Clinical Trial: Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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 2% Xylocaine+3cc Triamcinolone (30mg) (total 5 cc) ultrasound-guided PIT injection. The primary outcome is visual analog scale (VAS) and secondary outcomes include Disabilities of the Arm, Shoulder and Hand (DASH), 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.
Sponsor: Tri-Service General Hospital

Current Primary Outcome: Change from pain on 1st, 3rd, 6th month after injection [ Time Frame: Pre-treatment, 1st, 3rd, 6th month after injection ]

Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    Using the Taiwan Disabilities of the Arm, Shoulder and Hand, DASH to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Tri-Service General Hospital

Dates:
Date Received: December 6, 2016
Date Started: March 1, 2017
Date Completion: May 31, 2018
Last Updated: March 1, 2017
Last Verified: March 2017