Perineural Injection Therapy for Ulnar Neuropathy at Elbow

NCT02986906 | Completed DMC

• 1 other identifier: PIT for ulnar neuropathy
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulnar Neuropathy at Elbow

Keywords

ulnar neuropathy at elbow; Dextrose; perineural injection

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-treatment, 1st, 3rd, 6th month after injection

Secondary Outcomes (4)

• Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection

  Pre-treatment, 1st, 3rd, 6th month after injection

• Change from nerve conduction velocity on 1st, 3rd, 6th month after injection

  Pre-treatment, 1st, 3rd, 6th month after injection

• Change from cross-sectional area on 1st, 3rd, 6th month after injection

  Pre-treatment, 1st, 3rd, 6th month after injection

• Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection

  Pre-treatment, 1st, 3rd, 6th month after injection

Study Arms (2)

5% dextrose

EXPERIMENTAL

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

Drug: 5% dextrose; Device: Ultrasound

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

ACTIVE COMPARATOR

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

Drug: 2cc 0.9% normal saline+3cc Triamcinolone (30mg); Device: Ultrasound

Interventions

5% dextrose DRUG

Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve

5% dextrose

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

Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve

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

Ultrasound DEVICE

The ultrasound was used for injection guidance

2cc 0.9% normal saline+3cc Triamcinolone (30mg); 5% dextrose

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-80 year-old.
• Diagnosis was confirmed using an electrophysiological study

You may not qualify if:

• Cancer
• Coagulopathy
• Pregnancy
• Inflammation status
• Cervical radiculopathy
• Polyneuropathy, brachial plexopathy
• Thoracic outlet syndrome
• Previously undergone wrist surgery or steroid injection for ulnar neuropathy

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

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

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 26218266 RESULT

• 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.

  PMID: 1518514 RESULT

• 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.

  PMID: 21623291 RESULT

MeSH Terms

Interventions

Glucose; Ultrasonography

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yung-Tsan Wu, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: March 1, 2017
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)