Patellofemoral Pain SyndromeNCT02402673
Multidimensional Diagnostics and Effect of Activity Modification in Young Adolescents With Patellofemoral Pain
A study testing Temporary activity modification and graded exercises in people with Patellofemoral Pain Syndrome, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Temporary activity modification and graded exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg Universitetshospital
Aalborg, The North Denmark Region, 9000
About this study
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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Temporary activity modification and graded exercises
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary activity modification and graded exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Not described Receives: Other: Temporary activity modification and graded exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported recovery on 7-point Likert scale
Measured: 12 weeks.
Secondary outcomes (5)
Patellofemoral Osteoarthritis Outcome Score (PFOOS)
Measured: 4 and 12 weeks and 6 and 12 months.
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.
Measured: 4 and 12 weeks.
Activity level.
Actigraphs activity monitors will be used to collect data on physical activity level before the intervention and after the intervention.
Measured: Continuously from 0 to 4 week follow-up.
Isometric strength of the knee and hip.
Isometric strength in knee extension, hip extension and hip abduction will be tested using strap-mounted dynamometry.
Measured: 4 and 12 weeks.
Self-reported recovery on 7-point Likert scale
Measured: 4 weeks, and 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Skovdal Rathleff, Aalborg University
- Investigators
- Per Hölmich, Dr.Med, Study chair, Sports Orthopedic Research Center - Copenhagen, Arthroscopic Centre Amager, Copenhagen University Hospital, Amager-Hvidovre, DenmarkThomas Graven-Nielsen, PhD, Study chair, Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, DenmarkKristian Thorborg, PhD, Study chair, Sports Orthopedic Research Center - Copenhagen, Arthroscopic Centre Amager, Copenhagen University Hospital, Amager-Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402673
- Sponsor's protocol ID
- N- 20140100
- Status last verified
- Jan 2018
- First submitted
- 12 Mar 2015
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31095417
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Diagnostics and Effect of Activity Modification in Young Adolescents With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT02402673
- Acronym / sponsor ID
- N- 20140100
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Temporary activity modification and graded exercises |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary activity modification and graded exercises | Other | Intervention |
Primary outcome
Self-reported recovery on 7-point Likert scale
Time frame: 12 weeks.
5 secondary outcomes
Patellofemoral Osteoarthritis Outcome Score (PFOOS)
Time frame: 4 and 12 weeks and 6 and 12 months.
Pressure Pain thresholds using handheld allometry and cuff-algometry
Time frame: 4 and 12 weeks.
Activity level.
Time frame: Continuously from 0 to 4 week follow-up.
Isometric strength of the knee and hip.
Time frame: 4 and 12 weeks.
Self-reported recovery on 7-point Likert scale
Time frame: 4 weeks, and 6 and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Derived from this study: PubMed 31095417Rathleff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hölmich, Dr.Med study chair
Sports Orthopedic Research Center - Copenhagen, Arthroscopic Centre Amager, Copenhagen University Hospital, Amager-Hvidovre, Denmark
Thomas Graven-Nielsen, PhD study chair
Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark
Kristian Thorborg, PhD study chair
Sports Orthopedic Research Center - Copenhagen, Arthroscopic Centre Amager, Copenhagen University Hospital, Amager-Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary activity modification and graded exercises in people with Patellofemoral Pain Syndrome, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported recovery on 7-point Likert scale (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02402673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.