Patellofemoral Pain SyndromeCOMPETENCT03069547
Comparison of Exercise Therapies for Patellofemoral Pain
A study testing Quadriceps Exercise program and Hip Exercise program in people with Patellofemoral Pain Syndrome, run by Marius Henriksen at 1 site in Denmark.
Trial summary
Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young adults. PFP is characterised by significant retropatellar and/or peripatellar pain and impairment of function and quality of daily life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Quadriceps Exercise program and Hip Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Apr 2017to 3 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of PFP in at least one knee
- Visual analogue score rating of pain during activities of daily living during the previous week at a minimum of 3 on a 10 cm scale.
- Insidious onset of symptoms unrelated to trauma and persistent for at least 4 weeks.
- Pain in the anterior knee associated with at least 3 of the following:
- During or after activity
- Prolonged sitting
- Stair ascent or descent
- Squatting
Who cannot join
- Meniscal or other intra-articular injury
- Cruciate or collateral ligament laxity or tenderness
- Patellar tendon, iliotibial band, or pes anserine tenderness
- Osgood-Schlatter or Sinding-Larsen-Johansson syndrome
- History of recurrent patellar subluxation or dislocation
- History of surgery to the knee joint
- History of head injury or vestibular disorder within the last 6 months
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, 2400
About this study
Official title: Comparative Effectiveness of Therapeutic Hip and Knee Exercise for Atellofemoral Pain: A Pragmatic Randomised Trial
Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young adults. PFP is characterised by significant retropatellar and/or peripatellar pain and impairment of function and quality of daily life. Exercise therapy is unequivocally recommended as a core component of the management of PFP. Different exercise types (e.g. quadriceps strengthening, hip strengthening and functional/neuromuscular exercises) have been investigated, with knee and hip strengthening exercises as the most common and recommended types. These exercises approaches produce similar small to moderate effects on pain and physical function. However, the PFP population is very heterogeneous and "one-size-fits-all"-approaches presumably are sub-optimal because the heterogeneity is ignored. The heterogeneity probably explains the overall limited beneficial effects of exercise, and the lack of differences in direct comparisons of different exercise types. In that sense, it is not unlikely that certain patient characteristics may predict outcome success of either a hip training program or a training program that focus on the quadriceps but this remains to be shown.
This study has two aims:
Read more
- To assess the comparative effectiveness of two different exercise programs (Quadricep Exercise [QE] vs. Hip Exercise [HE]) on self-reported pain and function in individuals with PFP.
- To explore candidate patient characteristics that predict differential responses to the two exercise programs (QE vs HE) on self-reported pain and physical function in individuals with PFP.
According to the study aims we pursue the following hypothesis:
- QE and HE have equivalent efficacy on self-reported pain after 12 weeks of treatment in patients with PFP.
The second study aim is to explore possible candidate patient characteristics that may associate with differential outcomes. As this is exploratory, the pursuit of this aim is hypothesis-free.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Quadriceps Exercise program, Hip Exercise program
- 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.
Quadriceps Exercise programOther
The exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits.
The program details can be requested rom the responsible party. In brief the QE-program consists of:
- A short warm-up and 3 specific exercises for the quadriceps muscle
Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, free weights, etc.
Hip Exercise programOther
The exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits.
The program details be requested rom the responsible party. In brief the HE-program consists of:
- A short warm-up and 3 specific exercises for the hip abductor and extensor muscles
Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, body weight etc.
| Study group | Role | What they receive |
|---|---|---|
| Quadriceps Exercise program | Active comparator | The Quadricepts Exercise (QE) program runs for 12 weeks, with exercise sessions 3 times per week. Each training session is scheduled to last approximately 30 minutes. The exercise program is home based with monthly supervision visits at the clinic. Receives: Other: Quadriceps Exercise program |
| Hip Exercise program | Active comparator | The Hip Exercise (HE) program runs for 12 weeks, with exercise sessions 3 times per week. Each training session is scheduled to last approximately 30 minutes. The exercise program is home based with monthly supervision visits at the clinic. Receives: Other: Hip Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the KUJALA scoring questionnaire
The Kujala Patellofemoral Scale - sometimes called the anterior knee pain scale - is disease specific validated disability scale ranging from 0 (complete disability) to 100 (fully functional). It is a 13-item self-report questionnaire that documents response to 6 activities (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear, swelling, abnormal patellar movement, muscle atrophy, and limitations in knee flexion.
