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

NCT03675295 | Completed

• 1 other identifier: IRB00009921
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• pain alleviation

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

  6 months

Secondary Outcomes (2)

• Changes in ultrasound imaging

  6 months

• Changes in median nerve conduction parameters

  6 months

Study Arms (2)

Comparator: Hyalase

ACTIVE COMPARATOR

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Drug: Hyalase

Saline

ACTIVE COMPARATOR

Injection 10 cc saline injection as a median nerve hydro-dissection

Drug: Saline

Interventions

Hyalase DRUG

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Comparator: Hyalase

Saline DRUG

injection of 10 cc saline injection nearby median nerve as hydro-dissection

Saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• complaining of carpal tunnel syndrome of 3 month duration or more
• diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

You may not qualify if:

• patient refusal
• infection at the site of intervention
• local anesthetic allergy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia, ICU, and pain

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 18, 2018
• Study Start: April 2, 2017
• Primary Completion: March 20, 2018
• Study Completion: July 1, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)