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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02986906
Other study ID # PIT for ulnar neuropathy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT04264000 - Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow N/A