Knee Injuries, Knee Osteoarthritis
Conditions
Keywords
Knee pathology
Brief summary
The objective of this study is complete a longitudinal cross-over clinical study to investigate the effect of treatments for knee pathology, including cutaneous stimulation (skin vibration and soft knee brace), on locomotion tasks (i.e. walking, jogging, stair ascending and descending), muscle function, and pain/function.
Interventions
DEVICECutaneous Stimulation
A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
DEVICEKnee Sleeve
Commercially-available knee sleeve.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be told only that we are comparing two types of treatment for their knee pain.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 * Ambulatory * Symptomatic knee pain ≥ 3/10 on most of the past 30 days * Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3) * Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day) * Committed to not starting any new therapies for knee condition during the trial, other than rescue pain medication.
Exclusion criteria
* Use of walking aid (e.g. cane, crutch, walker, or wheelchair) * BMI ≥ 35 kg/m2 * Injection in the affected knee during the previous three months * Known neuropathy due to diabetes or other causes * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Knee Flexion Moment (%Bw*Ht) | Baseline and 4 week follow-up | Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight\*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Baseline and 4 week follow-up | Within-subject change (follow-up - baseline) in pain (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. |
| Change in Function | Baseline and 4 week follow-up | Within-subject change (follow-up - baseline) in function (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. |
| Change in Symptoms | Baseline and 4-week follow-up | Within-subject change (follow-up - baseline) in symptoms (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Subjects received two treatments assigned in random order: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period.
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
Knee Sleeve: Commercially-available knee sleeve. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 11.4 |
| KOOS Function | 72.31 units on a scale STANDARD_DEVIATION 15.98 |
| KOOS Pain | 66.25 units on a scale STANDARD_DEVIATION 13.4 |
| KOOS Symptoms | 59.8 units on a scale STANDARD_DEVIATION 15.58 |
| Peak Knee Flexion Moment (%Bw*Ht) | 3.14 %Bw*Ht STANDARD_DEVIATION 1.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 2 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Change in Peak Knee Flexion Moment (%Bw*Ht)
Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight\*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline.
Time frame: Baseline and 4 week follow-up
Population: Participants completing the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A (Cutaneous Stimulation) | Change in Peak Knee Flexion Moment (%Bw*Ht) | 0.197 %Bw*Ht | Standard Deviation 0.374 |
| Treatment B (Knee Sleeve) | Change in Peak Knee Flexion Moment (%Bw*Ht) | 0.018 %Bw*Ht | Standard Deviation 0.725 |
p-value: 0.005t-test, 2 sided
p-value: 0.64t-test, 2 sided
Secondary
Change in Function
Within-subject change (follow-up - baseline) in function (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: Baseline and 4 week follow-up
Population: Participants completing the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A (Cutaneous Stimulation) | Change in Function | 4.48 units on a scale | Standard Deviation 12.56 |
| Treatment B (Knee Sleeve) | Change in Function | 0.64 units on a scale | Standard Deviation 7.903 |
Secondary
Change in Pain
Within-subject change (follow-up - baseline) in pain (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: Baseline and 4 week follow-up
Population: Participants completing the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A (Cutaneous Stimulation) | Change in Pain | 1.476 units on a scale | Standard Deviation 12.286 |
| Treatment B (Knee Sleeve) | Change in Pain | -0.391 units on a scale | Standard Deviation 9.714 |
Secondary
Change in Symptoms
Within-subject change (follow-up - baseline) in symptoms (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: Baseline and 4-week follow-up
Population: Participants completing the study protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A (Cutaneous Stimulation) | Change in Symptoms | 3.571 units on a scale | Standard Deviation 9.47 |
| Treatment B (Knee Sleeve) | Change in Symptoms | -0.781 units on a scale | Standard Deviation 10.876 |