Back to resultsLong-Duration Ultrasound for Knee Osteoarthritis
Primary Purpose
Osteo Arthritis Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Long duration ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee
Eligibility Criteria
Inclusion Criteria:
- Are you between 35 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?
Sites / Locations
- Orthopedic Foundation
- Medical Pain Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sham Ultrasound Device
Active Ultrasound Device
Arm Description
No ultrasound treatment
Active treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Strengthen
Strength measurement with force meter (Newtons)
Range of motion
Range of Motion measurement with motion machine (Degrees)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03800927
Brief Title
Long-Duration Ultrasound for Knee Osteoarthritis
Official Title
Multi Week Long-Duration Ultrasound for Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZetrOZ, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will receive active and sham devices for the first 12-weeks. Responders to treatment will continue with 12 weeks of additional active treatment.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham Ultrasound Device
Arm Type
Placebo Comparator
Arm Description
No ultrasound treatment
Arm Title
Active Ultrasound Device
Arm Type
Active Comparator
Arm Description
Active treatment
Intervention Type
Device
Intervention Name(s)
Long duration ultrasound
Intervention Description
Low-intensity long duration ultrasound treatment
Primary Outcome Measure Information:
Title
Change in Pain Units on a Numeric Rating Scale (NRS)
Description
NRS on the scale of 1 - 10, 1 being minimum and 10 being maximum, Change was calculate from base line
Time Frame
Average of first week (start of study) to average measure at 24 weeks (end of study)
Secondary Outcome Measure Information:
Title
Function
Description
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)
Time Frame
First week (start of study) to 24 weeks (end of study)
Title
Strengthen
Description
Strength measurement with force meter (Newtons)
Time Frame
First week (start of study) to 24 weeks (end of study)
Title
Range of motion
Description
Range of Motion measurement with motion machine (Degrees)
Time Frame
First week (start of study) to 24 weeks (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Ortiz, MPH, DO
Organizational Affiliation
Medical Pain Consultants
Official's Role
Study Director
Facility Information:
Facility Name
Orthopedic Foundation
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Medical Pain Consultants
City
Dryden
State/Province
New York
ZIP/Postal Code
13053
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.samrecover.com
Description
Class II Medical Device
Learn more about this trial
Long-Duration Ultrasound for Knee Osteoarthritis
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