Patellofemoral Pain SyndromeNCT01438762
Early Intervention for Adolescents With Patellofemoral Pain Syndrome
A study testing Patient information and education and Information, education and physiotherapy in people with Patellofemoral Pain Syndrome, run by Mogens Berg Laursen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Patient information and education and Information, education and physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Feb 2014
- 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 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Surgery Research Unit, Aalborg Hospital
Aalborg, Aalborg, 9000
About this study
Official title: Early Intervention for Adolescents With Patellofemoral Pain Syndrome - a Cluster Randomized Trial
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
- Being tested
- Patient information and education, Information, education and physiotherapy
- Keywords
- Anterior Knee Pain
- 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.
Patient information and educationBehavioural
Also called Standard care
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 physiotherapyOther
Also called Physiotherapy, Multimodal intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline, 3, 6, 12 and 24months
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score
Measured: Baseline, 3, 6, 12 and 24months
EQ5D
Measured: Baseline, 3, 6, 12 and 24months
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mogens Berg Laursen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Mogens Berg Laursen, Northern Orthopaedic Division, Denmark
- Investigators
- Michael S Rathleff, Principal investigator, Orthopaedic Surgery Research Unit, Aalborg University Hospital, DenmarkEwa M Roos, Ph.d, Study chair, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, DenmarkJens L Olesen, MD, Ph.d, Study chair, Aalborg University HospitalSten Rasmussen, MD, Study chair, Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438762
- Sponsor's protocol ID
- N-20110020
- Status last verified
- Mar 2016
- First submitted
- 2 Aug 2011
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25388552Rathleff 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.
PubMed 23508216Rathleff 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.
PubMed 22280484
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Adolescents With Patellofemoral Pain Syndrome - a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01438762
- Acronym / sponsor ID
- N-20110020
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Anterior Knee Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mogens Berg LaursenUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Aarhus University Hospital
- Study start
- Jun 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Sep 2011 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Information and patient education | Active comparator | Behavioral: Patient information and educationAll 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 | Active comparator | Other: Information, education and physiotherapyPatients 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. |
| 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. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Patient information and educationAlso: Standard careAll 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. | Behavioural | Information and patient education |
| Information, education and physiotherapyAlso: Physiotherapy, Multimodal interventionPatients 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. | Other | Information, education and physiotherapy |
Primary outcome
Change in 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
Perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever".
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: Baseline, 3, 6, 12 and 24months
EQ5D
Time frame: Baseline, 3, 6, 12 and 24months
Neuromuscular function
Time frame: Baseline and 3 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 24 Mar 2016.
- Derived from this study: PubMed 25388552Rathleff 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.
- Derived from this study: PubMed 23508216Rathleff 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.
- Derived from this study: PubMed 22280484Rathleff 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.
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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.
Michael S Rathleff principal investigator
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Ewa M Roos, Ph.d study chair
Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark
Jens L Olesen, MD, Ph.d study chair
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient information and education and Information, education and physiotherapy in people with Patellofemoral Pain Syndrome, run by Mogens Berg Laursen 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 5 inclusion and 6 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 24 Mar 2016. 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?
Change in 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). 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 NCT01438762, which also lists 3 linked publications.
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 24 Mar 2016.