Perineural Injection Therapy for Ulnar Neuropathy at 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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulnar Neuropathy at Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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5% dextrose

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

Group Type EXPERIMENTAL

5% dextrose

Intervention Type DRUG

Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve

Ultrasound

Intervention Type DEVICE

The ultrasound was used for injection guidance

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve

Ultrasound

Intervention Type DEVICE

The ultrasound was used for injection guidance

Interventions

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5% dextrose

Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve

Intervention Type DRUG

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

Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve

Intervention Type DRUG

Ultrasound

The ultrasound was used for injection guidance

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes