Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis

NCT01993693 | Terminated

• 2 other identifiers: OA-022012-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the ability of a wearable therapeutic ultrasound device to reduce pain and increase mobility for subjects with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

knee; pain; osteoarthritis; ultrasound

Outcome Measures

Primary Outcomes (1)

• Pain

  Pain will be recorded using the Visual Analogue Scale (VAS).

  Pain will be recorded twice a day, immediately before application of the device and then immediately after the 4 hour treatment.

Secondary Outcomes (1)

• Mobility

  Mobility will be recorded logged every 5 minutes, up to 24 hours a day, by the actigraph that the subject is wearing on their wrist.

Study Arms (2)

Ultrasonic Diathermy Device

EXPERIMENTAL

Therapeutic ultrasound used daily.

Device: Ultrasonic Diathermy Device

Sham Ultrasonic Diathermy Device

PLACEBO COMPARATOR

Sham device that does not deliver ultrasound

Device: Sham Ultrasonic Diathermy Device

Interventions

Ultrasonic Diathermy Device DEVICE

The Ultrasonic Diathermy Device provides low intensity therapeutic ultrasound to musculoskeletal tissues and joints for the purpose of pain relief, relief of muscle spasm, treatment of joint contraction, and local increase of circulation. The device is FDA-cleared for up to 4 hours of continuous use per treatment. It is a stationary hands-free device.

Also known as: sam

Ultrasonic Diathermy Device

Sham Ultrasonic Diathermy Device DEVICE

Sham therapy delivered by Ultrasonic Diathermy Device that appears identical to active device but does not deliver ultrasound

Also known as: Sham

Sham Ultrasonic Diathermy Device

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Individual will be included if they: 1. Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months, 2. are between 35-65 years of age 3. report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment 4. report mobility limitations because of their knee pain 5. are currently not taking any prescription pain medication other than nonsteroidal antiinflammatory drugs (NSAIDs). All pain medication taken during the study should be documented. 6. 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 7. are deemed appropriate by their physician to participate. Individuals will be excluded if they: 1. cannot successfully demonstrate the ability to put on and take off the device 2. are cognitively impaired 3. have bone-on-bone crepitus 4. have severe OA or patients with little to no cartilage on the knee 5. have knee replacement or other surgical intervention 6. take variable prescription medication 7. are non-ambulatory 8. participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening 9. are currently taking neuropathic medications (ie: Neurontin, Lyrica or Topamax) and/or antidepressants (ie: Amitriptyline).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ZetrOZ, Inc.: lead
• State University of New York - Upstate Medical University: collaborator

Study Sites (1)

Upstate Orthopedics

East Syracuse, New York, 13057, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy A. Damron, MD

  SUNY Upstate Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 18, 2015

Record last verified: 2014-06

Locations

US (1)