Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Not Applicable

Completed

• Conditions: Ulnar Neuropathy at Elbow
• Interventions: Drug: 5% dextrose; Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg); Device: Ultrasound

• Registration Number: NCT02986906
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-08
• Study Start: 2017-03-01
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% dextrose	5% dextrose	The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy
5% dextrose	Ultrasound	The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy
2cc 0.9% normal saline+3cc Triamcinolone (30mg)	2cc 0.9% normal saline+3cc Triamcinolone (30mg)	The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
2cc 0.9% normal saline+3cc Triamcinolone (30mg)	Ultrasound	The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)

Primary Outcome Measures

Name	Time	Method
Change from pain on 1st, 3rd, 6th month after injection	Pre-treatment, 1st, 3rd, 6th month after injection	Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.

Secondary Outcome Measures

Name	Time	Method
Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection	Pre-treatment, 1st, 3rd, 6th month after injection	Taiwan Disabilities of the Arm, Shoulder and Hand (DASH) contains 11-item disability/symptom scale and each item has five levels of response scoring from 1 to 5. The higher score means more disability or severer symptoms.
Change from nerve conduction velocity on 1st, 3rd, 6th month after injection	Pre-treatment, 1st, 3rd, 6th month after injection	Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Change from cross-sectional area on 1st, 3rd, 6th month after injection	Pre-treatment, 1st, 3rd, 6th month after injection	Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.
Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection	Pre-treatment, 1st, 3rd, 6th month after injection	The palmer finger pinch and grasp strength was measured using dynamometer (Fabrication Enterprises Inc., USA) before treatment and multiple time frame after treatment.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan