Long-Duration Ultrasound for Knee Osteoarthritis

Multi Week Long-Duration Ultrasound for Knee Osteoarthritis

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

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: Long duration ultrasound

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ralph Ortiz, MPH, DO; Phone Number: (607) 844-9979; Email: rodoc@gmail.com

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Orthopedic Foundation
  • New York
    • Dryden, New York, United States, 13053
      • Medical Pain Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strengthen	Strength measurement with force meter (Newtons)	First week (start of study) to 24 weeks (end of study)
Function	WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in the scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400)	First week (start of study) to 24 weeks (end of study)
Range of motion	Range of Motion measurement with motion machine (Degrees)	First week (start of study) to 24 weeks (end of study)

Collaborators and Investigators

• Sponsor: ZetrOZ, Inc.
• Investigators: Study Director: Ralph Ortiz, MPH, DO, Medical Pain Consultants

Publications and helpful links

Helpful Links

• Class II Medical Device

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 15, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OA-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes