Tolerability and patient feedback study of a novel ulnar nerve splint
Research type
Research Study
Full title
Tolerability and patient feedback study of a novel ulnar nerve splint
IRAS ID
196843
Contact name
Andrew Michell
Contact email
Sponsor organisation
CUH NHS Foundation Trust
Clinicaltrials.gov Identifier
, http://www.researchregistry.com/browse-the-registry.html#home/registrationdetails/575fe3f0ba3603752b977bde/; ,
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
Tingling or numbness of the fingers is a common symptom, often caused by ulnar nerve entrapment at the elbow when that tingling affects the little and ring fingers. Currently, for first line treatment, patients are generally advised to avoid direct pressure on the nerve at the elbow, and reduce prolonged elbow flexion. There is currently no splint available to accomplish both these goals, thus we have designed one.
The aim of this pilot study is to gather safety data and preliminary patient feedback about comfort and tolerability of the splint we have designed. Provided the splint is well tolerated we then plan a further trial to look at how effective it is at reducing symptoms and allowing the nerve to heal (not part of the current application).
We plan to study upto 15 adult subjects with symptoms of ulnar nerve entrapment. All will have nerve conduction studies, as requested by their referring clinicians, and, if they consent, will be fitted with an appropriate splint. They will be asked to return in upto 8 weeks for re-assessment and to feed back on their experiences and symptoms.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0162
Date of REC Opinion
24 May 2016
REC opinion
Further Information Favourable Opinion