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

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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Hyalase; Drug: Saline

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Emad Zarief Kamel Said

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain alleviation	visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ultrasound imaging	change of cross sectional area of the median nerve	6 months
Changes in median nerve conduction parameters	distal motor latency, sensory nerve conduction velocity,peak sensory latency	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2017
• Primary Completion (ACTUAL): March 20, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 15, 2018
• First Posted (ACTUAL): September 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 15, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: IRB00009921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No