Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Tri-Service General Hospital

Status: Completed

Conditions: Ulnar Neuropathy at Elbow

Treatments: Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg); Device: Ultrasound; Drug: 5% dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT02986906

PIT for ulnar neuropathy

Details and patient eligibility

About

Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy. Although many conservative managements of UNE, the effectiveness of these methods are unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment for entrapment neuropathy. However, current studies have not proved the effects of PIT on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. We design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.

Full description

After obtaining written informed consent, 40 patients, clinically diagnosed with mild or moderate UNE were randomized into intervention or control group. Participants in intervention group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc) ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the 1st, 3rd and 6th month after the treatment.

Enrollment: 36 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 20-80 year-old.
• Diagnosis was confirmed using an electrophysiological study

Exclusion criteria

• Cancer
• Coagulopathy
• Pregnancy
• Inflammation status
• Cervical radiculopathy
• Polyneuropathy, brachial plexopathy
• Thoracic outlet syndrome
• Previously undergone wrist surgery or steroid injection for ulnar neuropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

5% dextrose

Experimental group

Description:

The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy

Treatment:

Device: Ultrasound

Drug: 5% dextrose

2cc 0.9% normal saline+3cc Triamcinolone (30mg)

Active Comparator group

Description:

The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)

Treatment:

Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)

Device: Ultrasound