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

NCT03737916 | Completed

• 1 other identifier: E171616
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulnar Neuropathies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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.

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

• Change from baseline in motor nerve conduction velocity of the ulnar nerve

  Pre-treatment, 1st and 3rd months after treatment treatment

Study Arms (2)

dextrose group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

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).

dextrose group

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).

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Education and Research Hospital: lead

Study Sites (1)

Basak Mansiz-Kaplan

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• Mansiz-Kaplan B, Nacir B, Pervane-Vural S, Tosun-Meric O, Duyur-Cakit B, Genc H. Effect of Perineural Dextrose Injection on Ulnar Neuropathy at the Elbow: A Randomized, Controlled, Double-Blind Study. Arch Phys Med Rehabil. 2022 Nov;103(11):2085-2091. doi: 10.1016/j.apmr.2022.04.013. Epub 2022 Jun 9.

  PMID: 35690093 DERIVED

MeSH Terms

Conditions

Ulnar Neuropathies

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Basak Mansiz-Kaplan, M.D.

  Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physical Medicine and Rehabilitation (the principal investigator)

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 13, 2018
• Study Start: November 18, 2018
• Primary Completion: June 18, 2020
• Study Completion: November 18, 2020
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

TU (1)