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
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