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

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ClinicalTrials.gov Identifier: NCT03737916
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Basak Mansiz-Kaplan, Ankara Education and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Ulnar Neuropathies Other: 5 cc 5% Dextrose solution Other: 5 cc salin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: To Evaluate the Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow and to Compare the Control Group
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : August 12, 2020
Estimated Study Completion Date : November 12, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: dextrose group

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

Other: 5 cc 5% Dextrose solution
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).

Placebo Comparator: control group

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.

Other: 5 cc salin
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 Measures :
  1. Change from baseline of pain on 2nd week, 1st and 3rd months after treatment: VAS [ Time Frame: Time Frame: Pre-treatment, 2nd week, 1st and 3rd months after treatment ]
    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 :
  1. Change from baseline in activity and functional status on 2nd week, 1st and 3rd months after treatment. [ Time Frame: Pre-treatment, 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.

  2. Change from baseline in cross-sectional area of the ulnar nerve on 1st and 3th months after treatment. [ Time Frame: Pre-treatment, 2nd week, 1st and 3rd months after treatment treatment ]
    Using the musculoskeletal ultrasonography to measure the cross-sectional area of the ulnar nerve.

  3. Change from baseline in motor nerve conduction velocity of the ulnar nerve [ Time Frame: Pre-treatment, 1st and 3rd months after treatment treatment ]
    Using Electromyography to measure the motor nerve conduction velocity (m/sn) of the ulnar nerve



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03737916


Contacts
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Contact: Basak Mansiz-Kaplan, M.D. +905358582176 basakmansiz@hotmail.com

Locations
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Turkey
Basak Mansiz-Kaplan Recruiting
Ankara, Turkey, 06230
Contact: Basak Mansiz-Kaplan    5358582176    basakmansiz@hotmail.com   
Sponsors and Collaborators
Ankara Education and Research Hospital
Investigators
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Principal Investigator: Basak Mansiz-Kaplan, M.D. Department of Physical Medicine and Rehabilitation

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Responsible Party: Basak Mansiz-Kaplan, Department of Physical Medicine and Rehabilitation (the principal investigator), Ankara Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03737916     History of Changes
Other Study ID Numbers: E171616
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ulnar Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Mononeuropathies