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

Primary Purpose

Pain, Neuropathic

Status

Recruiting

Phase

Early Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

hyalase group

midazolam group

About this trial

This is an interventional treatment trial for Pain, Neuropathic

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mina RaoufRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

hyalse group

midazolam group

Arm Description

ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5%

ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5%

Outcomes

Primary Outcome Measures

pain score

visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain

Secondary Outcome Measures

Boston questionnaire

symptom severity ... function severity

median nerve sonogrphy

cross sectional area

Nerve electrophysiology

sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest

Full Information

NCT ID

NCT05344495

First Posted

April 14, 2022

Last Updated

June 11, 2022

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05344495

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 10, 2022 (Actual)

Primary Completion Date

July 20, 2022 (Anticipated)

Study Completion Date

August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Neuropathic

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hyalse group

Arm Type

Active Comparator

Arm Description

ultrasonographic median nerve hydrodissection by hyalase and bupivacaine 0.5%

Arm Title

midazolam group

Arm Type

Active Comparator

Arm Description

ultrasonographic median nerve hydrodissection by midazolam and bupivacaine 0.5%

Intervention Type

Drug

Intervention Name(s)

hyalase group

Other Intervention Name(s)

Sonar guided median nerve hydrodissection by hyalase and bupivacaine 0.5%

Intervention Description

bupivacaine 15 mg 0.5% plus 2 mL normal saline containing 300 international units (IU) hyaluronidase.

Intervention Type

Drug

Intervention Name(s)

midazolam group

Other Intervention Name(s)

Sonar guided median nerve hydrodissection by midazolam and bupivacaine 0.5%

Intervention Description

2 mg midazolam dissolved in 2 ml sterile saline plus 15 mg bupivacaine 0.5%

Primary Outcome Measure Information:

Title

pain score

Description

visual analogue score which represents 0 = no pain, 10= worst un-imaginable pain

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Boston questionnaire

Description

symptom severity ... function severity

Time Frame

6 months

Title

median nerve sonogrphy

Description

cross sectional area

Time Frame

6 months

Title

Nerve electrophysiology

Description

sensory velocity and distal motor latency ... 1m/sec is the least and 10m/sec is the highest

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Mina Raouf

City

ALMinya

State/Province

Minia

ZIP/Postal Code

6115

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

mina raouf

Phone

01015752424

drmina2015@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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