Effects of Electrical Stimulation on Osteoarthritis of the Knee
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| ClinicalTrials.gov Identifier: TBD |
| Recruitment Status: Not Yet Started First Posted: July 17th, 2019 Last Update Posted: July 17th, 2019 |
Sponsor: OrthoStim a Leonhardt’s Launchpads Co.
Information provided by: OrthoStim
Study Details
Study Description
The purpose of this study is to find out whether electrical stimulation can reduce knee pain and increase function in people with osteoarthritis of the knee.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis, Knee | Device: OrthoStim Mettler Bioelectric Stimulator FDA 510 K113017 6/26/2012 FDA Link |
Post Market |
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Enrollment: | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Electrical Stimulation on Osteoarthritis of the Knee |
| Study Start Date: | September 15th, 2019 |
| Primary Completion Date: | TBD |
| Study Completion Date: | TBD |
Arms and Interventions
| Arm | Intervention |
|---|---|
| Experimental | Device: OrthoStim Mettler Bioelectric Stimulator 20–30 minute sessions: 3x/week for 3 weeks, 2x/week for 3 weeks, 1x/week for 2 weeks Other Name: Noninvasive Interactive Neurostimulation |
| Placebo Comparator | Device: OrthoStim Mettler Bioelectric Stimulator Same schedule as experimental group Other Name: Noninvasive Interactive Neurostimulation |
Outcome Measures
Primary: Knee Pain (Baseline, Week 4, Week 8, Week 12)
Secondary:
- Knee function
- Knee stiffness
- Patient global assessment
- Health-related quality of life
Eligibility Criteria
Ages: 50 years and older
Sex: All
Healthy volunteers: No
Inclusion Criteria:
- 50 years of age or older
- Diagnosis of primary osteoarthritis of the knee
- Knee pain ≥ 6 months
- Moderate or greater pain
- Willing to follow protocol
Exclusion Criteria:
- Implants incompatible with electrical stimulation
- Other inflammatory joint diseases
- Pregnancy or breastfeeding
- Recent injections or surgery
- Significant knee injury or other interfering conditions
Contacts and Locations
NCT00601497
Location: United States, California
Sponsors and Collaborators
OrthoStim, Los Angeles, CA
Investigators
Principal Investigator: Dr. Carlos Prieto, Hoag Orthopedic Hospital Irvine, CA
More Information
Responsible Party: Dr. Leslie Miller, Chief Medical Officer, OrthoStim
First Posted: July 17th, 2019
Last Updated: July 17th, 2019