Arthritis, Osteo Arthritis Knee
Conditions
Keywords
low-intensity ultrasound, drug delivery, sonophoresis, transdermal drug delivery, Non-Steroidal anti-inflammatory Drugs, sustained acoustic medication, low intensity continuous ultrasound
Brief summary
The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II and stage III knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase function of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.
Detailed description
This is a seven day study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. The class-II device, sam® has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 6 days, patients will self-apply the wearable SAM device with diclofenac patch to their affected knee for 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as 30 minutes, 2-hours and 4-hours after applying the device. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol. Up to 32 subjects will be recruited from neighboring communities to the study sites. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals.
Interventions
COMBINATION_PRODUCTSustained Acoustic Device with 1% Diclofenac patch
Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device
Sponsors
ZetrOZ, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months * Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA * 45-85 years of age * Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding enrollment * Report that knee pain negatively affects quality of life * Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound 1% diclofenac gel provided to the subject at the initiation of the study * Deemed appropriate by their physician or by the study site physician to participate
Exclusion criteria
* Cannot successfully demonstrate the ability to put on and take off the device * Display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions. * Have severe OA or have little to no cartilage in the knee * Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months * Are non-ambulatory * Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening * Modify their medications during the course of the study (medications and doses must remain constant throughout the study) * Currently taking steroids * Have contraindication to radiograph * Have a secondary cause of arthritis (metabolic or inflammatory)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline | 7 days | Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores, Ranging From 0 Being No Difficulty to 2400 Being Extreme Difficulty, From Baseline | 7 days | WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in the scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: SAM Ultrasound and Diclofenac Patch Patients receive treatment from the SAM Ultrasonic Diathermy Device for 4 hours every day for 7 days combined with 1% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 1% Diclofenac patch: Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch
Other Names:
* ZetrOZ ultrasound device
* wearable ultrasound device
* long duration ultrasound
* LITUS device
* long duration low intensity device | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Experimental: SAM Ultrasound and Diclofenac Patch | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 17 Participants | — |
| Age, Categorical Between 18 and 65 years | 15 Participants | — |
| Age, Continuous | 53.6 YEARS STANDARD_DEVIATION 8.8 | — |
| Numeric Rating Scale (NRS) | 4.06 Pain Units on a Scale STANDARD_DEVIATION 2.39 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 32 participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
| WOMAC | 1168 Units on a Scale STANDARD_DEVIATION 528 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Change in the self described pain units on a scale by patient at baseline and post-treatment on the range of 0 - 10, 0 being the least pain and 10 being the worst pain.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: SAM Ultrasound and Diclofenac Patch | Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline | 2.00 pain units on a scale | Standard Deviation 2.41 |
p-value: <0.001ANOVA
Secondary
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores, Ranging From 0 Being No Difficulty to 2400 Being Extreme Difficulty, From Baseline
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in the scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400)
Time frame: 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental: SAM Ultrasound and Diclofenac Patch | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores, Ranging From 0 Being No Difficulty to 2400 Being Extreme Difficulty, From Baseline | -353 scores on a scale |
p-value: <0.001t-test, 1 sided