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 assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over an 8-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of LITUS to improve joint function.
Detailed description
This is an 8-week 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 8 weeks, patients will self-apply their assigned treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as at the completion of treatment. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol. Over 120 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
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\^2 with 2.5% Diclofenac patches.
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
Sponsors
ZetrOZ, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2) * Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA * Are between 35-80 years of age * Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment * Report that knee pain negatively affects quality of life * Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study * Are deemed appropriate by their physician or by the study site physician to participate. * Be 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 use or initiate opioid and/or non-opioid analgesic medications. * Be willing to discontinue any other interventional treatment modalities on the knee during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
Exclusion criteria
* Cannot successfully demonstrate the ability to put on and take off the device. * Displays 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. * Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening. * Is pregnant. * Is a prisoner. * Is non-ambulatory (unable to walk). * 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 a known neuropathy (disease of the brain or spinal nerves). * Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage). * Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months * Are currently taking steroids * 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 (Value at 8 Weeks Minus Value at Baseline). | End of 8 weeks | Change in the self described pain units on a scale by patient at baseline and post-treatment. Higher scores mean a worse outcome. |
| Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Value at 8 Weeks Minus Value at Baseline) | End of 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). Higher values represent a worse outcome, and lower values represent 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/cm\^2 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\^2 with 2.5% Diclofenac patches. | 66 |
| SAM Ultrasound Device and SAM 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 SAM patch(0% diclofenac).
Sustained Acoustic Device with 0% Diclofenac Patch: Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches. | 67 |
| Diclofenac Patch Patients wear 2.5% diclofenac patch for 4 hours at least 5 days a week for 8 weeks combined.
2.5% Diclofenac Patches: Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch. | 67 |
| Total | 200 |
Baseline characteristics
| Characteristic | SAM Ultrasound Device and Diclofenac Patch | SAM Ultrasound Device and SAM Patch | Diclofenac Patch | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 15 Participants | 16 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 52 Participants | 51 Participants | 155 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 35 Participants | 41 Participants | 34 Participants | 110 Participants |
| Sex: Female, Male Male | 31 Participants | 26 Participants | 33 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 67 | 0 / 67 |
| other Total, other adverse events | 0 / 66 | 0 / 67 | 0 / 67 |
| serious Total, serious adverse events | 0 / 66 | 0 / 67 | 0 / 67 |
Outcome results
Primary
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain (Value at 8 Weeks Minus Value at Baseline).
Change in the self described pain units on a scale by patient at baseline and post-treatment. Higher scores mean a worse outcome.
Time frame: End of 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 (Value at 8 Weeks Minus Value at Baseline). | -3.7 units on a scale | Standard Error 0.25 |
| SAM Ultrasound Device and SAM Patch | Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain (Value at 8 Weeks Minus Value at Baseline). | -3.02 units on a scale | Standard Error 0.21 |
| Diclofenac Patch | Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain (Value at 8 Weeks Minus Value at Baseline). | -1.61 units on a scale | Standard Error 0.22 |
Primary
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Value at 8 Weeks Minus Value at 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). Higher values represent a worse outcome, and lower values represent a better outcome.
Time frame: End of 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Value at 8 Weeks Minus Value at Baseline) | -23.42 units on a scale | Standard Error 2.1 |
| SAM Ultrasound Device and SAM Patch | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Value at 8 Weeks Minus Value at Baseline) | -23.02 units on a scale | Standard Error 2.12 |
| Diclofenac Patch | Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Value at 8 Weeks Minus Value at Baseline) | -14.55 units on a scale | Standard Error 2.04 |