Condition category
Nervous System Diseases
Date applied
23/11/2019
Date assigned
04/07/2020
Last edited
03/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Cubital Tunnel Syndrome is a condition that involves pressure or stretching of the ulnar nerve (also known as the “funny bone” nerve), which can cause numbness or tingling in the ring and small fingers, pain in the forearm, and/or weakness in the hand. Surgery may be needed to relieve the pressure on the nerve. This can involve releasing the nerve, moving the nerve to the front of the elbow, and/or removing a part of the bone.
Supercharged end-to-side nerve transfer for severe cubital tunnel syndrome is a recently developed technique which involves attachment of an additional nerve to the damaged nerve in order to speed up recovery of the damaged nerve.

Who can participate?
Patients aged 18 years or above with severe cubital tunnel syndrome.

What does the study involve?
Participants will be randomly allocated to receive standard treatment or standard treatment with additional nerve attachment (supercharged end-to-side nerve transfer). Patients will be followed up for two years.

What are the possible benefits and risks of participating?
Benefits: Each participant was given a free electromyographic examination
Risks: The experimental group had one more incision

Where is the study run from?
Third Hospital of Hebei Medical University, China

When is the study starting and how long is it expected to run for?
January 2013 to October 2017

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Qing Xie
qxie710@sina.com

Trial website

Contact information

Type

Public

Primary contact

Ms Qing Xie

ORCID ID

Contact details

Third Hospital of Hebei Medical University
Shijiazhuang
050051
China
+86-13273148710
qxie710@sina.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

THHMU20130178

Study information

Scientific title

Conventional ulnar nerve decompression and transposition adding supercharged end-to-side pronator quadratus motor branch to motor branch of ulnar nerve transfer vs conventional ulnar nerve decompression and transposition alone for the treatment of advanced cubital tunnel syndrome: a comparison study

Acronym

SEPQMBMBUNT

Study hypothesis

The hypothesis is that the efficiency of ulnar nerve decompression and transposition is improved by adding the supercharged end-to-side pronator quadratus motor branch to motor branch of ulnar nerve transfer (SEPQMBMBUNT) in patients with advanced cubital tunnel syndrome.

Ethics approval

Approved 01/02/2013, Institutional Review Board of the Third Hospital of Hebei Medical University (Ziqiang Road, Shijiazhuang, Hebei, 050051, China; +86 (0)31188603632; no email provided), ref: 20190391

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced cubital tunnel syndrome

Intervention

Patients will be blinded and randomly allocated to the study group and control group. Patients in the study group will undergo the conventional ulnar nerve decompression and transposition adding supercharged end-to-side pronator quadratus motor branch to motor branch of ulnar nerve transfer. Patients in the control group will undergo conventional ulnar nerve decompression and transposition alone. Final assessments include pinch strength, 2-point discrimination of the little finger, and Disabilities of the Arm, Shoulder, and Hand Questionnaire.

Patients remained in hospital for 2 weeks and were followed up for 24 months.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Grip strength using a Jamar dynamometer (Sammons Preston Rolyan, Bolingbrook, Illinois), key pinch strength using a pinch gauge (B&L Engineering, Santa Ana, California), and tripod pinch strength (Baseline Hydraulic Pinch Meter, Fabrication Enterprises Inc., Irvington, NY, USA) at baseline and two years

Secondary outcome measures

1. 2-point discrimination of the little finger measured using Disk-Criminator (MackinnonDellon Partnership, Baltimore, MD) at baseline and two years
2. Disabilities of the Arm, Shoulder, and Hand measured using Gabel/Amadio score and disabilities of the arm, shoulder, and hand (DASH) questionnaire at baseline and two years

Overall trial start date

01/01/2013

Overall trial end date

11/10/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Severe cubital tunnel syndrome (Akahori’s Classification grade III, IV, and V)
3. A history of cubital tunnel syndrome >6 months
4. Unilateral limb involvement
5. Atrophy of intrinsic hand muscles innervated by the ulnar nerve, which was defined as a sign of advanced disease, no matter manifestation of grip weakness
6. A conduction velocity of 40 m/s or greater
7. No improvement or worse symptoms in mild disease after 3 months of nonsurgical treatments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Total final enrolment

90

Participant exclusion criteria

1. An additional lesion, such as cervical neuropathy
2. Thoracic outlet syndrome, or Guyon’s canal syndrome
3. Deformity or distortion of the cubital tunnel
4. Associated medical conditions capable of causing a non-compressive neuropathy, such as diabetes mellitus and rheumatism
5. Revision surgery for cubital tunnel syndrome

Recruitment start date

20/01/2013

Recruitment end date

20/10/2016

Locations

Countries of recruitment

China

Trial participating centre

Third Hospital of Hebei Medical University
Ziqiang Road Hebei
Shijiazhuang
050051
China

Sponsor information

Organisation

Third Hospital of Hebei Medical University

Sponsor details

Ziqiang Road
Shijiazhuang
050051
China
+86-13273148710
Zhikongban3610@163.com

Sponsor type

Hospital/treatment centre

Website

http://www.cthhmu.com/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/07/2020: Trial’s existence confirmed by Institutional Review Board of the Third Hospital of Hebei Medical University.