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NCT04086615 · ClinicalTrials.gov registry record · NA
Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty
A NA study of Patellofemoral Pain Syndrome, sponsored by University of Tennessee.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT04086615: Completed NA study of Patellofemoral Pain Syndrome, sponsored by University of Tennessee.
NCT04086615 is a NA study of Patellofemoral Pain Syndrome that has completed, run by University of Tennessee. The registered enrollment target is 84 participants, below the 138-participant average among 10 other Patellofemoral Pain Syndrome trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04086615, a NA study of Patellofemoral Pain Syndrome, has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall objective of this project is to compare two self-managed treatment regimens for PFPS: (1) NMES-Exercise supplemented with high BFR LOP of 80% and (2) NMES Exercise augmented with a low percentage of BFR LOP at 20 mmHG (BFR-sham). Each of the two treatment arms will perform a fixed exercise protocol singularly and in combination with BFR-NMES, and NMES alone. The specific aims of the study are 1) To determine whether self-managed NMES-Exercise program supplemented with a high BFR of 80% LOP (limb occlusion pressure) is significantly more efficacious than NMES-Exercise with low BFR LOP set at 20 mmHG (sham) in improving muscle strength of the lower extremity, daily physical activity and mobility; and 2) To determine whether NMES-Exercise with high LOP BFR therapy improves QOL and PFPS symptoms significantly more than NMES-Exercise with low LOP BFR.
Primary Outcome
Strength of knee extension muscle groups will be measured using the Nicholas Manual Muscle Tester (NMMT). The participant will be positioned with a small towel roll placed distally to support the femur in 90-degree hip flexion. The participant's knee will be placed in 70º knee flexion using a goniometer. The distance from the tibial tuberosity (TT) to the superior aspect of the medial malleolus will be measured. For knee extension, the first measurement will be taken using standard NMMT protoco
Conditions Studied
Interventions
- DEVICE NMES and exercise supplemented with high BFR
- DEVICE NMES and exercise supplemented with low BFR
Study Locations (1)
Kentucky
- Blanchfield Army Community Hospital (BACH) - Fort Campbell North
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-08-04 |
| Est. Completion | 2022-03-31 |
| Phase | NA |
What the finished NCT04086615 record still lists
NCT04086615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 138-participant average among 10 other Patellofemoral Pain Syndrome trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Patellofemoral Pain Syndrome appearing as the primary indexed condition, and to 2 interventions - of which NMES and exercise supplemented with high BFR is the first listed.
NCT04086615 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT04086615 about?
NCT04086615 is a clinical study titled "Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty". The overall objective of this project is to compare two self-managed treatment regimens for PFPS: (1) NMES-Exercise supplemented with high BFR LOP of 80% and (2) NMES Exercise augmented with a low percentage of BFR LOP at 20 mmHG (BFR-sham). Each of the two treatment arms will perform a fixed exerci...
What is the current status of trial NCT04086615?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2020-08-04. Estimated completion is 2022-03-31.
What conditions does trial NCT04086615 study?
This clinical trial studies the following conditions: Patellofemoral Pain Syndrome.
What interventions are being tested in trial NCT04086615?
The interventions under investigation include: NMES and exercise supplemented with high BFR (DEVICE), NMES and exercise supplemented with low BFR (DEVICE).
Who is sponsoring clinical trial NCT04086615?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04086615 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04086615's enrollment target sits among peer trials
84 5th of 10 higher than 6 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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