NCT02986906|CompletedDMC
Perineural Injection Therapy for Ulnar Neuropathy at Elbow
The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow
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The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow
Sponsor study identifier
interventional
36
1 country
1
Study Start
March 1, 2017
Actual (reported)Primary Completion
October 30, 2019
Actual (reported)Study Completion
October 30, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 6, 2016
Actual (reported)December 8, 2016
Actual (reported)March 1, 2017
Actual (reported)October 30, 2019
Actual (reported)October 30, 2019
Actual (reported)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
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
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)
Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve
Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886, Taiwan
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.
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.
Yung-Tsan Wu, MD
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
36 participants (actual enrollment reported by the registry).
First Submitted
December 6, 2016
First Posted
December 8, 2016
Study Start
March 1, 2017
Actual (reported)The Effect of Hydrodissection for Carpal Tunnel Syndrome
The ultrasound was used for injection guidance
Contact the study team to confirm eligibility.
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.
Primary Completion
October 30, 2019
Actual (reported)Study Completion
October 30, 2019
Actual (reported)Last Updated
November 20, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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