Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome Comparing Two Different Injection Sites

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02907671
• Other study ID #: 111
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2016
• Last updated: April 17, 2018
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Rehabilitace MUDr. Hasan Mezian s.r.o.
• Contact: Kamal Mezian, M.D.
• Phone: 00420603313207
• Email: kamal.mezian[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome treatment comparing two different injection sites. Single-blind randomized trial.

Description:

Carpal tunnel syndrome (CTS) is the most common nerve entrapment neuropathy. Six placebo-controlled trials with 393 participants proved corticosteroid injection to be effective in symptom relief. However, all injections were palpation-guided. Therefore, the exact injection site was uncertain. Although three studies comparing palpation and ultrasound (US) guided CTS injection showed US superiority, the optimal injection site for the injectate delivery remains unclear. Some authors believe in thinning of the flexor tenosynovium as the mechanism of the median nerve decompression, and therefore recommend injection between the tendons, away from the nerve. Other authors stress the importance of hydrodissection and direct contact of the injectate with the nerve and suggest injection targeting the median nerve. According to our best knowledge, no study comparing different injection sites for a corticosteroid delivery in CTS has been published in English written literature. The objective of this study was to determine the optimal target site for the corticosteroid delivery in CTS injection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• primary idiopathic CTS

• symptoms of classic or probable CTS (numbness or tingling in at least 2 of the 4 radial fingers)

• unsuccessful 1-month treatment with wrist splinting

• nerve conduction test results that showed median neuropathy at the wrist

Exclusion Criteria:

• previous steroid injection

• diabetes mellitus,

• thyroid disorder

• inflammatory disease

• polyneuropathy

• current pregnancy

• previous carpal tunnel surgery

• severe illness

• inability to respond to questionnaires

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• carpal tunnel corticoanesthetic injection
Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)

Locations

Country	Name	City	State
Czechia	Kamal Mezian	Litomerice	Czech Republic
Czechia	Kamal Mezian	Litomerice

Sponsors (1)

Lead Sponsor	Collaborator
Rehabilitace MUDr. Hasan Mezian s.r.o.

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

Bodor M, Rojo-Manaute JM, Podnar S. Reply. Muscle Nerve. 2016 Aug;54(2):344-5. doi: 10.1002/mus.25170. — View Citation

Mezian K, Bruthans J. Why do local corticosteroid injections work in carpal tunnel syndrome, But not in ulnar neuropathy at the elbow? Muscle Nerve. 2016 Aug;54(2):344. doi: 10.1002/mus.25171. Epub 2016 May 26. — View Citation

Podnar S, Omejec G. Why do local corticosteroid injections work in carpal tunnel syndrome, but not in ulnar neuropathy at the elbow? Muscle Nerve. 2016 Apr;53(4):662-3. doi: 10.1002/mus.24956. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale	pain severity scale	up to 1 year
Secondary	Michigan Hand Outcomes Measure	Hand function status	up to 1 year
Secondary	Boston carpal tunnel questionnaire	Hand function status	up to 1 year
Secondary	Procedural CAS	discomfort during the internetion	up to 1 year