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Long-Duration Ultrasound for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03800927
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
ZetrOZ, Inc.

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

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Device: Long duration ultrasound Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi Week Long-Duration Ultrasound for Knee Osteoarthritis
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Sham Ultrasound Device
No ultrasound treatment
Device: Long duration ultrasound
Low-intensity long duration ultrasound treatment

Active Comparator: Active Ultrasound Device
Active treatment
Device: Long duration ultrasound
Low-intensity long duration ultrasound treatment




Primary Outcome Measures :
  1. Pain Reduction: NRS [ Time Frame: Average of first week (start of study) to average measure at 24 weeks (end of study) ]
    NRS Pain Reduction From Baseline


Secondary Outcome Measures :
  1. Function [ Time Frame: First week (start of study) to 24 weeks (end of study) ]
    WOMAC Scale

  2. Strengthen [ Time Frame: First week (start of study) to 24 weeks (end of study) ]
    Strength measurement with force meter (Newtons)

  3. ROM [ Time Frame: First week (start of study) to 24 weeks (end of study) ]
    Range of Motion measurement with motion machine (Degrees)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are you between 35 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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800927


Contacts
Contact: Ralph Ortiz, MPH, DO (607) 844-9979 rodoc@gmail.com

Locations
United States, Connecticut
Orthopedic Foundation Recruiting
Stamford, Connecticut, United States, 06905
Contact: Stephanie Petterson, PHD         
United States, New York
Medical Pain Consultants Recruiting
Dryden, New York, United States, 13053
Contact: Ralph Ortiz, DO, MPH         
Sponsors and Collaborators
ZetrOZ, Inc.

Responsible Party: ZetrOZ, Inc.
ClinicalTrials.gov Identifier: NCT03800927     History of Changes
Other Study ID Numbers: OA-04
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases