Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Study Overview
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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.

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.

Official Title
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The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Conditions
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Ulnar Neuropathy at Elbow

Intervention / Treatment
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* Drug: 5% dextrose
* Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
* Device: Ultrasound


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5% dextrose<br>The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy | Drug: 5% dextrose<br>* Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve<br>Device: Ultrasound<br>* The ultrasound was used for injection guidance<br>|
| Active Comparator: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)<br>The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg) | Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)<br>* Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve<br>Device: Ultrasound<br>* The ultrasound was used for injection guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pain on 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. | Pre-treatment, 1st, 3rd, 6th month after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from severity of symptoms and functional status on 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. | Pre-treatment, 1st, 3rd, 6th month after injection | 
| Change from nerve conduction velocity on 1st, 3rd, 6th month after injection | Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment. | Pre-treatment, 1st, 3rd, 6th month after injection | 
| Change from cross-sectional area on 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. | Pre-treatment, 1st, 3rd, 6th month after injection | 
| Change from palmer finger pinch and grasp on 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. | Pre-treatment, 1st, 3rd, 6th month after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulnar neuropathy at elbow, Dextrose, perineural injection