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NCT02461095 · ClinicalTrials.gov registry record · NA
Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome
A NA study of Patellofemoral Pain Syndrome, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 4
- Study locations
NCT02461095: Completed NA study of Patellofemoral Pain Syndrome, sponsored by Nationwide Children's Hospital.
NCT02461095 is a NA study of Patellofemoral Pain Syndrome that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 55 participants, below the 141-participant average among 10 other Patellofemoral Pain Syndrome trials with a reported enrollment target (61% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02461095, a NA study of Patellofemoral Pain Syndrome, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 4
- Study locations
Study Summary
Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been identified as an important factor in patients with PFPS. The authors hypothesize that an ordered approach addressing each of these impairments sequentially will result in greater improvement in PFPS symptoms. The results of the investigators pilot study assessing the feasibility of using a sequential approach showed a full randomized controlled trial is warranted, the authors now plan to proceed with a full trial. The objective of this study is to assess the efficacy of a sequential approach in the treatment of Patellofemoral Pain Syndrome. Methods: Patients will be randomized to a sequential treatment approach using a PFPS treatment algorithm (PFPS Algorithm) designed by the authors or typical physical therapy care. Due to the constant evaluation necessary no blinding will be performed. Patients will attend therapy two times per week for six weeks. Pain, Anterior Knee Pain Scale (AKPS), and Global Rating of Change (GROC) will be measured at evaluation and discharge, 3 month follow-up and 6 month follow-up.
Primary Outcome
Assessment of change of the Anterior Knee Pain Scale (AKPS). The AKPS is a self-reported 13 item questionnaire with discrete categories related to various levels of current knee function. Categories within each item are weighted, and responses are summed to provide an overall score of 0-100, with 100 representing no disability. The Anterior Knee Pain Scale is found to be valid and reliable in patients from 12-50 years of age presenting with anterior knee pain with a test-retest reliability of .9
Conditions Studied
Interventions
- OTHER Impairment based approach
- OTHER PFPS Algorithm approach
Study Locations (4)
Ohio
- Nationwide Children's Hospital Sports and Ortho PT East Broad - Columbus
- Nationwide Children's Hospital Sports and Ortho PT Dublin - Dublin
- Nationwide Children's Hospital Sports and Ortho PT New Albany - New Albany
- Nationwide Children's Hospital Sports and Orthopedic PT Westerville location - Westerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-10 |
| Phase | NA |
What the finished NCT02461095 record still lists
NCT02461095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 141-participant average among 10 other Patellofemoral Pain Syndrome trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Patellofemoral Pain Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Impairment based approach is the first listed.
NCT02461095 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02461095 about?
NCT02461095 is a clinical study titled "Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome". Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been identified as an important factor in patients with PFPS. The authors hypothesize that an ordered approach addressing each...
What is the current status of trial NCT02461095?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2015-06. Estimated completion is 2017-10.
What conditions does trial NCT02461095 study?
This clinical trial studies the following conditions: Patellofemoral Pain Syndrome.
What interventions are being tested in trial NCT02461095?
The interventions under investigation include: Impairment based approach (OTHER), PFPS Algorithm approach (OTHER).
Who is sponsoring clinical trial NCT02461095?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02461095 being conducted?
This trial has 4 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02461095's enrollment target sits among peer trials
55 6th of 10 higher than 5 of 10 other Patellofemoral Pain Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Patellofemoral Pain Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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