Status:
COMPLETED
Evaluation of NMES Therapy for Pain Relief Associated With Knee Osteoarthritis
Lead Sponsor:
CyMedica Orthopedics, Inc
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
A roll-over study of the current CM-2019 trial to assess the same preplanned outcomes of CM-2019 at 14 weeks.
Detailed Description
This roll-over study is designed as a 14-week treatment continuation from CM-2019 (parent study), a randomized, sham controlled, double-blind, multi-center study trial to evaluate the efficacy of CyMe...
Eligibility Criteria
Inclusion
- Subject must provide a signed informed consent for CM-2019R. The subject will be provided with a copy of the signed Informed Consent upon signature.
- Currently enrolled in the parent trial CM-2019 or have successfully completed the parent trial within 21 days of enrollment in the roll-over trial.
- Willing and able to continue parent trial study treatment.
- Pregnancy test, if it has been \>14 days since completion of the parent trial.
- Subject must continue to be willing to refrain from receiving knee intra-articular injections of steroids, knee intra-articular injections of hyaluronic acid, opioids, and analgesics (except for acetaminophen up to 3000 mg/day or an equivalent) for the duration of the study.
- Subject must continue to be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as pain medication for the duration of the study.
- Subject must continue to be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
- Subject must continue to be willing to stop receiving knee physical therapy of the target knee for the duration of the study.
- Subject must continue be willing to stop wearing any knee unloader brace of the target knee for the duration of the study.
- Subjects must be willing and able to comply with all study procedures for the duration of the clinical study
Exclusion
- Subjects with a new diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active gout, knee joint infection, Lyme disease, SLE, etc.) since parent trial enrollment.
- Subjects with a new diagnosis of severe neuropathy condition and under medication for treatment of the condition since parent trial enrollment.
- Subjects with a new diagnosis of fibromyalgia since parent trial enrollment.
- Subjects who have had an injury or an acute traumatic injury to the target knee since parent trial enrollment.
- Subject must NOT have had arthroscopy of the target knee since parent trial enrollment.
- Subjects who have had treatment of the target knee with intra-articular injections of steroids since parent trial enrollment. Subjects who have had intra-articular injections of hyaluronic acid since parent trial enrollment.
- Subjects who have a scheduled surgery on the target knee within the study period. (Subjects that are contemplating the surgery can be included.)
- Subjects who have used electrotherapy or acupuncture for OA of the target knee since parent trial enrollment year.
- Subjects who have had implanted electrical devices since parent trial enrollment (cardiac pacemakers, deep brain stimulators, implantable cardiac defibrillators).
- Subjects with a current new malignancy or who have received treatment for malignancy since parent trial enrollment, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
- Subjects with a new skin breakdown or infection in the area where the study device will be placed (quadriceps of the target knee).
- Subjects with any newly reported chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) or that have not been well-controlled during the parent trial.
- Subjects who have any new litigation for worker's compensation.
- Subjects with any new condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
- Subjects who are pregnant.
- Subject who enrolled in any new clinical study from the last day of treatment in the parent trial that required the use of an investigational device, drug or biologic.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04367597
Start Date
April 20 2020
End Date
March 16 2021
Last Update
March 18 2021
Active Locations (5)
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1
Noble Clinical Research
Tucson, Arizona, United States, 85704
2
Tucson Orthopedic Institute
Tucson, Arizona, United States, 85712
3
Synergy Group US LLC
Houston, Texas, United States, 77061
4
Synergy Group US LLC
Katy, Texas, United States, 77450