Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Ulnar Neuropathy at Elbow Clinical Trial

Official title:

The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986906
• Other study ID #: PIT for ulnar neuropathy
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: November 2019
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Ulnar Neuropathies
• Ulnar Neuropathy at Elbow

Intervention

Drug:
• 5% dextrose
Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve
• 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve

Device:
• Ultrasound
The ultrasound was used for injection guidance

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

Chang KV, Hung CY, Özçakar 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Pre-treatment, 1st, 3rd, 6th month after injection
Secondary	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.	Pre-treatment, 1st, 3rd, 6th month after injection
Secondary	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.	Pre-treatment, 1st, 3rd, 6th month after injection
Secondary	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.	Pre-treatment, 1st, 3rd, 6th month after injection