Measured: week 12 and 26
Secondary outcomes (6)
Change from baseline in the KOOS questionnaire
The Knee injury and Osteoarthritis Outcome Score (KOOS) is used to assess patient-reported knee-related symptoms. The KOOS is a patient-reported outcome measurement instrument developed to assess the patient's opinion about their knee and associated problems.KOOS comprises of 42 items in 5 separately scored subdomains: KOOS Pain (9 items), KOOS Symptoms (7 items), Function in daily living (KOOS Function; 17 items), Function in Sport and Recreation (5 items), and Knee-related Quality of Life (4 items). The previous week is the time period considered when answering the questions, and the questions relate to one knee (the target knee in this trial).
Measured: Week 12 and 26
Change fom baseline in isometric muscle strength of hip abductors, hip external rotators, hip extensors, and quadriceps
Isometric muscle strength of hip abductors, hip external rotators, quadriceps, and hamstrings is performed by using a handheld dynamometer following a previously published testing protocol.
Measured: Week 12
Change fom baseline in the Dynamic Assessment of Pain test
The Dynamic Assessment of Pain Test is a simple performance test with an integrated pain score, designed to provide useful information for monitoring treatment progress and evaluating treatment effects in clinical physiotherapy practice. The patient is asked to perform as many squatting movements (both legs) as possible within 30 seconds. The knees should reach approximately 90 degrees of flexion and full extension for each squat. This is supervised by the rater. There outcome of the test is the knee pain during the test on a 0-10 Numeric Rating Scale (NRS) rated immediately after the test.
Measured: Week 12
Change fom baseline in the Pain Self-Efficacy Questionnaire
The pain self-efficacy questionnaire is a 10-item questionnaire developed to assess the confidence people with pain have in performing activities while in pain. It is applicable to all persisting pain presentations, and covers a range of functions. Confidence in performing activities are rated on a 7-point (0-6) Likert scale with 0 representing not at all confident and 6 representing completely confident. A total score is calculated by summing the answers producing a score between 0 and 60. Higher scores reflect stronger self-efficacy beliefs.
Measured: Week 12 and 26
Change fom baseline in the EuroQoL Questionnaire
The EuroQoL questionnaire is a standardised patient-reported instrument for use as a measure of health related quality of life.
Measured: Week 12 and 26
Transition Questionnaire of global perceived effect on overall health, pain, and function
The Transition Questionnaire of global perceived effect is an adaptive questionnaire in which the participants initially answer if their current state is "unchanged, worse" or "better" compared to the baseline visit. An "unchanged" equals a transition score of 0. If the participant answers "worse", he/she is asked to rate the degree of worsening on a 7 point Likert scale, and the corresponding scores range from -1 to -7. Correspondingly, if a participant answers "better", he/she is asked to rate the degree of improvement on a 7 point Likert scale, and the corresponding scores range from 1 to 7. Thus the Transition score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change. The transition scale is used to assess overall knee related health status.
