Long-Duration Ultrasound for Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

Multi Week Long-Duration Ultrasound for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800927
• Other study ID #: OA-04
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2023
• Source: ZetrOZ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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?

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Long duration ultrasound
Low-intensity long duration ultrasound treatment

Locations

Country	Name	City	State
United States	Medical Pain Consultants	Dryden	New York
United States	Orthopedic Foundation	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ZetrOZ, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Strengthen	Strength measurement with force meter (Newtons)	First week (start of study) to 24 weeks (end of study)
Secondary	Range of motion	Range of Motion measurement with motion machine (Degrees)	First week (start of study) to 24 weeks (end of study)

External Links

•   Class II Medical Device