Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05280223
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.8
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine upon the median nerve could offer symptoms and clinical improvement

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome; Pain, Chronic	Drug: Dexmedetomidine; Drug: Hyalase	N/A

Detailed Description

Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dexmedetomidine Versus Hyalase Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Jan 30, 2023
• Anticipated Study Completion Date: Feb 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmeditomidine group injection of 1 microgram/kg dexmedetomidine + 10 cc saline injection nearby median nerve as hydrodissection	Drug: Dexmedetomidine; injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nearby median nerve as hydrodissection
Active Comparator: Hyalase injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection	Drug: Hyalase; injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Outcome Measures

Primary Outcome Measures

1. Pain alleviation [6 months]

   pain alleviation improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10

Secondary Outcome Measures

1. Median nerve cross sectional area [6 months]

   Changes in ultrasound imaging change of cross sectional area in cubic mellimeter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adult patients

• complaining of carpal tunnel syndrome of 3 month duration or more

• diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

• • patient refusal infection at the site of intervention

• local anesthetic allergy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emad Zarief Kamel Said	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emad Zarief , MD, Professor, Assiut University
• ClinicalTrials.gov Identifier: NCT05280223
• Other Study ID Numbers: IRB0002022
• First Posted: Mar 15, 2022
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Syndrome; Chronic Pain; Dexmedetomidine

Study Results

No Results Posted as of Aug 15, 2022