Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03675295
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 4

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 of the median nerve could offer symptoms and clinical improvement

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Drug: Hyalase; Drug: Saline	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
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Investigate if, and to what extent, hydro-dissection using Hyalase versus saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.Investigate if, and to what extent, hydro-dissection using Hyalase versus saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial
• Actual Study Start Date: Apr 2, 2017
• Actual Primary Completion Date: Mar 20, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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
Active Comparator: Saline Injection 10 cc saline injection as a median nerve hydro-dissection	Drug: Saline; injection of 10 cc saline injection nearby median nerve as hydro-dissection

Outcome Measures

Primary Outcome Measures

1. pain alleviation [6 months]

   visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Secondary Outcome Measures

1. Changes in ultrasound imaging [6 months]

   change of cross sectional area of the median nerve

2. Changes in median nerve conduction parameters [6 months]

   distal motor latency, sensory nerve conduction velocity,peak sensory latency

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 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, Associate professor of Anesthesia, ICU, and pain, Assiut University
• ClinicalTrials.gov Identifier: NCT03675295
• Other Study ID Numbers: IRB00009921
• First Posted: Sep 18, 2018
• Last Update Posted: Sep 18, 2018
• Last Verified: Sep 1, 2018

• 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

Study Results

No Results Posted as of Sep 18, 2018