Patellofemoral SyndromePhase 1NCT00166777
Effect of Hip Adduction Combination With Knee Extension Exercise on Morphology of Quadriceps Muscles, Pain and Functional Outcomes in Patients With PFPS
A Phase 1 study testing exercise training in people with Patellofemoral Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Quadriceps retraining, especially the vastus medialis oblique muscle strengthening, plays an important role in clinical management of patellofemoral pain syndrome. Vastus medialis oblique muscle roles as a dynamic stabilizer during the functional knee movement. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Patellofemoral Syndrome
- What is being tested?
- exercise training
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2005to Jun 2006
- Phase
- Phase 1
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with unilateral or bilateral patellofemoral pain syndrome:
- age <50 y/o
- have anterior or retropatellar knee pain on at least 2 of the following activities: prolonged sitting, ascending or descending stairs, squatting, running, kneeling, hopping/jumping
- have anterior or retropatellar knee pain on at least 2 of the following evaluations: patellar palpation, resisted knee extension, patellar compression
- have symptoms for at least 1 month, and pain level >3cm on a VAS scale
Who cannot join
- have severe knee pain (>8cm on a VAS scale) or referred pain
- recent history (within 3 months) of medical therapy for pain relief
- have history of knee surgery
- have central or peripheral neurological pain
- have severe knee deformity or malalignment of lower extremities
- have regular exercise habits (15-20 mins/time, >3times/week)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTU
Taipei
MH Jan, master, 886233228138, mhjan@ntu.edu.tw
About this study
Quadriceps retraining, especially the vastus medialis oblique muscle strengthening, plays an important role in clinical management of patellofemoral pain syndrome. Vastus medialis oblique muscle roles as a dynamic stabilizer during the functional knee movement. It can generate a medial pulling force to patella against the lateral pulled by vastus lateralis. Thus it improves the patellofemoral joint compression force, reduces the knee pain, increases functional abilities, and patients' quality of life.
Could vastus medialis oblique be isolation by way of specific exercise without or minimize the recruitment of vastus lateralis？ According to human anatomy, vastus medialis oblique muscle origin from hip adductor magnus tendon, thus if incorporate hip adduction with knee extension as a selective means of training needs more researches. However, literature search shows that there are only a lot of EMG studies, so we need further clinical research to prove the treatment effect of this kind of strategy.
Read more
The purpose of the study is to investigate the treatment effects of hip adduction combine knee extension exercise in patients with patellofemoral pain syndrome. We use muscle morphology of quadriceps muscle, pain, and functional abilities as the main outcome measures. Besides, we will make further compare with traditional knee extension exercise. The first hypothesis of the study is that patients with patellofemoral pain syndrome will get improvement in muscle morphology of quadriceps muscle, pain, and functional abilities after hip adduction combine knee extension exercise training . The second hypothesis is that patients with patellofemoral pain syndrome who receive hip adduction combine knee extension exercise training will get more improvement in muscle morphology of quadriceps muscle, pain, and functional abilities than patients who receive traditional knee extension exercise training.
90 patients with patellofemoral pain syndrome who less than 50 years old will be included in this study, and randomly distributed to hip adduction combine knee extension exercise group, knee extension exercise group, and control group. Following 8 weeks exercise training by an experimental physical therapist, ultrasound measurement of muscle thickness and cross-sectional area of vastus medialis oblique muscle, vastus lateralis muscle, and rectus femoris muscle component of quadriceps, 10cm-VAS patellofemoral joint pain evaluation, including VAS-U, VAS-W, and VAS-activity, and Lysholm scale scores will be measured. A two-way mixed ANOVA will be used to compare the mean differences between theses three groups.
The study is aimed to provide an clinical evidence for evidence-based practice of rehabilitation in patients with patellofemoral pain syndrome.
- Conditions
- Patellofemoral Syndrome
- Being tested
- exercise training
- 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.
exercise trainingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle morphology of quadriceps
pain serverity
functional ability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 1
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- MH Jan, master, Study chair, National Taiwan Uneversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166777
- Sponsor's protocol ID
- 9461700808
- Status last verified
- Aug 2005
- First submitted
- 11 Sep 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hip Adduction Combination With Knee Extension Exercise on Morphology of Quadriceps Muscles, Pain and Functional Outcomes in Patients With PFPS
- ClinicalTrials.gov ID
- NCT00166777
- Acronym / sponsor ID
- 9461700808
- Conditions
- Patellofemoral Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Jun 2006
- First posted
- 14 Sep 2005 (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.
Quadriceps retraining, especially the vastus medialis oblique muscle strengthening, plays an important role in clinical management of patellofemoral pain syndrome. Vastus medialis oblique muscle roles as a dynamic stabilizer during the functional knee movement. It can generate a medial pulling force to patella against the lateral pulled by vastus lateralis. Thus it improves the patellofemoral joint compression force, reduces the knee pain, increases functional abilities, and patients' quality of life.
Could vastus medialis oblique be isolation by way of specific exercise without or minimize the recruitment of vastus lateralis？ According to human anatomy, vastus medialis oblique muscle origin from hip adductor magnus tendon, thus if incorporate hip adduction with knee extension as a selective means of training needs more researches. However, literature search shows that there are only a lot of EMG studies, so we need further clinical research to prove the treatment effect of this kind of strategy.
The purpose of the study is to investigate the treatment effects of hip adduction combine knee extension exercise in patients with patellofemoral pain syndrome. We use muscle morphology of quadriceps muscle, pain, and functional abilities as the main outcome measures. Besides, we will make further compare with traditional knee extension exercise. The first hypothesis of the study is that patients with patellofemoral pain syndrome will get improvement in muscle morphology of quadriceps muscle, pain, and functional abilities after hip adduction combine knee extension exercise training . The second hypothesis is that patients with patellofemoral pain syndrome who receive hip adduction combine knee extension exercise training will get more improvement in muscle morphology of quadriceps muscle, pain, and functional abilities than patients who receive traditional knee extension exercise training.
90 patients with patellofemoral pain syndrome who less than 50 years old will be included in this study, and randomly distributed to hip adduction combine knee extension exercise group, knee extension exercise group, and control group. Following 8 weeks exercise training by an experimental physical therapist, ultrasound measurement of muscle thickness and cross-sectional area of vastus medialis oblique muscle, vastus lateralis muscle, and rectus femoris muscle component of quadriceps, 10cm-VAS patellofemoral joint pain evaluation, including VAS-U, VAS-W, and VAS-activity, and Lysholm scale scores will be measured. A two-way mixed ANOVA will be used to compare the mean differences between theses three groups.
The study is aimed to provide an clinical evidence for evidence-based practice of rehabilitation in patients with patellofemoral pain syndrome.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients with unilateral or bilateral patellofemoral pain syndrome:
Key exclusion criteria (6 listed)
- have severe knee pain (>8cm on a VAS scale) or referred pain
- recent history (within 3 months) of medical therapy for pain relief
- have history of knee surgery
- have central or peripheral neurological pain
- have severe knee deformity or malalignment of lower extremities
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 |
|---|---|---|
| exercise training | Procedure or surgery | – |
Primary outcome
muscle morphology of quadriceps
pain serverity
functional ability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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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.
MH Jan, master study chair
National Taiwan Uneversity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exercise training in people with Patellofemoral Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 11 Sep 2006. 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 Taiwan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle morphology of quadriceps. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2006; AzTrials last refreshed its copy on 6 Nov 2026.