Measured: Week 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start10 Apr 2017
- Primary completion3 Dec 2021
- Study completion3 Mar 2022
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
- Model description
- Eligible participants will be randomly assigned (1:1) to one of the two following groups: * QE - quadriceps exercise program * HE - hip exercise program
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Marius Henriksen, PT, PhD, Study chair, Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069547
- Sponsor's protocol ID
- FYS-2016-004
- Acronym
- COMPETE
- Status last verified
- Aug 2022
- First submitted
- 22 Feb 2017
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared once the study is finalised and results pulished. IPD can be obtained by contacting the responsible party
Publications
Hansen R, Rathleff MS, Brushoj C, Magnusson SP, Henriksen M. Differential Effects of Quadriceps and Hip Muscle Exercises for Patellofemoral Pain: A Secondary Effect Modifier Analysis of a Randomized Trial. J Orthop Sports Phys Ther. 2024 Nov;54(11):732-742. doi: 10.2519/jospt.2024.12503.
PubMed 39478429Jorgensen JEV, Rathleff MS, Henriksen M, Brushoj C, Hansen R. Physical Therapists' Prognosis of Outcomes After a Hip or Quadriceps Exercise Intervention in Patients With Patellofemoral Pain: A Secondary Analysis of a Randomized Trial. J Orthop Sports Phys Ther. 2024 Aug;54(8):541-550. doi: 10.2519/jospt.2024.12258.
PubMed 38840581Hansen R, Brushoj C, Rathleff MS, Magnusson SP, Henriksen M. Quadriceps or hip exercises for patellofemoral pain? A randomised controlled equivalence trial. Br J Sports Med. 2023 Oct;57(20):1287-1294. doi: 10.1136/bjsports-2022-106197. Epub 2023 May 3.
PubMed 37137673
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Therapeutic Hip and Knee Exercise for Atellofemoral Pain: A Pragmatic Randomised Trial
- ClinicalTrials.gov ID
- NCT03069547
- Acronym / sponsor ID
- COMPETE / FYS-2016-004
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 3 Mar 2017 (actual)
- 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.
Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young adults. PFP is characterised by significant retropatellar and/or peripatellar pain and impairment of function and quality of daily life. Exercise therapy is unequivocally recommended as a core component of the management of PFP. Different exercise types (e.g. quadriceps strengthening, hip strengthening and functional/neuromuscular exercises) have been investigated, with knee and hip strengthening exercises as the most common and recommended types. These exercises approaches produce similar small to moderate effects on pain and physical function. However, the PFP population is very heterogeneous and "one-size-fits-all"-approaches presumably are sub-optimal because the heterogeneity is ignored. The heterogeneity probably explains the overall limited beneficial effects of exercise, and the lack of differences in direct comparisons of different exercise types. In that sense, it is not unlikely that certain patient characteristics may predict outcome success of either a hip training program or a training program that focus on the quadriceps but this remains to be shown.
This study has two aims:
- To assess the comparative effectiveness of two different exercise programs (Quadricep Exercise [QE] vs. Hip Exercise [HE]) on self-reported pain and function in individuals with PFP.
- To explore candidate patient characteristics that predict differential responses to the two exercise programs (QE vs HE) on self-reported pain and physical function in individuals with PFP.
According to the study aims we pursue the following hypothesis:
- QE and HE have equivalent efficacy on self-reported pain after 12 weeks of treatment in patients with PFP.
The second study aim is to explore possible candidate patient characteristics that may associate with differential outcomes. As this is exploratory, the pursuit of this aim is hypothesis-free.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly assigned (1:1) to one of the two following groups: * QE - quadriceps exercise program * HE - hip exercise program
| Arm | Type | Receives |
|---|---|---|
| Quadriceps Exercise program | Active comparator | Other: Quadriceps Exercise programThe Quadricepts Exercise (QE) program runs for 12 weeks, with exercise sessions 3 times per week. Each training session is scheduled to last approximately 30 minutes. The exercise program is home based with monthly supervision visits at the clinic. |
| Hip Exercise program | Active comparator | Other: Hip Exercise programThe Hip Exercise (HE) program runs for 12 weeks, with exercise sessions 3 times per week. Each training session is scheduled to last approximately 30 minutes. The exercise program is home based with monthly supervision visits at the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A clinical diagnosis of PFP in at least one knee
- Visual analogue score rating of pain during activities of daily living during the previous week at a minimum of 3 on a 10 cm scale.
