Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
- Summary
- The purpose of this study is to assess the ability of long-duration low intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over a 24-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of LITUS to improve joint function.
- Short title
- Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
- Official title
- Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-06-26
- First posted
- 2024-02-14
- Registry last updated
- 2026-06-30
- Primary completion date
- 2026-06-26
- Start date
- 2024-10-01
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- ZetrOZ, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06257537
- ClinicalTrials.gov ID
- NCT06257537
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Timeframe: Through study completion, average of 24 weeks.
Change in the self-described pain units on a scale by patient at baseline and post-treatment.
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timeframe: Through study completion, average of 24 weeks.
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).
Change in Global Rating of Change (GROC) on a Scale (-7 to +7)
Timeframe: Through study completion, average of 24 weeks.
Subject-reported change in overall pain on a scale, -7 = worst, +7 = best.
Change in the Pain & Sleep Questionnaire (PSQ-3)
Timeframe: Through study completion, average of 24 weeks.
Subject-reported rating of impact of pain on sleep on a scale from 0 no impact, to 100 greatest impact.
Change in Depression Anxiety Stress Scale (DASS21)
Timeframe: Through study completion, average of 24 weeks.
Subject-reported measures of depression, anxiety, and stress on a scale of 0-3, 0 being not applicable, 1 meaning applicable to some degree, 2 meaning applicable often, and 3 meaning applicable most of the time. Questions are divided into three categories: depression, anxiety, and stress.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 50 Years
- Maximum age
- 85 Years
- Healthy volunteers
- Yes
- Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
- Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- Are between 50-85 years of age
- Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
- Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
- Are deemed appropriate by their physician or by the study site physician to participate.
- Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
- Not use or initiate use of opioid and/or non-opioid analgesic medications.
- Be willing to discontinue any other interventional treatment modalities on the knee during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
- Cannot successfully demonstrate the ability to put on and take off the device.
- Displays 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.
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Is pregnant.
- Is a prisoner.
- Is non-ambulatory (unable to walk).
- Has a pacemaker.
- Has a malignancy in the treatment area.
- Has an active infection, open sores, or wounds in the treatment area.
- Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
- Has a known neuropathy (disease of the brain or spinal nerves).
- Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months.
- Are currently taking steroids.
- Have any contraindication to radiograph.
- Have a secondary cause of arthritis (metabolic or inflammatory).
- Orthopaedic FoundationStamford, United States
- ZetrOZ SystemsTrumbull, United States
- Cayuga Medical Center - Medical Pain ConsultantsDryden, United States
- Related resource (www.samrecover.com)