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NCT05344495 Clinical Trial

Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome:

Pain, Neuropathic Clinical Trial

Official title:
Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: A Randomized, Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05344495
Other study ID # 277/4-2022
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 10, 2022
Est. completion date August 1, 2022

Study information
Verified date June 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 1, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria: - adult patients (30 - 70 years old) complaining of carpal tunnel syndrome of 3 month duration or more , diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study refractory to medical treatment for 2 months . Exclusion Criteria: - Diabetic patients - Pregnant population . - Refusal to participate

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• hyalase group
bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.
• midazolam group
2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%

Locations
Country Name City State
Egypt Mina Raouf ALMinya Minia

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain score visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain 6 months
Secondary Boston questionnaire symptom severity ... function severity 6 months
Secondary median nerve sonogrphy cross sectional area 6 months
Secondary Nerve electrophysiology sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest 6 months
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