- Insidious onset of symptoms unrelated to trauma and persistent for at least 4 weeks.
- Pain in the anterior knee associated with at least 3 of the following:
Key exclusion criteria (7 listed)
- Meniscal or other intra-articular injury
- Cruciate or collateral ligament laxity or tenderness
- Patellar tendon, iliotibial band, or pes anserine tenderness
- Osgood-Schlatter or Sinding-Larsen-Johansson syndrome
- History of recurrent patellar subluxation or dislocation
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 |
|---|---|---|
| Quadriceps Exercise programThe exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits. The program details can be requested rom the responsible party. In brief the QE-program consists of: - A short warm-up and 3 specific exercises for the quadriceps muscle Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, free weights, etc. | Other | Quadriceps Exercise program |
| Hip Exercise programThe exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits. The program details be requested rom the responsible party. In brief the HE-program consists of: - A short warm-up and 3 specific exercises for the hip abductor and extensor muscles Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, body weight etc. | Other | Hip Exercise program |
Primary outcome
Change from baseline in the KUJALA scoring questionnaire
Time frame: week 12 and 26
The Kujala Patellofemoral Scale - sometimes called the anterior knee pain scale - is disease specific validated disability scale ranging from 0 (complete disability) to 100 (fully functional). It is a 13-item self-report questionnaire that documents response to 6 activities (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear, swelling, abnormal patellar movement, muscle atrophy, and limitations in knee flexion.
6 secondary outcomes
Change from baseline in the KOOS questionnaire
Time frame: Week 12 and 26
Change fom baseline in isometric muscle strength of hip abductors, hip external rotators, hip extensors, and quadriceps
Time frame: Week 12
Change fom baseline in the Dynamic Assessment of Pain test
Time frame: Week 12
Change fom baseline in the Pain Self-Efficacy Questionnaire
Time frame: Week 12 and 26
Change fom baseline in the EuroQoL Questionnaire
Time frame: Week 12 and 26
Transition Questionnaire of global perceived effect on overall health, pain, and function
Time frame: Week 12 and 26
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 2 Aug 2022.
- Derived from this study: PubMed 39478429Hansen R, Rathleff MS, Brushoj C, Magnusson SP, Henriksen M. Differential Effects of Quadriceps and Hip Muscle Exercises for Patellofemoral Pain: A Secondary Effect Modifier Analysis of a Randomized Trial. J Orthop Sports Phys Ther. 2024 Nov;54(11):732-742. doi: 10.2519/jospt.2024.12503.
- Derived from this study: PubMed 38840581Jorgensen JEV, Rathleff MS, Henriksen M, Brushoj C, Hansen R. Physical Therapists' Prognosis of Outcomes After a Hip or Quadriceps Exercise Intervention in Patients With Patellofemoral Pain: A Secondary Analysis of a Randomized Trial. J Orthop Sports Phys Ther. 2024 Aug;54(8):541-550. doi: 10.2519/jospt.2024.12258.
- Derived from this study: PubMed 37137673Hansen R, Brushoj C, Rathleff MS, Magnusson SP, Henriksen M. Quadriceps or hip exercises for patellofemoral pain? A randomised controlled equivalence trial. Br J Sports Med. 2023 Oct;57(20):1287-1294. doi: 10.1136/bjsports-2022-106197. Epub 2023 May 3.
- Individual participant dataSharing planned: Yes. All IPD will be shared once the study is finalised and results pulished. IPD can be obtained by contacting the responsible party
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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.
Marius Henriksen, PT, PhD study chair
Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg 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 Quadriceps Exercise program and Hip Exercise program in people with Patellofemoral Pain Syndrome, run by Marius Henriksen 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 8 inclusion and 7 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 2 Aug 2022. 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 from baseline in the KUJALA scoring questionnaire (time frame: week 12 and 26). 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 NCT03069547, 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 2 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.