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NCT Number: NCT02986906

Perineural Injection Therapy for Ulnar Neuropathy at Elbow

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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Key information

Conditions

Ulnar Neuropathy at Elbow

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5% Dextrose

Drug

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

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

Drug

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

Ultrasound

Device

The ultrasound was used for injection guidance

Primary outcomes

  1. Change from pain on 1st, 3rd, 6th month after injection

    Time frame: 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 outcomes

  1. Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection

    Time frame: 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.

  2. Change from nerve conduction velocity on 1st, 3rd, 6th month after injection

    Time frame: Pre-treatment, 1st, 3rd, 6th month after injection

    Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.

  3. Change from cross-sectional area on 1st, 3rd, 6th month after injection

    Time frame: 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.

  4. Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2016
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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