Clinical trial NCT03737916: The Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow
Official title: To Evaluate the Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow and to Compare the Control Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulnar Neuropathies
Lead sponsor: Ankara Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline of pain on 2nd week, 1st and 3rd months after treatment: VAS
timeFrame: Time Frame: Pre-treatment, 2nd week, 1st and 3rd months after treatment
Secondary outcomes:
measure: Change from baseline in activity and functional status on 2nd week, 1st and 3rd months after treatment.
timeFrame: Pre-treatment, 2nd week, 1st and 3rd months after treatment
measure: Change from baseline in cross-sectional area of the ulnar nerve on 1st and 3th months after treatment.
timeFrame: Pre-treatment, 2nd week, 1st and 3rd months after treatment treatment
measure: Change from baseline in motor nerve conduction velocity of the ulnar nerve
timeFrame: Pre-treatment, 1st and 3rd months after treatment treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Basak Mansiz-Kaplan
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation
name: Basak Mansiz-Kaplan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: