Holden S, Thorborg K. Activity Modification and Load Management of Adolescents With Patellofemoral Pain: A Prospective Intervention Study Including 151 Adolescents. Am J Sports Med. 2019 Jun;47(7):1629-1637. doi: 10.1177/0363546519843915. Epub 2019 May 16.
Results Reference
derived
Learn more about this trial
Multidimensional Diagnostics and Effect of Activity Modification in Young Adolescents With Patellofemoral Pain
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