Patellofemoral Pain SyndromeNCT01504100
Efficiency of Patellar Taping in Treatment of Patellofemoral Pain Syndrome
An observational study of Patellofemoral Pain Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been reported good outcomes in most patients. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2011to Oct 2013
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: 100 patients
Who may be able to join
- anterior knee pain
- radiographic evidence of patellar subluxation
Who cannot join
- history of patellar dislocation
- osteoarthritis of ipsilateral knee
- pregnancy
- history of knee injury
- BMI > 35
- allergy to taping
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Orthopaedic Surgery, National Taiwan University Hospital
Taipei, 886
About this study
Official title: The Effects of Distal Femoral Rotation on Patellofemoral Pain Syndrome Treated With Patella Taping
Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been reported good outcomes in most patients. However, some studies reported less effective in patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q angle. The investigators hypothesized that femoral internal rotation is a negative factor to the patellar taping. The investigators enroll consecutive 100 patients with anterior knee pain and radiographic evidence of patellar subluxation. The investigators determine femoral rotation via physical examination. The visual analogue scale was evaluate to compare the result between the those with and without femoral internal rotation.
Read the detailed description
Consecutive 100 patients with anterior knee pain and compatible with inclusion criteria. Before treatment, an independent physiotherapist evaluates whether femoral internal rotation or not via physical therapy, and another studying nurse records the visual analog scale and measures Q angle. After evaluation, McConnell taping is applied to these patients. Two weeks later, outcomes are recorded including visual analog scale, satisfactory, and complication. The outcomes are compared between those with and without femoral internal rotation.
- Conditions
- Patellofemoral Pain Syndrome
- 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.
| Study group | Role | What they receive |
|---|---|---|
| femoral internal rotation | Not described | |
| no femoral internal rotation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
The visual analog scale are measured before and two weeks after taping.
Measured: two weeks
Secondary outcomes (1)
Satisfactory
The patients recorded the satisfactory score by theyself from 0 to 10. Ten degree means most satisfactory.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionOct 2013
- Study completionOct 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Chuan Jiang, MD. PhD, Study chair, Department of Orthopaedic Surgery, National Taiwan University Hospital, 7 Chungsan South Road, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504100
- Sponsor's protocol ID
- 201103111RC
- Status last verified
- Oct 2013
- First submitted
- 1 Jul 2011
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Distal Femoral Rotation on Patellofemoral Pain Syndrome Treated With Patella Taping
- ClinicalTrials.gov ID
- NCT01504100
- Acronym / sponsor ID
- 201103111RC
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Jan 2012 (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.
Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been reported good outcomes in most patients. However, some studies reported less effective in patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q angle. The investigators hypothesized that femoral internal rotation is a negative factor to the patellar taping. The investigators enroll consecutive 100 patients with anterior knee pain and radiographic evidence of patellar subluxation. The investigators determine femoral rotation via physical examination. The visual analogue scale was evaluate to compare the result between the those with and without femoral internal rotation.
Detailed description
Consecutive 100 patients with anterior knee pain and compatible with inclusion criteria. Before treatment, an independent physiotherapist evaluates whether femoral internal rotation or not via physical therapy, and another studying nurse records the visual analog scale and measures Q angle. After evaluation, McConnell taping is applied to these patients. Two weeks later, outcomes are recorded including visual analog scale, satisfactory, and complication. The outcomes are compared between those with and without femoral internal rotation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femoral internal rotation | – | – |
| no femoral internal rotation | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 patients
Key inclusion criteria (2 listed)
- anterior knee pain
- radiographic evidence of patellar subluxation
Key exclusion criteria (6 listed)
- history of patellar dislocation
- osteoarthritis of ipsilateral knee
- pregnancy
- history of knee injury
- BMI > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knee pain
Time frame: two weeks
The visual analog scale are measured before and two weeks after taping.
1 secondary outcome
Satisfactory
Time frame: 2 weeks
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 31 Oct 2013.
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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.
Ching-Chuan Jiang, MD. PhD study chair
Department of Orthopaedic Surgery, National Taiwan University Hospital, 7 Chungsan South Road, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 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 31 Oct 2013. 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?
Knee pain (time frame: two weeks). 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 31 Oct 2013.