Skip to main content
OpenTrials
Completed

NCT Number: NCT03737916

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulnar Neuropathies Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basak Mansiz-Kaplan

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5 cc 5% Dextrose solution

Other

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).

5 cc salin

Other

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).

Primary outcomes

  1. Change from baseline of pain on 2nd week, 1st and 3rd months after treatment: VAS

    Time frame: Time Frame: Pre-treatment, 2nd week, 1st and 3rd months after treatment

    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.

Secondary outcomes

  1. Change from baseline in activity and functional status on 2nd week, 1st and 3rd months after treatment.

    Time frame: Pre-treatment, 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.

  2. Change from baseline in cross-sectional area of the ulnar nerve on 1st and 3th months after treatment.

    Time frame: Pre-treatment, 2nd week, 1st and 3rd months after treatment treatment

    Using the musculoskeletal ultrasonography to measure the cross-sectional area of the ulnar nerve.

  3. Change from baseline in motor nerve conduction velocity of the ulnar nerve

    Time frame: Pre-treatment, 1st and 3rd months after treatment treatment

    Using Electromyography to measure the motor nerve conduction velocity (m/sn) of the ulnar nerve

Sponsors and collaborators

Lead sponsor

Ankara Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2018
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.