Long-Duration Ultrasound for Knee Osteoarthritis

NCT03800927 | Completed DMC FDA Device

• 1 other identifier: OA-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Change in Pain Units on a Numeric Rating Scale (NRS)

  NRS on the scale of 1 - 10, 1 being minimum and 10 being maximum, Change was calculate from base line

  Average of first week (start of study) to average measure at 24 weeks (end of study)

Secondary Outcomes (3)

• Function

  First week (start of study) to 24 weeks (end of study)

• Strengthen

  First week (start of study) to 24 weeks (end of study)

• Range of motion

  First week (start of study) to 24 weeks (end of study)

Study Arms (2)

Sham Ultrasound Device

PLACEBO COMPARATOR

No ultrasound treatment

Device: Long duration ultrasound

Active Ultrasound Device

ACTIVE COMPARATOR

Active treatment

Device: Long duration ultrasound

Interventions

Long duration ultrasound DEVICE

Low-intensity long duration ultrasound treatment

Active Ultrasound Device; Sham Ultrasound Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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?

Sponsors & Collaborators

• ZetrOZ, Inc.: lead

Study Sites (2)

Orthopedic Foundation

Stamford, Connecticut, 06905, United States

Location

Medical Pain Consultants

Dryden, New York, 13053, United States

Location

Related Links

• Class II Medical Device

Study Officials

• Ralph Ortiz, MPH, DO

  Medical Pain Consultants

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive active and sham devices for the first 12-weeks. Responders to treatment will continue with 12 weeks of additional active treatment.

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: January 11, 2019
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)