Patellofemoral Pain SyndromeNCT01290705
Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome.
A study testing High exercise therapy and Low exercise therapy in people with Patellofemoral Pain Syndrome, run by Norwegian University of Science and Technology.
Trial summary
With this study two different therapeutic exercise regimens will be compared in patients with anterior knee pain (patellofemoral pain syndrome, PFPS). Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- High exercise therapy and Low exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Dec 2010
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Knee osteoarthrosis/ arthritis
- previous knee injury or knee operations
- patellar tendinopathy
- Osgood- Schlatter's disease
- Other defined pathological conditions of the knee
About this study
Official title: Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome. A Randomized Controlled Clinical Trial.
With this study two different therapeutic exercise regimens will be compared in patients with anterior knee pain (patellofemoral pain syndrome, PFPS).
Read the detailed description
Exercise therapy is widely used in the conservative treatment of patellofemoral pain syndrome (PFPS), but there is still no consensus on recommending any specific rehabilitation program.
This study evaluates two different therapeutic exercise regimens in patients with PFPS and their effect on pain at rest and function.
Supervised exercise therapy will be applied in both groups three times a week over a 3-month period with individually tailored and graded exercise programs, differing between groups in terms of number of exercises, number of repetitions and sets, and time spent on performing aerobic exercises.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- High exercise therapy, Low exercise therapy
- Keywords
- Knee, Anterior Cruciate Ligament, Pain, Patella, Exercise Therapy
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High exercise therapyBehavioural
Low exercise therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| high exercise | Experimental | High dose, high repetition exercise therapy, 3 times weekly in 12 weeks Receives: Behavioral: High exercise therapy |
| low exercise | Experimental | low dose, low repetition exercise therapy, 3 times weekly in 12 weeks Receives: Behavioral: Low exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured by a Visual analogue scale (VAS).
This scale was illustrated with a 100 mm horizontal line with descriptors "no pain" at the 0 mm mark and "worst pain imaginable" anchoring the 100 mm. Participants were required to place a vertical mark on the horizontal line, representing their average level of pain experienced during the last 24 hours. This was done at rest and provided an illustration of the perceived pain severity, rated in millimetres.
Measured: Pre-test, post-test (after completed intervention at 3 months) and one year follow-up.
Secondary outcomes (1)
Function measured by a Step-down test and by a modified Functional Index Questionnaire (FIQ).
Measured: Pre-test, post-test (at 3 months after completed intervention) and at one year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startNov 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Harry Størksen, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290705
- Sponsor's protocol ID
- 17790
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2011
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Osteras B, Osteras H, Torstensen TA. Long-term effects of medical exercise therapy in patients with patellofemoral pain syndrome: results from a single-blinded randomized controlled trial with 12 months follow-up. Physiotherapy. 2013 Dec;99(4):311-6. doi: 10.1016/j.physio.2013.04.001. Epub 2013 Jun 10.
PubMed 23764516Osteras B, Osteras H, Torstensen TA, Vasseljen O. Dose-response effects of medical exercise therapy in patients with patellofemoral pain syndrome: a randomised controlled clinical trial. Physiotherapy. 2013 Jun;99(2):126-31. doi: 10.1016/j.physio.2012.05.009. Epub 2012 Jul 24.
PubMed 23219636
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01290705
- Acronym / sponsor ID
- 17790
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Knee, Anterior Cruciate Ligament, Pain, Patella, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Feb 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.
With this study two different therapeutic exercise regimens will be compared in patients with anterior knee pain (patellofemoral pain syndrome, PFPS).
Detailed description
Exercise therapy is widely used in the conservative treatment of patellofemoral pain syndrome (PFPS), but there is still no consensus on recommending any specific rehabilitation program.
This study evaluates two different therapeutic exercise regimens in patients with PFPS and their effect on pain at rest and function.
Supervised exercise therapy will be applied in both groups three times a week over a 3-month period with individually tailored and graded exercise programs, differing between groups in terms of number of exercises, number of repetitions and sets, and time spent on performing aerobic exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high exercise | Experimental | Behavioral: High exercise therapyHigh dose, high repetition exercise therapy, 3 times weekly in 12 weeks |
| low exercise | Experimental | Behavioral: Low exercise therapylow dose, low repetition exercise therapy, 3 times weekly in 12 weeks |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Knee osteoarthrosis/ arthritis
- previous knee injury or knee operations
- patellar tendinopathy
- Osgood- Schlatter's disease
- Other defined pathological conditions of the knee
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 |
|---|---|---|
| High exercise therapy | Behavioural | high exercise |
| Low exercise therapy | Behavioural | low exercise |
Primary outcome
Pain measured by a Visual analogue scale (VAS).
Time frame: Pre-test, post-test (after completed intervention at 3 months) and one year follow-up.
This scale was illustrated with a 100 mm horizontal line with descriptors "no pain" at the 0 mm mark and "worst pain imaginable" anchoring the 100 mm. Participants were required to place a vertical mark on the horizontal line, representing their average level of pain experienced during the last 24 hours. This was done at rest and provided an illustration of the perceived pain severity, rated in millimetres.
1 secondary outcome
Function measured by a Step-down test and by a modified Functional Index Questionnaire (FIQ).
Time frame: Pre-test, post-test (at 3 months after completed intervention) and at one year follow-up.
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 18 Feb 2016.
- Results publication: PubMed 23764516Osteras B, Osteras H, Torstensen TA. Long-term effects of medical exercise therapy in patients with patellofemoral pain syndrome: results from a single-blinded randomized controlled trial with 12 months follow-up. Physiotherapy. 2013 Dec;99(4):311-6. doi: 10.1016/j.physio.2013.04.001. Epub 2013 Jun 10.
- Results publication: PubMed 23219636Osteras B, Osteras H, Torstensen TA, Vasseljen O. Dose-response effects of medical exercise therapy in patients with patellofemoral pain syndrome: a randomised controlled clinical trial. Physiotherapy. 2013 Jun;99(2):126-31. doi: 10.1016/j.physio.2012.05.009. Epub 2012 Jul 24.
- Individual participant dataSharing planned: Undecided
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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.
Jan Harry Størksen study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing High exercise therapy and Low exercise therapy in people with Patellofemoral Pain Syndrome, run by Norwegian University of Science and Technology.
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 0 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain measured by a Visual analogue scale (VAS). (time frame: Pre-test, post-test (after completed intervention at 3 months) and one year follow-up.). 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 NCT01290705, which also lists 2 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 18 Feb 2016.