The Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow

Study Overview
=================
Brief Summary
-----------------
Ulnar neuropathy at the elbow (UNE) is the second most common neuropathy and occurs after recurrent or elongated elbow flexion. Diagnosis of UNE depends on clinical symptoms, physical examination, and electrophysiological findings. Imaging methods such as ultrasonography (USG) and magnetic resonance imaging show cross-sectional area and echogenicity of ulnar nerve and give information about to surrounding structures around the ulnar nerve. In mild and moderate cases, conservative treatments are administered up to 6 months, who do not benefit from conservative treatment are referred to surgery. There are not many options for conservative treatment. Activity modification, nerve gliding exercises and night splints are conservative treatment methods. Steroid injection is no longer recommended. Perineural dextrose injection is applied in tendinopathies and entrapment neuropathies (especially carpal tunnel syndrome). In the literature, there is no study showing effect of perineural dextrose injection in patients with UNE. The investigators design a randomized, double-blind, controlled trail to evaluate the effect after ultrasound-guided perineural injection with 5% dextrose in patients with UNE.

Detailed Description
-----------------
After obtaining written informed consent, patients of clinically diagnosed with UNE were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Quick-DASH (Disabilities of Arm, Shoulder and Hand), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity and distal latency of the ulnar nerve. The evaluation was performed pretreatment as well as on the 2nd week, 1st and 3rd month after the treatment.

Official Title
-----------------
To Evaluate the Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow and to Compare the Control Group

Conditions
-----------------
Ulnar Neuropathies

Intervention / Treatment
-----------------
* Other: 5 cc 5% Dextrose solution
* Other: 5 cc salin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-65 year-old. Neuropathic pain on the ulnar nerve distribution area for at least 1 months Diagnosis was confirmed using an electrophysiological studies and ultrasonography Exclusion Criteria: History of trauma to the upper extremity Central or peripheral neurologic disease Electromyography (EMG)-proven carpal tunnel syndrome, radiculopathy or any other neuropathy Pregnancy or any systemic disease that might cause swelling on nerves (e.g., diabetes -mellitus, renal failure, and thyroid disease) USG-detected bifid or trifid median nerve, persistent median artery, or space-occupying lesions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dextrose group<br>Procedure: Ultrasound-guided perineural injection with 5% dextrose. Ultrasound-guided perineural injection with 5% Dextrose (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc). Drug: 5% Dextrose 5% Dextrose could decrease the release of CGRP (Calcitonin Gene Related Peptide) and substance P to reduce the nerve inflammation | Other: 5 cc 5% Dextrose solution<br>* Ultrasound-guided perineural injection with 5% Dextrose (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).<br>|
| Placebo Comparator: control group<br>Procedure: Perineural injection with normal saline Ultrasound-guided perineural injection with normal saline (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc). Drug: Normal Saline Normal saline is safe for perineural injection. | Other: 5 cc salin<br>* Ultrasound-guided perineural injection with salin (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of pain on 2nd week, 1st and 3rd months after treatment: VAS | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain. | Time Frame: Pre-treatment, 2nd week, 1st and 3rd months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in activity and functional status on 2nd week, 1st and 3rd months after treatment. | Using the Quick-DASH to measure the activity and functional status before treatment and multiple time frame after treatment. The Quick-DASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The higher scores indicate worse functional status. | Pre-treatment, 2nd week, 1st and 3rd months after treatment | 
| Change from baseline in cross-sectional area of the ulnar nerve on 1st and 3th months after treatment. | Using the musculoskeletal ultrasonography to measure the cross-sectional area of the ulnar nerve. | Pre-treatment, 2nd week, 1st and 3rd months after treatment treatment | 
| Change from baseline in motor nerve conduction velocity of the ulnar nerve | Using Electromyography to measure the motor nerve conduction velocity (m/sn) of the ulnar nerve | Pre-treatment, 1st and 3rd months after treatment treatment |