Phase 2
Completed N=140
A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis
Osteoarthritis, Degenerative
Source: ClinicalTrials.gov NCT02034409 ↗
Enrolled (actual)
140
Serious AEs
24.2%
Results posted
Oct 2021
Primary outcomePrimary: Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness — 37; 38; 18; 16 Participants
Summary
The purpose of this exploratory trial is to investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness |
37; 38; 18; 16 | — |
| PRIMARY Co-Primary Measure: b) Disease Modification as Measured by Change From Baseline in Cartilage Thickness of the Central Medial Femoral Condyle Disease |
-42.2; -73.8 | — |
| SECONDARY Change From Baseline in WOMAC Stiffness Subscale Score |
-33.6; -27.7; -49.8; -37.1 | — |
| SECONDARY Change From Baseline in WOMAC Pain Subscale Score |
-84.2; -91.4; -117.1; -93.4 | — |
| SECONDARY Change From Baseline in WOMAC Functional Limits Subscale Score |
-285.2; -241.1; -407.3; -283.1 | — |
| SECONDARY Change From Baseline in Total WOMAC Score |
-403.0; -360.2; -574.1; -413.6 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Status |
-16.6; -15.0; -23.7; -17.6 | — |
| SECONDARY Change From Baseline in Investigator Global Assessment of Disease Status |
-18.4; -15.8; -28.6; -18.9 | — |
| SECONDARY Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Constant Pain Subscale |
-14.6; -12.4; -18.4; -13.7 | — |
| SECONDARY Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Intermittent Pain Subscale |
-17.7; -13.4; -20.2; -15.0 | — |
| SECONDARY Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Total Pain Score |
-16.3; -12.9; -19.4; -14.4 | — |
| SECONDARY Number of Participants Discontinuing the Study Device Due to an Adverse Device Event |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 40 years of age or older, and a US Military Veteran
- Clinical symptoms of osteoarthritis for at least 6 months
- Pain in the index knee on motion or weight bearing for the majority of days during the month before screening
- Clinical diagnosis of primary osteoarthritis of the knee based on clinical and radiographic criteria
- American Rheumatism Association Functional Class I, II, or III
- Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception
Exclusion Criteria
- Concurrent medical/arthritis condition(s), or any other illness per the opinion of the investigator, that could interfere with the evaluation of pain or efficacy
- Spine or hip pain of significant magnitude
- History of significant ligament or meniscal injury of the index joint requiring surgical repair
- Arthroscopy of the index knee within 6 months of study entry
- Unable to undergo MRI of the knee
- Pregnancy or lactation
- Corticosteroid treatment within 1 to 3 months prior to study entry
- Intra-articular injection of hyaluronic acid or congeners to the index knee within 6 months of study entry
- Use of excluded therapy(ies) prior to study entry
- Use of disease modifying anti-rheumatic medications and chronic tetracycline or its derivatives
- Exposure to glucosamine, chondroitin sulfate, or any other investigational treatment, within 1 month of study entry
- Use of any medical therapy, complementary or alternative regimens for the treatment of osteoarthritis within 7 days prior to study entry
- Initiation of physical therapy or muscle conditioning program to the lower extremities within 2 months within 2 months prior to study entry
- Unlikely to comply with study requirements
Data sourced from ClinicalTrials.gov (NCT02034409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.