Effects of Electrical Stimulation on Osteoarthritis of the Knee
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| ClinicalTrials.gov Identifier: TBD |
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Recruitment Status : Not Yet Started
First Posted : July 17th, 2019
Last Update Posted : July 17th, 2019
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Sponsor:
OrthoStim a Leonhardt’s Launchpads Co.
Information provided by:
OrthoStim
- Study Details
Brief Summary:
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 https://www.accessdata.fda.gov/cdrh_docs/pdf11/K113017.pdf | Post Market |
| Study Type : | Interventional (Clinical Trial) |
| Actual 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 |
| Actual Primary Completion Date : | TBD |
| Actual Study Completion Date : | TBD |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics: Osteoarthritis
MedlinePlus related topics: Osteoarthritis
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 | Device: OrthoStim Mettler Bioelectric Stimulator
20-30 minute device sessions on the following schedule: 3 times per week for 3 weeks, then 2 times per week for 3 weeks, then 1 time per week for 2 weeks.
Other Name: Noninvasive Interactive Neurostimulation
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| Placebo Comparator: 2 | Device: OrthoStim Mettler Bioelectric Stimulator
20-30 minute device sessions on the following schedule: 3 times per week for 3 weeks, then 2 times per week for 3 weeks, then 1 time per week for 2 weeks.
Other Name: Noninvasive Interactive Neurostimulation
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Primary Outcome Measures :
- Knee Pain [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]
Secondary Outcome Measures :
- Knee function [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]
- Knee stiffness [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]
- Patient global assessment [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]
- Health-related quality of life [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 50 years of age or older
- Diagnosis of primary osteoarthritis of the knee (as defined by American College of Rheumatology criteria)
- Knee pain of at least six months duration
- Moderate or greater knee pain (defined as a score of 3 or greater on an 11 point numeric pain rating scale) for most days in the last month
- Willing to abide by protocol and treatment schedule.
Exclusion Criteria:
- Implants, such as pacemaker, TENS, or insulin pump, incompatible with electrical stimulation
- Uncontrolled concomitant disease affecting the knee, such as: rheumatoid arthritis, systemic lupus erythema, psoriatic arthritis
- Pregnant or breast-feeding
- Intra-articular corticosteroid or hyaluronic acid injection into the knee within 3 months preceding study
- Arthroscopy of the knee within the past year
- Significant injury to the knee within the past 6 months
- Use of assistive devices other than a cane or knee brace
- Disease of spine or other lower extremity joints of sufficient degree to affect assessment of the knee
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601497
Locations
| United States, California | |
Sponsors and Collaborators
OrthoStim, Los Angeles, CA
Investigators
| Principal Investigator: Proposed > Dr. Carlos Prieto, | Hoag Orthopedic Hospital Irvine, CA |
| Responsible Party: | Dr. Leslie Miller, Chief Medical Officer, OrthoStim a Leonhardt’s Launchpads Co. |
| ClinicalTrials.gov Identifier: | TBD |
| Other Study ID Numbers: | TBD |
| First Posted: | July 17th, 2019 |
| Last Update Posted: | July 17th, 2019 |
| Last Verified: | July 17th, 2019 |
Additional relevant MeSH terms:
| Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |