Ignite Creation Date:
2024-05-06 @ 7:34 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02566616
Status:
WITHDRAWN
Last Update Posted:
2017-04-05
First Post:
2015-09-30
Brief Title:
Electrical Nerve Stimulation of the Ulnar Nerve
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery Does it Improve Long Term Functional Outcomes
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTIM
Brief Summary:
Cubital tunnel syndrome is caused by compression of the ulnar nerve at the elbow This leads to symptoms such as chronic hand weakness numbness and pain This is usually treated with a surgical procedure where the nerve is decompressed Research has shown that nerve simulators speed up the recovery of nerves following injury The purpose of our research is to examine the difference in patient outcomes after the nerve decompression surgery with and without nerve stimulation
Our research questions is What are the differences in long term functional outcomes of patients that have ulnar nerve decompression surgery with and without nerve stimulation
Our research questions is What are the differences in long term functional outcomes of patients that have ulnar nerve decompression surgery with and without nerve stimulation
Detailed Description:
1 Patients will be seen in University of Chicago clinics if they are diagnosed with Cubital Tunnel Syndrome they will be approached to be enrolled in our study
2 If they fit inclusion and exclusion criteria failed conservative management and consent to be part of the study they will be scheduled for Cubital Tunnel Surgery and randomized into interventionnon-intervention group
3 Patients will have pre-operative subjective pain and upper extremity function surveys and objective hand strengthsensation measurements done by a blinded Occupational Therapist in University of Chicago Occupational Therapy Clinic Patient will also have a pre-operative EMG done
4 Patient will be discharged following surgery and followed up at 6 weeks 3 months 6 months 12 months EMG will be done at 3 months and the same outcome measurements Pain scores PRUNE evaluation QuickDash Questionnaire Michigan hand Questionnaire grip strength sensation measurements will be taken at each postoperative visit by the same blinded occupational therapist
5 Data will be compared pre and postoperatively
2 If they fit inclusion and exclusion criteria failed conservative management and consent to be part of the study they will be scheduled for Cubital Tunnel Surgery and randomized into interventionnon-intervention group
3 Patients will have pre-operative subjective pain and upper extremity function surveys and objective hand strengthsensation measurements done by a blinded Occupational Therapist in University of Chicago Occupational Therapy Clinic Patient will also have a pre-operative EMG done
4 Patient will be discharged following surgery and followed up at 6 weeks 3 months 6 months 12 months EMG will be done at 3 months and the same outcome measurements Pain scores PRUNE evaluation QuickDash Questionnaire Michigan hand Questionnaire grip strength sensation measurements will be taken at each postoperative visit by the same blinded occupational therapist
5 Data will be compared pre and postoperatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None