Comparative evaluation of the therapeutic results of two methods of ulnar nerve decompression with transposition and ulnar nerve decompression alone in patients with cubital tunnel syndrome
Comparison of two methods "ulnar nerve decompression with transposition" and "ulnar nerve decompression alone" on improving patients with cubital tunnel syndrome
Design
A randomized single-blinding clinical trial, with the parallel groups
Settings and conduct
In this study, 50 patients with cubital tunnel syndrome will be included in the study and will be randomly divided into two groups. In one group, decompression surgery will be performed alone and in the other group, decompression and transposition surgery will be performed. Then patients' symptoms improve will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria included the diagnosis of cubital syndrome by electromyography and nerve conduction velocity (EMG-NCV), non-response to non-surgical treatments performed so far, and Satisfaction to participate in the study. Exclusion criteria are history of hand surgery, history of trauma penetrating the nerves of the hand, and history of cervical neurosurgery.
Intervention groups
Intervention group 1: Patients in this group will undergo decompression and transposition surgery. Intervention group 2: Patients in this group undergo only decompression surgery.
Main outcome variables
Patient's symptom recovery score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N17
Registration date:2020-12-24, 1399/10/04
Registration timing:registered_while_recruiting
Last update:2020-12-24, 1399/10/04
Update count:0
Registration date
2020-12-24, 1399/10/04
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-07, 1399/09/17
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the therapeutic results of two methods of ulnar nerve decompression with transposition and ulnar nerve decompression alone in patients with cubital tunnel syndrome
Public title
Comparison of two methods "ulnar nerve decompression with transposition" and "ulnar nerve decompression alone" in improving patients with cubital tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of cubital syndrome by electromyography and nerve conduction velocity(EMG-NCV)
Failure to respond to non-surgical treatments performed so far
Satisfaction to participate in the study
Exclusion criteria:
History of hand surgery
History of trauma penetrating the nerves of the hand
History of cervical neurosurgery
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the different use of the two surgical methods, the orthopedic assistant is aware of the type of intervention. But the patient, data collector, and data analyst will not know of the type of patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-12-05, 1399/09/15
Ethics committee reference number
IR.MUI.MED.REC.1399.800
Health conditions studied
1
Description of health condition studied
Cubital Tunnel Syndrome
ICD-10 code
G56.20
ICD-10 code description
Lesion of ulnar nerve, unspecified upper limb
Primary outcomes
1
Description
Symptom improvement score
Timepoint
One month, three months, six months and one year after the intervention
Method of measurement
Modified Bishop rating system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, the patient is located in a supine position, and after closing the tourniquet or Esmarch bandage, and prepping and draping the upper part of the limb. 15 cm skin cutting begins from about 5-6 cm from distal to the posterior medial epicondyle and continues to 10 cm from proximal to the medial epicondyle. After cutting the skin and opening the skin and subcutaneous tissue and protecting the antebrachial cutaneous nerve, the ulnar nerve is explored (posterior to medial intermuscular septum and anterior to the interior head of the triceps). Pressure points on the nerve are released along this path, the arcade of the structure is removed, and the ulnar nerve feeding vessels are retained as long as possible. The ulnar nerve is released and after examination for the absence of pathological lesions and adhesion of the wound, it is washed and repaired skin and under the skin and the dressing and bandage are done by bandaging from the palm crease to the top of the arm.
Category
Treatment - Surgery
2
Description
Intervention group 2: In this group, the patient is located in a supine position and after closing the tourniquet or Esmarch bandage, and prepping and draping the upper part of the limb. 15 cm skin cutting begins from about 5-6 cm from distal to the posterior medial epicondyle and continues to 10 cm from proximal to the medial epicondyle. After cutting the skin and opening the skin and subcutaneous tissue and protecting the antebrachial cutaneous nerve, the ulnar nerve is explored (posterior to medial intermuscular septum and anterior to the interior head of the triceps). Pressure points on the nerve are released along this path, the arcade of struther is removed, and the ulnar nerve feeding vessels are retained as long as possible. The ulnar nerve is released and after examination for the absence of pathological lesions and adhesion of the wound, it is washed and repaired skin and under the skin and the dressing and bandage is done by bandaging from the palm crease to the top of the arm.The ulnar nerve after the release of the abovementioned path, the entrance to the forearm by keeping the branches of the nerve to the flexor carpi ulnaris muscle and no damage to them is passed to the anterior flexor-pronator mass and under a tab of flexor and pronator group fascia, which is about 1.5 inches long and 1.5 inches wide, is placed and the tab base is in the medial direction and its lateral edge is exposed to the subcutaneous tissue. After transposition and opening of the tourniquet, homeostasis is performed well. The hemovac drain is placed, the skin and under the skin are sewn, and the dressing and bandage are applied with a bandage from the palm crease to the top of the arm.