ُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients

Not Applicable

• Conditions: Treatment Resistant Carpal Tunnel in RA Patients
• Interventions: Other: saline; Drug: Insulin; Drug: Hylase

• Registration Number: NCT03394131
• Lead Sponsor: Assiut University

Brief Summary

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection using insulin versus hyalase versus saline, ultrasounic guided as an effective treatment

Detailed Description

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection of median nerve inside CT twice injections with interval 2 weeks using insulin and 10 cc saline versus hyalase and 10 cc saline versus 10 cc saline, ultrasounic guided as an effective treatment of CT

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-12-25
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Primary Completion: 2018-05-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13
• Study Completion: 2018-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Rheumatoid arthritis in remission

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Exclusion Criteria

• active Rheumatoid arthritis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	saline	injection and hydro-dissection of median nerve hydro-dissection using 10 cc saline injection ultrasonic guided
Insilin	Insulin	injection and hydro-dissection of median nerve hydro-dissection using 10 IU insuline followed by 10 cc normal saline ultrasonic guided
Hyalase	Hylase	injection and hydro-dissection of median nerve using hyaluronidase followed by 10 cc normal saline ultrasonic guided

Primary Outcome Measures

Name	Time	Method
pain intensity	6 months	Visual analog scale 0-100

Secondary Outcome Measures

Name	Time	Method
nerve conduction	6 months	sensory velocity
ultrasound	6 months	cross sectional area

Trial Locations

Locations (1)

Manal Hassanien; 🇪🇬 Assiut, Assuit, Egypt