Cubital Tunnel SyndromeESTIMNCT02566616
Electrical Nerve Stimulation of the Ulnar Nerve
A study testing Ulnar Nerve Stimulation in people with Cubital Tunnel Syndrome, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- Ulnar Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 1 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- EMG confirmed ulnar nerve neuropathy at cubital tunnel with or without these symptoms:
- Paresthesia or numbness of the small finger and/or ring finger
- Complaints of hand weakness
- Exam shows positive flexion compression test at elbow and/or positive tinel's sign at the cubital tunnel
- Failed conservative management for 6 weeks
- ○ Has completed a combination of these for 6 weeks and still has symptoms
Show all 11Show fewer
- Night splinting in 45-60 degrees of flexion and forearm neutral
- Padding of elbow with an elbow pad during the day
- Daily NSAIDs if able to take them
- Cubital tunnel steroid injection
- Age restriction: 18--65years old
Who cannot join
- Psychiatric conditions
- Workman's compensation patients
- Neurologic conditions (ex. MS)
- Inflammatory rheumatologic conditions (Connective tissues disease, RA… etc)
- Associated elbow and upper extremity fractures
- Previous Cubital Tunnel Surgeries
- Previous C-Spine Surgeries
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?
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?
Read the detailed description
- 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
- 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 intervention/non-intervention group
- Patients will have pre-operative subjective pain and upper extremity function surveys and objective hand strength/sensation measurements done by a blinded Occupational Therapist in University of Chicago Occupational Therapy Clinic. Patient will also have a pre-operative EMG done.
- 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
- Data will be compared pre and postoperatively
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- Ulnar Nerve Stimulation
- Medical subject headings
- Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulnar Nerve StimulationDevice
Also called Stimulation
1 hour of continued stimulation of the ulnar nerve using a hand held stimulator
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cubital Tunnel Release with stimulator for nerve location
1 hour of Ulnar nerve stimulation Receives: Device: Ulnar Nerve Stimulation |
| Non-Intervention | Active comparator | Cubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation Receives: Device: Ulnar Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Related Ulnar Nerve Evaluation
PRUNE Survey with 0-100 score
Measured: 10 minutes
Secondary outcomes (2)
QuickDASH
Survey
Measured: 10 minutes, pre op and each post op visit
Michigan Hand Questionnaire
Survey
Measured: 20 minutes, pre op and each post op visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jovito Angeles, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566616
- Sponsor's protocol ID
- 14-0646
- Acronym
- ESTIM
- Status last verified
- Apr 2017
- First submitted
- 30 Sep 2015
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes?
- ClinicalTrials.gov ID
- NCT02566616
- Acronym / sponsor ID
- ESTIM / 14-0646
- Conditions
- Cubital Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
- 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
- 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 intervention/non-intervention group
- Patients will have pre-operative subjective pain and upper extremity function surveys and objective hand strength/sensation measurements done by a blinded Occupational Therapist in University of Chicago Occupational Therapy Clinic. Patient will also have a pre-operative EMG done.
- 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
- Data will be compared pre and postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Ulnar Nerve StimulationCubital Tunnel Release with stimulator for nerve location 1 hour of Ulnar nerve stimulation |
| Non-Intervention | Active comparator | Device: Ulnar Nerve StimulationCubital Tunnel Release with stimulator for nerve location NO prolonged ulnar nerve stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- EMG confirmed ulnar nerve neuropathy at cubital tunnel with or without these symptoms:
- Failed conservative management for 6 weeks
- ○ Has completed a combination of these for 6 weeks and still has symptoms
- Age restriction: 18--65years old
Key exclusion criteria (8 listed)
- Psychiatric conditions
- Workman's compensation patients
- Neurologic conditions (ex. MS)
- Inflammatory rheumatologic conditions (Connective tissues disease, RA… etc)
- Associated elbow and upper extremity fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulnar Nerve StimulationAlso: Stimulation1 hour of continued stimulation of the ulnar nerve using a hand held stimulator | Device | Intervention, Non-Intervention |
Primary outcome
Patient Related Ulnar Nerve Evaluation
Time frame: 10 minutes
PRUNE Survey with 0-100 score
2 secondary outcomes
QuickDASH
Time frame: 10 minutes, pre op and each post op visit
Michigan Hand Questionnaire
Time frame: 20 minutes, pre op and each post op visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jovito Angeles, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulnar Nerve Stimulation in people with Cubital Tunnel Syndrome, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Related Ulnar Nerve Evaluation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.