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The Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow

Primary Purpose

Ulnar Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
5 cc 5% Dextrose solution
5 cc salin
Sponsored by
Ankara Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulnar Neuropathies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18-65 year-old.
  • Neuropathic pain on the ulnar nerve distribution area for at least 1 months
  • Diagnosis was confirmed using an electrophysiological studies and ultrasonography

Exclusion Criteria:

  • History of trauma to the upper extremity
  • Central or peripheral neurologic disease
  • Electromyography (EMG)-proven carpal tunnel syndrome, radiculopathy or any other neuropathy
  • Pregnancy or any systemic disease that might cause swelling on nerves (e.g., diabetes -mellitus, renal failure, and thyroid disease)
  • USG-detected bifid or trifid median nerve, persistent median artery, or space-occupying lesions

Sites / Locations

  • Basak Mansiz-Kaplan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dextrose group

control group

Arm Description

Procedure: Ultrasound-guided perineural injection with 5% dextrose. Ultrasound-guided perineural injection with 5% Dextrose (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc). Drug: 5% Dextrose 5% Dextrose could decrease the release of CGRP (Calcitonin Gene Related Peptide) and substance P to reduce the nerve inflammation

Procedure: Perineural injection with normal saline Ultrasound-guided perineural injection with normal saline (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc). Drug: Normal Saline Normal saline is safe for perineural injection.

Outcomes

Primary Outcome Measures

Change from baseline of pain on 2nd week, 1st and 3rd months after treatment: VAS
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.

Secondary Outcome Measures

Change from baseline in activity and functional status on 2nd week, 1st and 3rd months after treatment.
Using the Quick-DASH to measure the activity and functional status before treatment and multiple time frame after treatment. The Quick-DASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The higher scores indicate worse functional status.
Change from baseline in cross-sectional area of the ulnar nerve on 1st and 3th months after treatment.
Using the musculoskeletal ultrasonography to measure the cross-sectional area of the ulnar nerve.
Change from baseline in motor nerve conduction velocity of the ulnar nerve
Using Electromyography to measure the motor nerve conduction velocity (m/sn) of the ulnar nerve

Full Information

First Posted
November 6, 2018
Last Updated
August 21, 2022
Sponsor
Ankara Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03737916
Brief Title
The Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow
Official Title
To Evaluate the Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow and to Compare the Control Group
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Ulnar neuropathy at the elbow (UNE) is the second most common neuropathy and occurs after recurrent or elongated elbow flexion. Diagnosis of UNE depends on clinical symptoms, physical examination, and electrophysiological findings. Imaging methods such as ultrasonography (USG) and magnetic resonance imaging show cross-sectional area and echogenicity of ulnar nerve and give information about to surrounding structures around the ulnar nerve. In mild and moderate cases, conservative treatments are administered up to 6 months, who do not benefit from conservative treatment are referred to surgery. There are not many options for conservative treatment. Activity modification, nerve gliding exercises and night splints are conservative treatment methods. Steroid injection is no longer recommended. Perineural dextrose injection is applied in tendinopathies and entrapment neuropathies (especially carpal tunnel syndrome). In the literature, there is no study showing effect of perineural dextrose injection in patients with UNE. The investigators design a randomized, double-blind, controlled trail to evaluate the effect after ultrasound-guided perineural injection with 5% dextrose in patients with UNE.
Detailed Description
After obtaining written informed consent, patients of clinically diagnosed with UNE were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Quick-DASH (Disabilities of Arm, Shoulder and Hand), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity and distal latency of the ulnar nerve. The evaluation was performed pretreatment as well as on the 2nd week, 1st and 3rd month after the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Neuropathies

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
dextrose group
Arm Type
Experimental
Arm Description
Procedure: Ultrasound-guided perineural injection with 5% dextrose. Ultrasound-guided perineural injection with 5% Dextrose (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc). Drug: 5% Dextrose 5% Dextrose could decrease the release of CGRP (Calcitonin Gene Related Peptide) and substance P to reduce the nerve inflammation
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Procedure: Perineural injection with normal saline Ultrasound-guided perineural injection with normal saline (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc). Drug: Normal Saline Normal saline is safe for perineural injection.
Intervention Type
Other
Intervention Name(s)
5 cc 5% Dextrose solution
Intervention Description
Ultrasound-guided perineural injection with 5% Dextrose (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).
Intervention Type
Other
Intervention Name(s)
5 cc salin
Intervention Description
Ultrasound-guided perineural injection with salin (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).
Primary Outcome Measure Information:
Title
Change from baseline of pain on 2nd week, 1st and 3rd months after treatment: VAS
Description
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.
Time Frame
Time Frame: Pre-treatment, 2nd week, 1st and 3rd months after treatment
Secondary Outcome Measure Information:
Title
Change from baseline in activity and functional status on 2nd week, 1st and 3rd months after treatment.
Description
Using the Quick-DASH to measure the activity and functional status before treatment and multiple time frame after treatment. The Quick-DASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The higher scores indicate worse functional status.
Time Frame
Pre-treatment, 2nd week, 1st and 3rd months after treatment
Title
Change from baseline in cross-sectional area of the ulnar nerve on 1st and 3th months after treatment.
Description
Using the musculoskeletal ultrasonography to measure the cross-sectional area of the ulnar nerve.
Time Frame
Pre-treatment, 2nd week, 1st and 3rd months after treatment treatment
Title
Change from baseline in motor nerve conduction velocity of the ulnar nerve
Description
Using Electromyography to measure the motor nerve conduction velocity (m/sn) of the ulnar nerve
Time Frame
Pre-treatment, 1st and 3rd months after treatment treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-65 year-old. Neuropathic pain on the ulnar nerve distribution area for at least 1 months Diagnosis was confirmed using an electrophysiological studies and ultrasonography Exclusion Criteria: History of trauma to the upper extremity Central or peripheral neurologic disease Electromyography (EMG)-proven carpal tunnel syndrome, radiculopathy or any other neuropathy Pregnancy or any systemic disease that might cause swelling on nerves (e.g., diabetes -mellitus, renal failure, and thyroid disease) USG-detected bifid or trifid median nerve, persistent median artery, or space-occupying lesions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basak Mansiz-Kaplan, M.D.
Organizational Affiliation
Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Basak Mansiz-Kaplan
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

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The Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow

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