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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-18

Study Completion Date

2020-11-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Perineural Injection Therapy for Ulnar Neuropathy at Elbow

NCT02986906

Ulnar Neuropathy at Elbow

COMPLETED NA

Efficacy of Shortwave Diathermy in Ulnar Nerve Entrapment on the Elbow

NCT04275505

Ulnar Nerve Entrapment at Elbow

COMPLETED NA

Efficacy of Ultrasound-Guided PRP Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow

NCT05567081

Ulnar Neuropathy at Elbow

COMPLETED PHASE2/PHASE3

Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

NCT04264000

Ulnar Neuropathy at Elbow

COMPLETED NA

Ultrasonographic Insulin Versus Dexamethasone Injection With Local Anestheticss in Diabetic Patients With Mild to Moderate Median Nerve Entrapement Neuropathy .

NCT04781751

Pain, Neuropathic

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulnar Neuropathies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dextrose group

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

Group Type EXPERIMENTAL

5 cc 5% Dextrose solution

Intervention Type 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).

control group

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.

Group Type PLACEBO_COMPARATOR

5 cc salin

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

5 cc 5% Dextrose solution

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).

Intervention Type OTHER

5 cc salin

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No