CompletedNot Applicable

Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty

United States84 participantsStarted 2020-08-04

Plain-language 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.

Who can participate

Age range

18 Years – 44 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. diagnosed with knee pain, categorized as anterior or retropatellar in one or both knees;
. self-reported difficulty performing at least two or more of the following activities associated with knee pain: prolonged sitting, stair climbing, running, jumping, and repetitive movements such as kneeling or squatting or stooping;
. military service member at the time of diagnosis and length of study;
. age ≥18 and \<45 years; and
. able to provide freely given informed consent.

Exclusion criteria

. fracture or injury to external knee structures such that knee extension or flexion is impaired;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Lower Extremity Muscle Strength- Extension

Timeframe: Time Frame: 9 weeks

Change in Lower Extremity Muscle Strength- Flexion

Timeframe: Time Frame: 9 weeks

Change in Lower Extremity Muscle Strength- Hip Posterolateral Stabilizer

Timeframe: Time Frame: 9 weeks

Change in Mobility- Timed Stair Climb Test

Timeframe: Time Frame: 9 weeks

Change in Mobility- Forward Step-Down Test

Timeframe: Time Frame: 9 weeks

Change in Mobility- 30-Second Chair Stand Test

Timeframe: Time Frame: 9 weeks

Change in Mobility- 6-Minute Walk Test

Timeframe: Time Frame: 9 weeks

Trial details

NCT IDNCT04086615

SponsorUniversity of Tennessee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

View on ClinicalTrials.gov More Patellofemoral Pain Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 44 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. diagnosed with knee pain, categorized as anterior or retropatellar in one or both knees;
. self-reported difficulty performing at least two or more of the following activities associated with knee pain: prolonged sitting, stair climbing, running, jumping, and repetitive movements such as kneeling or squatting or stooping;
. military service member at the time of diagnosis and length of study;
. age ≥18 and \<45 years; and
. able to provide freely given informed consent.

Exclusion criteria

. fracture or injury to external knee structures such that knee extension or flexion is impaired;

What they're measuring

Change in Lower Extremity Muscle Strength- Extension

Timeframe: Time Frame: 9 weeks

Change in Lower Extremity Muscle Strength- Flexion

Timeframe: Time Frame: 9 weeks

Change in Lower Extremity Muscle Strength- Hip Posterolateral Stabilizer

Timeframe: Time Frame: 9 weeks

Change in Mobility- Timed Stair Climb Test

Timeframe: Time Frame: 9 weeks

Change in Mobility- Forward Step-Down Test

Timeframe: Time Frame: 9 weeks

Change in Mobility- 30-Second Chair Stand Test

Timeframe: Time Frame: 9 weeks

Change in Mobility- 6-Minute Walk Test

Timeframe: Time Frame: 9 weeks