Clinical trial NCT02243332: Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain
Official title: Dynamic Quadriceps Muscle Stimulation for Treatment of Patellofemoral Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Anterior Knee Pain Syndrome
Keywords: Knee
Pain
Joint
Rehabilitation
Patellofemoral Pain Syndrome
Anterior Knee Pain Syndrome
Knee Pain
Quadriceps
Lead sponsor: Articulate Labs
Sponsor class: INDUSTRY
Collaborators: name: University of Texas at Austin
First posted: 2014-09-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this small, pilot study is to evaluate a novel device that uses neuromuscular electrical stimulation to assist quadriceps muscles as a user walks. This study will involve use of this device on individuals with patellofemoral pain, a relatively common injury among active people, to see if quadriceps stimulation could mitigate disparities in quadriceps activation timing that may indirectly lead to knee pain.

Detailed description: The interventional device will be tested with 20 women aged 18-40 with evidence of patellofemoral pain syndrome (PFPS) and without any co-morbidities that would confound data or contraindications for NMES use. All participants will be enrolled at a single site (Developmental Motor Lab at the University of Texas), and all of a single participant's testing will be complete within a single day with no requirement for follow-up or long-term participation. Participants will have their gait and quadriceps muscle activation patterns evaluated through four six-minute walk tests (6MWT). The first 6MWT will be without a device, second with a device worn but not activated, third with a device activated and stimulating quadriceps musculature, and the fourth without a device.

Primary Objective: The purpose of this study is to investigate whether electrical stimulation of the vastus medalis (VM) and/or vastus lateralis (VL) to establish coactivation of these muscles during terminal swing phase impacts severity of PFPS symptoms

Secondary Objectives: Secondary purposes for this study include evaluating KneeStim and seeing if there is any evidence of proof of concept in two main areas:

KneeStim as a therapeutic device that may assist individuals with joint rehabilitation KneeStim's on-board operating system and motion tracking system as an effective way to monitor joint kinematics.

This pilot study has a prospective, controlled, single-center design. Participants and investigators will not be blinded to the treatment. Individuals who evaluate the motion-tracking data between VICON and KneeStim will not be informed which data set aligns with which treatment.

Eligibility criteria: Inclusion Criteria:

* Aged 18-40 years
* Symptomatic PFPS on Patella Glide Test, Patella Tilt Test, and Patellar Apprehension Test.

Exclusion Criteria:

* Rheumatoid arthritis or inflammatory arthritis as assessed by licensed physician
* Use of walking aids other than a cane more than 50% of the time in ambulation
* Diagnosed knee disorder other than patellofemoral syndrome
* Pacemaker use, unstable angina, or decompensated heart failure
* Knee replaced in preceding 12 months or replacement planned within 6 months
* Moderate to severe dementia
* Pregnancy (self report)
* Altered sensation at the knee such that the patient is unable to perceive the presence of pinprick.
* Use of intra-articular viscosupplementation or steroid injection within preceding 2 months.
* Use of chronic anticoagulation medication.
* Movement-limiting pain in the back, hip, ankle, or foot of either lower limb.

Primary outcomes:
measure: Measured Quadriceps Musculature Co-Contraction
timeFrame: 20, 40, 60, 80 minutes from start of single-day testing
Secondary outcomes:
measure: Anterior Knee Pain
timeFrame: 20, 40, 60, 80 minutes from start of single-day testing
measure: Device Joint Model Accuracy
timeFrame: 20, 40, 60, 80 minutes from start of single-day testing
Other outcomes:
Locations:
city: Austin
country: United States
facility: Developmental Motor Control Lab; University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Lisa Griffin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: