Comparing the effectiveness of two treatments for severe cubital tunnel syndrome

ISRCTN ISRCTN91919572
DOI https://doi.org/10.1186/ISRCTN91919572
Secondary identifying numbers THHMU20130178
Submission date
23/11/2019
Registration date
04/07/2020
Last edited
17/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Ms Qing Xie
Public

Third Hospital of Hebei Medical University
Shijiazhuang
050051
China

Phone +86-13273148710
Email qxie710@sina.com

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleConventional 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
Study acronymSEPQMBMBUNT
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedAdvanced cubital tunnel syndrome
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measureGrip 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 measures1. 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 study start date01/01/2013
Completion date11/10/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Total final enrolment90
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment20/01/2013
Date of final enrolment20/10/2016

Locations

Countries of recruitment

  • China

Study participating centre

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

Sponsor information

Third Hospital of Hebei Medical University
Hospital/treatment centre

Ziqiang Road
Shijiazhuang
050051
China

Phone +86-13273148710
Email Zhikongban3610@163.com
Website http://www.cthhmu.com/
ROR logo "ROR" https://ror.org/004eknx63

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/12/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 03/09/2021 17/03/2022 Yes No

Editorial Notes

17/03/2022: Publication reference added.
03/07/2020: Trial’s existence confirmed by Institutional Review Board of the Third Hospital of Hebei Medical University.