Clinical trial NCT02907671: Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome
Official title: Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome Comparing Two Different Injection Sites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel injection
corticosteroid
ultrasound-guided
musculoskeletal ultrasound
Lead sponsor: Rehabilitace MUDr. Hasan Mezian s.r.o.
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale
timeFrame: up to 1 year
Secondary outcomes:
measure: Michigan Hand Outcomes Measure
timeFrame: up to 1 year
measure: Boston carpal tunnel questionnaire
timeFrame: up to 1 year
measure: Procedural CAS
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Litoměřice
country: Czechia
facility: Kamal Mezian
state: Czech Republic
city: Litomerice
country: Czechia
facility: Kamal Mezian
Study officials:
affiliation: Czech Technical University in Prague, Faculty of Biomedical Engineering, Department of Health Care Disciplines and Population Protection, Sportovců 2311, 272 01 Kladno city, Czech Republic
name: Kamal Mezian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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. No abstract available.
citation: Bodor M, Rojo-Manaute JM, Podnar S. Reply. Muscle Nerve. 2016 Aug;54(2):344-5. doi: 10.1002/mus.25170. No abstract available.