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Trial record 1 of 1 for:    "Ulnar Neuropathy" | "Immunologic Factors"
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Perineural Injection Therapy for Ulnar Neuropathy at Elbow

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ClinicalTrials.gov Identifier: NCT02986906
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, 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.

Condition or disease Intervention/treatment Phase
Ulnar Neuropathy at Elbow Drug: 5% dextrose Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg) Device: Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5% dextrose
The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy
Drug: 5% dextrose
Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve

Device: Ultrasound
The ultrasound was used for injection guidance

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

Device: Ultrasound
The ultrasound was used for injection guidance




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  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.

  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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986906


Contacts
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Contact: Yung-Tsan Wu, MD 886-2-87923311 ext 17068 crwu98@gmail.com

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Not yet recruiting
Taipei, Neihu District, Taiwan, 886
Contact: Yung-Tsan Wu, MD    886-2-8792-3311 ext 17068    crwu98@gmail.com   
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Recruiting
Taipei, Neihu District, Taiwan, 886
Contact: Yung-Tsan Wu, MD    886-2-8792-3311 ext 17068    crwu98@gmail.com   
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications of Results:
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Responsible Party: Yung-Tsan Wu, Attending Physician of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02986906     History of Changes
Other Study ID Numbers: PIT for ulnar neuropathy
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
ulnar neuropathy at elbow
Dextrose
perineural injection
Additional relevant MeSH terms:
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Ulnar Neuropathies
Immunologic Factors
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Mononeuropathies
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action