Clinical trial NCT03800927: Long-Duration Ultrasound for Knee Osteoarthritis
Official title: Multi Week Long-Duration Ultrasound for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: ZetrOZ, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive active and sham devices for the first 12-weeks. Responders to treatment will continue with 12 weeks of additional active treatment.
Primary purpose: TREATMENT

Brief summary: This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain.


Eligibility criteria: Inclusion Criteria:

* Are you between 18 and 80 years of age (inclusive)?
* Can you speak, read, and write in English?
* Do you have knee pain that has lasted at least 3 months?
* Are you willing and able to self-administer the ultrasound device daily within your place of residence or during normal daily activity?
* Are you willing to keep all pain medications stable and discuss with the investigator any needs to change medications during the study period? This may include drugs administered topically, orally, transdermally, or by injection.
* Are you willing to document usage of any medications during the study period?
* Do you agree to discontinue all other interventional treatment modalities on the lower back during the study? (e.g., transcutaneous electric nerve stimulation \[TENS\], electronic muscle stimulation, traditional ultrasound, massage therapy, chiropractic services)
* On a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (pain as bad as you can imagine), how would you rate your average pain over the past week? Pain must be ≥4 for the subject to be enrolled in this study. This criterion will be assessed by self-report at Visit 1.

Exclusion Criteria:

* Have you participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening?
* Are you pregnant?
* Are you a prisoner?
* Are you non-ambulatory (unable to walk)?
* Do you have a pacemaker?
* Do you have a malignancy in the treatment area?
* Do you have an active infection, open sores, or wounds in the treatment area?
* Do you have impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia?
* Do you have a known neuropathy (disease of the brain or spinal nerves)?
* Do you have a hereditary disposition (tendency) for excessive bleeding (hemorrhage)?
* Do you have peripheral artery disease?
* Does the subject 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?

Primary outcomes:
measure: Change in Pain Units on a Numeric Rating Scale (NRS)
timeFrame: Average of first week (start of study) to average measure at 24 weeks (end of study)
Secondary outcomes:
measure: Function
timeFrame: First week (start of study) to 24 weeks (end of study)
measure: Strengthen
timeFrame: First week (start of study) to 24 weeks (end of study)
measure: Range of motion
timeFrame: First week (start of study) to 24 weeks (end of study)
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Orthopedic Foundation
state: Connecticut
city: Dryden
country: United States
facility: Medical Pain Consultants
state: New York
Study officials:
affiliation: Medical Pain Consultants
name: Ralph Ortiz, MPH, DO
role: STUDY_DIRECTOR
References: