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

Early Phase 1

• Conditions: Pain, Neuropathic
• Interventions: Drug: hyalase group; Drug: midazolam group

• Registration Number: NCT05344495
• Lead Sponsor: Minia University

Brief Summary

Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-10
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-25
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-11
• Last Update Posted: 2022-06-15
• Primary Completion: 2022-07-20
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyalse group	hyalase group	ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5%
midazolam group	midazolam group	ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5%

Primary Outcome Measures

Name	Time	Method
pain score	6 months	visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain

Secondary Outcome Measures

Name	Time	Method
Boston questionnaire	6 months	symptom severity ... function severity
Nerve electrophysiology	6 months	sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest
median nerve sonogrphy	6 months	cross sectional area

Trial Locations

Locations (1)

Mina Raouf; 🇪🇬 ALMinya, Minia, Egypt