Patellofemoral Pain SyndromePhase 1/2NCT00451347
Comparison of The Clinical Effects Between Different Physical Therapy Tools in Patellofemoral Pain Patients
A Phase 1/2 study testing Quadriceps strength training, Taping and Home exercise in people with Patellofemoral Pain Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Objectives:The purpose of this study was to investigate the different effects among the quadriceps strength training, taping, and stretching exercise of iliotibial band in patients with patellofemoral pain syndrome by randomized control trial study. 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?
- Quadriceps strength training, Taping and Home exercise
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2006to Aug 2008
- Phase
- Phase 1/2
- 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
- Anterior or retropatellar knee pain present during at least two of the following: ascending/descending stairs, hopping, running, squatting, kneeling, and prolong sitting
- Insidious onset of symptom unrelated to a traumatic incident
- Pain on palpation of peripatella
- VAS>3
- Age <50 years old
- Symptoms sustained for more than 1 month
Who cannot join
- Over activity: athlete, infatry
- Patients with meniscal lesion, ligamentous instability, patellar tendon pathology, radiation pain from spine, referred pain
- Neurological disease involved
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei, 100
Mei-Hwa Jan, 886-2-33228138, mhjan@ntu.edu.tw
About this study
Objectives:The purpose of this study was to investigate the different effects among the quadriceps strength training, taping, and stretching exercise of iliotibial band in patients with patellofemoral pain syndrome by randomized control trial study.
Method:An observer blind, prospective, factorial design randomized controlled trail. 90 young adults with patellofemoral pain syndrome were randomly allocated into one of three treatment groups: (1) Quadriceps strength training, (2) taping, and (3) stretch. Each group received treatment for 8 weeks.
Hypothesis:Patients in quadriceps strength training group may get most outcomes in three groups
Read the detailed description
Introduction:Patellofemoral pain syndrome ( PFPS ) is a common knee disorder. Factors that cause patellofemoral pain include: over use, soft tissue imbalance, and malalignment of lower extremity. Patients with patellofemoral pain, caused by soft tissue imbalance was thought to be favorite to receive physical therapies. Clinically, physical therapies for patients with PFPS are including: Quadriceps strength training, taping, and stretching exercise. The aforementioned treatment tools showed different effect mechanism. However, there were few clinical studies to compare the clinical effects among the aforementioned three treatment tools. The purpose of this study was to investigate the different effects among the quadriceps strength training, taping, and stretching exercise of iliotibial band in patients with patellofemoral pain syndrome by randomized control trial study.
Methods:An observer blind, prospective, factorial design randomized controlled trail. 90 young adults with patellofemoral pain syndrome were randomly allocated into one of three treatment groups: (1) Quadriceps strength training, (2) taping, and (3) stretch. Each group received treatment for 8 weeks.
Outcome measures were including visual analog scales for worst pain, active-active joint reposition error test, the Chinese version of the Western Ontario and McMaster Universities Osteoarthritis Index, and one repetition maximum recorded at baseline and after the interventions for 8 weeks.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Quadriceps strength training, Taping, Home 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.
Quadriceps strength trainingDevice
TapingDevice
Home exerciseDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS worst
muscle strength
proprioception
functional performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startNov 2006
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Hwa Jan, Study director, Kinesiology Lab, School and Graduate Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451347
- Sponsor's protocol ID
- 200611006R
- Status last verified
- Nov 2006
- First submitted
- 21 Mar 2007
- Last updated
- 23 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Clinical Effects Between Different Physical Therapy Tools in Patellofemoral Pain Patients
- ClinicalTrials.gov ID
- NCT00451347
- Acronym / sponsor ID
- 200611006R
- Conditions
- Patellofemoral Pain Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Aug 2008 (estimated)
- First posted
- 23 Mar 2007 (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.
Objectives:The purpose of this study was to investigate the different effects among the quadriceps strength training, taping, and stretching exercise of iliotibial band in patients with patellofemoral pain syndrome by randomized control trial study.
Method:An observer blind, prospective, factorial design randomized controlled trail. 90 young adults with patellofemoral pain syndrome were randomly allocated into one of three treatment groups: (1) Quadriceps strength training, (2) taping, and (3) stretch. Each group received treatment for 8 weeks.
Hypothesis:Patients in quadriceps strength training group may get most outcomes in three groups
Detailed description
Introduction:Patellofemoral pain syndrome ( PFPS ) is a common knee disorder. Factors that cause patellofemoral pain include: over use, soft tissue imbalance, and malalignment of lower extremity. Patients with patellofemoral pain, caused by soft tissue imbalance was thought to be favorite to receive physical therapies. Clinically, physical therapies for patients with PFPS are including: Quadriceps strength training, taping, and stretching exercise. The aforementioned treatment tools showed different effect mechanism. However, there were few clinical studies to compare the clinical effects among the aforementioned three treatment tools. The purpose of this study was to investigate the different effects among the quadriceps strength training, taping, and stretching exercise of iliotibial band in patients with patellofemoral pain syndrome by randomized control trial study.
Methods:An observer blind, prospective, factorial design randomized controlled trail. 90 young adults with patellofemoral pain syndrome were randomly allocated into one of three treatment groups: (1) Quadriceps strength training, (2) taping, and (3) stretch. Each group received treatment for 8 weeks.
Outcome measures were including visual analog scales for worst pain, active-active joint reposition error test, the Chinese version of the Western Ontario and McMaster Universities Osteoarthritis Index, and one repetition maximum recorded at baseline and after the interventions for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Anterior or retropatellar knee pain present during at least two of the following: ascending/descending stairs, hopping, running, squatting, kneeling, and prolong sitting
- Insidious onset of symptom unrelated to a traumatic incident
- Pain on palpation of peripatella
- VAS>3
- Age <50 years old
Key exclusion criteria (3 listed)
- Over activity: athlete, infatry
- Patients with meniscal lesion, ligamentous instability, patellar tendon pathology, radiation pain from spine, referred pain
- Neurological disease involved
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 strength training | Device | – |
| Taping | Device | – |
| Home exercise | Device | – |
Primary outcome
VAS worst
muscle strength
proprioception
functional performance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2007.
Related trials for Patellofemoral Pain Syndrome
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Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
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MRI Study of Musculoskeletal Function
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
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Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
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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 director
Kinesiology Lab, School and Graduate Institute of Physical Therapy, 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 Phase 1/2 study testing Quadriceps strength training, Taping and Home 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 3 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 23 Mar 2007. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Mei-Hwa Jan, Master (886-2-33228138, mhjan@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS worst. The study lists 4 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 23 Mar 2007.