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Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Primary Purpose

Ulnar Neuropathy at Elbow

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
5% dextrose
2cc 0.9% normal saline+3cc Triamcinolone (30mg)
Ultrasound
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulnar Neuropathy at Elbow focused on measuring ulnar neuropathy at elbow, Dextrose, perineural injection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5% dextrose

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 6, 2016
Last Updated
November 19, 2019
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02986906
Brief Title
Perineural Injection Therapy for Ulnar Neuropathy at Elbow
Official Title
The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Neuropathy at Elbow
Keywords
ulnar neuropathy at elbow, Dextrose, perineural injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5% dextrose
Arm Type
Experimental
Arm Description
The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy
Arm Title
2cc 0.9% normal saline+3cc Triamcinolone (30mg)
Arm Type
Active Comparator
Arm Description
The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
Intervention Type
Drug
Intervention Name(s)
5% dextrose
Intervention Description
Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve
Intervention Type
Drug
Intervention Name(s)
2cc 0.9% normal saline+3cc Triamcinolone (30mg)
Intervention Description
Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
The ultrasound was used for injection guidance
Primary Outcome Measure Information:
Title
Change from pain on 1st, 3rd, 6th month after injection
Description
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.
Time Frame
Pre-treatment, 1st, 3rd, 6th month after injection
Secondary Outcome Measure Information:
Title
Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection
Description
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.
Time Frame
Pre-treatment, 1st, 3rd, 6th month after injection
Title
Change from nerve conduction velocity on 1st, 3rd, 6th month after injection
Description
Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 3rd, 6th month after injection
Title
Change from cross-sectional area on 1st, 3rd, 6th month after injection
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 3rd, 6th month after injection
Title
Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection
Description
The palmer finger pinch and grasp strength was measured using dynamometer (Fabrication Enterprises Inc., USA) before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 3rd, 6th month after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26218266
Citation
Chang KV, Hung CY, Ozcakar L. Snapping Thumb and Superficial Radial Nerve Entrapment in De Quervain Disease: Ultrasound Imaging/Guidance Revisited. Pain Med. 2015 Nov;16(11):2214-5. doi: 10.1111/pme.12867. Epub 2015 Jul 27. No abstract available.
Results Reference
result
PubMed Identifier
1518514
Citation
Campbell WW, Pridgeon RM, Sahni KS. Short segment incremental studies in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 1992 Sep;15(9):1050-4. doi: 10.1002/mus.880150910.
Results Reference
result
PubMed Identifier
21623291
Citation
Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.
Results Reference
result

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Perineural Injection Therapy for Ulnar Neuropathy at Elbow

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