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Neuromuscular electrical stimulation for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by University of Vermont

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline cross-sectional area at 5 weeks

Awards & highlights

Study Summary

This trial tests a new device that may help to reduce the negative effects of a total knee replacement on lower extremity muscle.

Eligible Conditions

Osteoarthritis of the Knee

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline cross-sectional area at 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline cross-sectional area at 5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline cross-sectional area at 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cross-sectional area of muscle fibers

Intermyofibrillar mitochondrial content

Maximal calcium-activated tension single muscle fiber tension and shortening velocity

+1 more

Secondary outcome measures

Physical activity level

Physical functional measures

Quadriceps muscle cross-sectional area

+1 more

Side effects data

From 2019 Phase 1 & 2 trial • 25 Patients • NCT02945553

Re-injury of ACL (graft failure)

Re-injury of meniscus

100%

80%

60%

40%

20%

Study treatment Arm

Microstimulation

Neuromuscular Electrical Stimlulation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NMESExperimental Treatment1 Intervention

Neuromuscular electrical stimulation (NMES) will be administered for 5 weeks post-TKA in the quadriceps of the surgical leg. Treatment will occur 5 days per week, twice daily for 45 minutes on each occasion.

Group II: ControlActive Control1 Intervention

No intervention will be administered during the 5 weeks post-TKA in the surgical leg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neuromuscular electrical stimulation

2014

Completed Phase 2

~850

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Who is running the clinical trial?

University of VermontLead Sponsor

266 Previous Clinical Trials

3,743,668 Total Patients Enrolled

2 Trials studying Osteoarthritis

95 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment seek participants aged 20 and above?

"This research is only considering individuals aged over 50 and below 75."

Answered by AI

How many participants are engaged in the current clinical experiment?

"Correct. According to clinicaltrials.gov, this research venture commenced on the 1st of January in 2017 and was recently updated on October 31st 2022. Currently, 48 individuals are needed across a single trial site."

Answered by AI

What does the team hope to accomplish through this experiment?

"This study will assess Cross-sectional area of muscle fibers over a 5 week timeframe as its primary outcome. Secondary outcomes include Whole muscle strength (measured with dynamometry), Physical functional measures, and Quadriceps Muscle cross-sectional area (evaluated by computed tomography)."

Answered by AI

What are the eligibility criteria to partake in this trial?

"This clinical experiment is seeking 48 individuals aged between 50 and 75, who suffer from symptomatic primary knee osteoarthritis. Furthermore, these participants must be under consideration for total knee arthroplasty."

Answered by AI

Are there any vacancies for participants in this experiment?

"Affirmative. Evidence on clinicaltrials.gov attests that this experiment is currently seeking subjects. It was initially posted on January 1st 2017 and the information has been updated most recently in October 31st 2022, with a total of 48 patients being sought at one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Skeletal Muscle Atrophy and Dysfunction Following Total Knee Arthroplasty

Michael J. Toth, Ph.D. 2017. "Skeletal Muscle Atrophy and Dysfunction Following Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03051984.