Patellofemoral Pain SyndromeNCT00736736
Effects of Hip Abductor and External Rotator Strength Training in Patients With Patellofemoral Pain Syndrome
A study testing Additional Hip Muscle Strengthening to Leg Press Exercise and Leg Press Exercise in people with Patellofemoral Pain Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The first purpose was to compare the difference between leg press exercise(LPE) and additional hip abductor and external rotator muscle strength training to leg press exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and function for patients diagnosed with patellofemoral pain… Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Additional Hip Muscle Strengthening to Leg Press Exercise and Leg Press Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2008to Jul 2008
- 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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patellofemoral pain syndrome ( Bilateral or unilateral)
- Special tests: crepitus during compression test, patellar grind test (Clarke's sign), pain during compression test, palpation ( at least 2 )
- Below 50 years old
- Pain :after long sitting, up/down stair, squat, kneeling, running \& jumping ( at least 2 )
- Pain duration at least 1 month
- At least 1 item of PSS score more than 3 cm
Who cannot join
- Knee operation
- Central or peripheral neurological deficits
- Obvious knee joint or lower extremity malalignment
- People involved in competitive sports
- PSS sub-scale pain experienced last week more than 8cm
- Have been taking anti-inflammatory drugs , received anti-inflammatory injection or received other therapy for past 3 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
The School and Graduate Institute of Physical Therapy of National Taiwan University
Taipei, 100
About this study
The first purpose was to compare the difference between leg press exercise(LPE) and additional hip abductor and external rotator muscle strength training to leg press exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and function for patients diagnosed with patellofemoral pain syndrome. The second one was to discover the relationship between the change in muscle strength performance and the difference of hip joint kinematics post treatment.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Additional Hip Muscle Strengthening to Leg Press Exercise, Leg Press Exercise
- 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.
Additional Hip Muscle Strengthening to Leg Press ExerciseOther
Leg Press ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Leg Press | Active comparator | Leg Press exercise for 3 times/week and sustain for 8 weeks. Receives: Other: Leg Press Exercise |
| Hip Exercise | Experimental | Additional hip abductor and hip external rotator strength training to leg press exercise for people in this group. All participants received exercise for 3 times per week for 8 weeks. Receives: Other: Additional Hip Muscle Strengthening to Leg Press Exercise |
| Control | No intervention | Education was given during 8 weeks of study period. After 8 weeks of study, exercise was given as compensation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength by hand-held dynamometry, hip joint kinematics during step down by electromagnetic motion tracking system (FASTRAK, Polhemus ), pain severity by PFPS pain severity scale (PSS), functional performance by Anterior Knee Pain Scale(AKP).
Measured: Pre and Post 8 weeks of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2008
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Hwa Jan, Study chair, The School and Graduate Institute of Physical Therapy of National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736736
- Sponsor's protocol ID
- 200801069R
- Status last verified
- Jun 2008
- First submitted
- 14 Aug 2008
- Last updated
- 18 Aug 2008
- Results posted
- No
Publications
Mascal CL, Landel R, Powers C. Management of patellofemoral pain targeting hip, pelvis, and trunk muscle function: 2 case reports. J Orthop Sports Phys Ther. 2003 Nov;33(11):647-60. doi: 10.2519/jospt.2003.33.11.647.
PubMed 14669960
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hip Abductor and External Rotator Strength Training in Patients With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT00736736
- Acronym / sponsor ID
- 200801069R
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2008 (actual)
- First posted
- 18 Aug 2008 (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.
The first purpose was to compare the difference between leg press exercise(LPE) and additional hip abductor and external rotator muscle strength training to leg press exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and function for patients diagnosed with patellofemoral pain syndrome. The second one was to discover the relationship between the change in muscle strength performance and the difference of hip joint kinematics post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leg Press | Active comparator | Other: Leg Press ExerciseLeg Press exercise for 3 times/week and sustain for 8 weeks. |
| Hip Exercise | Experimental | Other: Additional Hip Muscle Strengthening to Leg Press ExerciseAdditional hip abductor and hip external rotator strength training to leg press exercise for people in this group. All participants received exercise for 3 times per week for 8 weeks. |
| Control | No intervention | –Education was given during 8 weeks of study period. After 8 weeks of study, exercise was given as compensation. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patellofemoral pain syndrome ( Bilateral or unilateral)
- Special tests: crepitus during compression test, patellar grind test (Clarke's sign), pain during compression test, palpation ( at least 2 )
- Below 50 years old
- Pain :after long sitting, up/down stair, squat, kneeling, running \& jumping ( at least 2 )
- Pain duration at least 1 month
Key exclusion criteria (6 listed)
- Knee operation
- Central or peripheral neurological deficits
- Obvious knee joint or lower extremity malalignment
- People involved in competitive sports
- PSS sub-scale pain experienced last week more than 8cm
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 |
|---|---|---|
| Additional Hip Muscle Strengthening to Leg Press Exercise | Other | Hip Exercise |
| Leg Press Exercise | Other | Leg Press |
Primary outcome
Muscle Strength by hand-held dynamometry, hip joint kinematics during step down by electromagnetic motion tracking system (FASTRAK, Polhemus ), pain severity by PFPS pain severity scale (PSS), functional performance by Anterior Knee Pain Scale(AKP).
Time frame: Pre and Post 8 weeks of exercise
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 Aug 2008.
- Background: PubMed 14669960Mascal CL, Landel R, Powers C. Management of patellofemoral pain targeting hip, pelvis, and trunk muscle function: 2 case reports. J Orthop Sports Phys Ther. 2003 Nov;33(11):647-60. doi: 10.2519/jospt.2003.33.11.647.
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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.
Mei-Hwa Jan study chair
The School and Graduate Institute of Physical Therapy of National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional Hip Muscle Strengthening to Leg Press Exercise and Leg Press Exercise in people with Patellofemoral Pain 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 6 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 18 Aug 2008. 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.
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?
Muscle Strength by hand-held dynamometry, hip joint kinematics during step down by electromagnetic motion tracking system (FASTRAK, Polhemus ), pain severity by PFPS pain severity scale (PSS), functional performance by Anterior Knee Pain Scale(AKP). (time frame: Pre and Post 8 weeks of exercise). 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 NCT00736736, 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 18 Aug 2008.