Long-Duration Ultrasound for Knee Osteoarthritis

NCT ID: NCT03800927

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham Ultrasound Device

No ultrasound treatment

Group Type: PLACEBO_COMPARATOR

Long duration ultrasound

Intervention Type: DEVICE

Low-intensity long duration ultrasound treatment

Active Ultrasound Device

Active treatment

Group Type: ACTIVE_COMPARATOR

Long duration ultrasound

Intervention Type: DEVICE

Low-intensity long duration ultrasound treatment

Interventions

Long duration ultrasound

Low-intensity long duration ultrasound treatment

Intervention Type: DEVICE

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?

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZetrOZ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Ortiz, MPH, DO

Role: STUDY_DIRECTOR

Medical Pain Consultants

Locations

Orthopedic Foundation

Stamford, Connecticut, United States

Medical Pain Consultants

Dryden, New York, United States

Countries

United States

Related Links

https://www.samrecover.com

Class II Medical Device

Other Identifiers

OA-04

Identifier Type: -

Identifier Source: org_study_id