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Welcome to UNDER study

  • "Ulnar Nerve" by BruceBlaus is licensed under CC BY 4.00
    A medical illustration depicting the ulnar nerve
    Ulnar Nerve
  • UNDER Study
    UNDER Study Logo
    UNDER Study

Cubital Tunnel syndrome (also known as CuTS, and Ulnar Nerve Compression) is a common type of nerve problem in the arm resulting in pins and needles, pain and /or weakness in the hand. It happens when the ulnar nerve, one of the three main nerves in your arm become squashed (compressed) or irritated. The condition affects approximately 6% of the population. For those whose symptoms are not managed, doctors can offer surgery. This surgery is called ulnar nerve decompression surgery.

There are currently two ways of performing ulnar nerve decompression in the UK, they are called open decompression surgery and endoscopic decompression surgery. 

Both surgical techniques have potential advantages and disadvantages and the UNDER study is investigating which is better both in the short and longer term for patients with CuTS, and the results of this study will provide definitive evidence to guide future decision making for patients and clinicians in the treatment of CuTS.

This study will consist of two phases. The first to assess the training of experienced decompression surgeons in the endoscopic technique and how well patients recover post-surgery as, although both techniques are performed within the NHS and the surgeon has been trained in performing both techniques, endoscopic decompression is less widely used. The second phase will be a randomised control trial where the two techniques will be compared.

Information for Patients
Questionnaire

Image (c) iStock

Patients will be recruited from NHS hospitals across the UK. If you are suffering from CuTS and are suitable for surgery, you may be invited to join the UNDER Study by either your treating surgeon or a member of the local research team. If you decide to take part, you will complete up to 3 questionnaires for up to 24-months and a clinic visit 3 months after your surgery

Information for Researchers
Surgeons training

Image (c) Chris McGhee

UNDER study is a REC and HRA approved non-CTIMP Clinical Trial and is part of the NIHR portfolio.

Surgeons who take part in UNDER Study will receive training in the Endoscopic Decompression technique at a half-day training workshop.

UNDER Study is registered with the Associate PI scheme.

UNDER study is still open to new sites, so if you or your colleagues are interested, please contact us: understudy@ndorms.ox.ac.uk

Latest news
News icon

UNDER Study received approval for a Protocol amendment on 26Nov2024.

UNDER Study Opened to Recruitment on 11th April 2024. Queen Elizabeth Hospital, Birmingham is the first recruiting hospital.

UNDER Study was added to ISRCTN registry on 29th February 2024.

UNDER Study received REC and HRA approval on 29th January 2024.

Quick Info

Recruitment Progress:

334
0

Date of latest recruit:

No date given

Site of latest recruit:

No site given
  • UNDER Study logo
  • SITU logo
  • OCTRU logo
  • University Hospitals Birmingham NHS Foundation Trust logo
  • HaPPeN logo
  • NIHR logo
  • NIHR Associate PI Badge
Regulatory Information

Funded by: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) ref: 135260

Sponsored by: University Hospital Birmingham NHS Foundation Trust

CTU: OCTRU - SITU

REC: West Midlands – Solihull - Research Ethic Committee ref: 24/WM/0002

IRAS: 324952

NIHR Portfolio: 60315

ISRCTN: ISRCTN65991101

Oversight Committees

Trial Steering Committee:

Mr Dale Vimalachandran (Chair)

Mr Alex Mitchell

Mr Adam Reid

Prof Tracey Sachs

Mr Anuj Mishra

Mrs Maureen Harper (PPI representative)

Data and Safety Monitoring Committee:

Prof Jane Blazeby

Assoc Prof Helen Parsons

Mr Tom Quick

Trial Management Team

Dominic Power (Chief Investigator)

David Beard

Abdus Burahee

Caroline Miller

Christopher McGhee

Sofia Massa

Stavros Petrou

Loretta Davies

Tomas Madura

Tahseen Chaudhry

Heidi Fletcher

Scott Parsons

Alex Zimmermann

Contact Information

Address:

UNDER Study

The Botnar Research Centre

Old Road

Headington

Oxford

OX3 7LD

Telephone: +44 (0) 1865 223489

Email: understudy@ndorms.ox.ac.uk

x/Twitter: @TheUNDERStudy

Bluesky: the-under-study.bsky.social