Knee Osteoarthritis
Conditions
Keywords
Non-Steroidal Anti-Inflammatory Drugs, Sustained Acoustic Medication, Low-Intensity Continuous Ultrasound
Brief summary
The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.
Interventions
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
DRUG1% Diclofenac Topical Gel
Topical pain-relief gel
Sponsors
ZetrOZ, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 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 * 35-80 years of age * Report a frequent pain score between 4-7 (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 gel provided to the subject at the initiation of the study * Deemed appropriate by their physician or by the study site physician to participate * Willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device * Not initiate use of opioid and/or non-opioid analgesic medications * Willing to discontinue any other interventional treatment modalities on the knee during the study period
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 * Is non-ambulatory (unable to walk) * Is pregnant * Is a prisoner * Has a pacemaker * Has a malignancy in the treatment area * Has an active infection, open sores, or wounds in the treatment area * Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia * Has known neuropathy * Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage) * 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 | 8 weeks | 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. |
| Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline | 8 weeks | WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SAM Ultrasound Device and Diclofenac Patch Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches. | 20 |
| SAM2 Ultrasound Device and Diclofenac Patch Patients receive treatment from the wireless SAM Ultrasonic Diathermy Device for 1 hour at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Sustained Acoustic Device with 2.5% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches. | 20 |
| Topical Pain-Relief Gel Patients apply topical 1% diclofenac gel three times per day, at least 5 days per week for 8 weeks.
1% Diclofenac Topical Gel: Topical pain-relief gel | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | SAM Ultrasound Device and Diclofenac Patch | SAM2 Ultrasound Device and Diclofenac Patch | Topical Pain-Relief Gel |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 20 Participants | 20 Participants | 20 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Sex: Female, Male Female | 30 Participants | 10 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 30 Participants | 10 Participants | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
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: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch | Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline | -3.56 units on a scale | Standard Error 0.37 |
| SAM2 Ultrasound Device and Diclofenac Patch | Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline | -3.29 units on a scale | Standard Error 0.41 |
| Topical Pain-Relief Gel | Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline | -1.00 units on a scale | Standard Error 0.37 |
Primary
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96). A higher score is considered a worse outcome, and a lower score is considered a better outcome.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline | -15.71 units on a scale | Standard Error 2.31 |
| SAM2 Ultrasound Device and Diclofenac Patch | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline | -16.71 units on a scale | Standard Error 4.87 |
| Topical Pain-Relief Gel | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline | -5.72 units on a scale | Standard Error 2.31 |