NCT06562374

Brief Summary

The purpose of this study is to determine the safety and effectiveness (how well it works) of a new experimental ultrasound bath device that uses low frequency ultrasound (LFU) that may or may not help healing.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jul 2024Feb 2027

First Submitted

Initial submission to the registry

July 31, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

July 31, 2024

Last Update Submit

March 5, 2026

Conditions

Osteo Arthritis KneeAge Related OsteoporosisPainKnee Joint Contracture

Keywords

PainOsteo Arthritis KneeKneeUltrasoundJoint mobility

Outcome Measures

Primary Outcomes (1)

  • Participant-Reported Safety and Efficacy Following Use of Investigational Device

    The number of participants who report any device-related safety concerns following use of the investigational non-significant risk device, as assessed by participant-reported surveys.

    From device use through completion of the final study visit, up to one year

Secondary Outcomes (1)

  • Participants with Osteoarthritic Joints Reaction to the LFU

    one year

Study Arms (1)

Low Frequency Ultrasound (LFU) Intervention

EXPERIMENTAL

Subjects will be given ultrasound at a frequency of 33 kHz with a program of 1.6 seconds on and 1.6 seconds off for 30 min at either a power level of 4 or 10 Pascals to determine which power level is optimal for osteoarthritis. Follow up visits after two-three days will be used to continue therapy.

Device: Low Frequency Ultrasound Therapy

Interventions

Low Frequency Ultrasound TherapyDEVICE

The ultrasound will be delivered at a frequency of 33 kHz at power levels of 4-10 Pascals with a program of 1.6 seconds on and 1.6 seconds off. The generators will be encased in epoxy within the Osteoarthritis baths. The intervention will be repeated on every second or third day to allow time for healing

Low Frequency Ultrasound (LFU) Intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
  • Adults at least ≥40 years of age at the time of consent.
  • Chronic knee pain within the past 6 months.

You may not qualify if:

  • Any other arthritic condition clinically classified under ACR guidelines as different from an Osteoarthritic disorder.
  • Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
  • History of replacement surgery, acupuncture therapy on the joint/knee under study within the past 6 months, or systemic corticosteroids within the study period and previous 30 days.
  • Subject's vitals are unstable or not in range for a safe study visit.
  • History of fecal incontinence.
  • Vomiting/Diarrheal illness within the past 7 days or at any time during the study.
  • Any clinically significant rash or formation of rashes or open sores, boils or infected wounds two weeks prior to or during the study.
  • Laboratory evidence of infection or colonization with multidrug resistant pathogens in the past 90 days (eg. vancomycin resistant enterococcus, methicillin-resistant Staphylococcus, Candida auris, extended- spectrum beta lactamase bacteria)
  • History of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
  • Females who are pregnant or lactating.
  • Inability to comply with study protocol.
  • Incarcerated individuals.
  • Non-English speaking subjects.
  • Participant's weight must be \</= 350 lbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 777555, United States

Location

MeSH Terms

Conditions

OsteoporosisPain

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Blackwell

    University of Texas Medical Branch, Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 20, 2024

Study Start

July 31, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

US(1)