Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome (PIT)

October 25, 2019 updated by: Khaled Osama Aboshaera, Assiut University

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. The technique of perineural injection therapy (PIT) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help to reduce neuro-inflammation, ischemic damage and allow impulse transmission.

The objective of this study is to evaluate the efficacy of ultrasound guided insulin plus Sodium Hyaluronate injection in reducing symptoms caused by carpal tunnel syndrome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this randomized clinical trial, 90 patients with both a clinical and electromyographic diagnosis of mild to moderate carpal tunnel syndrome will be recruited from Assiut University Hospital (AUH). After obtaining written informed consent, patients will be randomized into three groups. Group A, patients will receive ultrasound-guided PIT with 10 IU of crystalline insulin; Group B, patients will receive ultrasound-guided PIT with 20 mg of Sodium Hyaluronate; Group C, patients will receive ultrasound-guided PIT with 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate. The primary outcome will be the Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale at baseline, 1 month and 3 months post injection. All participants, investigator, outcomes assessor will be blinded (Triple blind)

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 65
  • Understanding written and spoken Arabic consent
  • Diagnostic of carpal tunnel syndrome: Classic of probable based on the Katz Hand Diagram and mild to moderate based on the electrodiagnosis studies

Exclusion Criteria:

  • Diseases known to cause carpal tunnel syndrome: Diabetes mellitus, hypothyroidism, connective tissue disease, rheumatic disease and moderate or severe chronic renal impairment
  • Secondary diagnosis based on the ultrasound: arthrosynovial cyst, flexor tenosynovitis, ganglion
  • Constant symptoms in medial nerve area
  • Thenar eminence atrophy
  • Cervical radiculopathy
  • Brachial plexopathy
  • Thoracic outlet syndrome
  • Polyneuropathy
  • Pregnancy
  • Cognitive disorder
  • Anticoagulant therapy
  • Carpal tunnel injection in the last 6 months
  • Ancient ipsilateral wrist fracture
  • Ancient ipsilateral wrist surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin and Sodium Hyaluronate Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
Drug: Insulin
Ultrasound guided perineural injection therapy (PIT)
Other Names:
  • Crystalline Insulin
Drug: Sodium Hyaluronate
Ultrasound guided perineural injection therapy (PIT)
Other Names:
  • Hyalgan
Device: Ultrasound
Philips Neuromuscular Ultrasound
Active Comparator: Insulin Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin
Drug: Insulin
Ultrasound guided perineural injection therapy (PIT)
Other Names:
  • Crystalline Insulin
Device: Ultrasound
Philips Neuromuscular Ultrasound
Active Comparator: Sodium Hyaluronate Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate
Drug: Sodium Hyaluronate
Ultrasound guided perineural injection therapy (PIT)
Other Names:
  • Hyalgan
Device: Ultrasound
Philips Neuromuscular Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
Time Frame: Baseline, 1 month, 3 months
Boston carpal tunnel syndrome questionnaire - SSS is patient-based questionnaire for measurement of CTS severity which include11 questions to evaluate the symptom severity. Each question ranges from 1 to 5 with a higher score indicating a higher degree of disability.
Baseline, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale
Time Frame: Baseline, 1 month, 3 months
Boston carpal tunnel syndrome questionnaire - FSS is patient-based questionnaire for measurement of CTS functional disability which include 8 items to evaluate the functional status scale (FSS). Each item ranges from 1 to 5 with a higher score indicating a higher degree of disability.
Baseline, 1 month, 3 months
Neuropathic pain Visual Analog Scale (VAS)
Time Frame: Baseline, 1 month, 3 months
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Baseline, 1 month, 3 months
U/S measured medial nerve mean CSA
Time Frame: Baseline, 1 month, 3 months
Ultrasound measured medial nerve mean cross sectional area at the Pisiform bone level
Baseline, 1 month, 3 months
U/S measured medial nerve CSA difference
Time Frame: Baseline, 1 month, 3 months
Ultrasound measured medial nerve cross sectional area difference between pronator
Baseline, 1 month, 3 months
U/S hyper-vascularization of medial nerve percentage
Time Frame: Baseline, 1 month, 3 months
Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel
Baseline, 1 month, 3 months
Sensory nerve conduction velocity of the median nerve
Time Frame: Baseline, 1 month, 3 months
Antidromic sensory nerve conduction velocity of the median nerve
Baseline, 1 month, 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction (Likert scale)
Time Frame: 1month, 3 months
Likert scale with the grade 1 means that the patient's satisfaction was 30%, grade 2, the patient's satisfaction was 30-50%, grade 3, the satisfaction was 50-80%, and grade 4 was 80%, Grades 3 and 4 were defined as "overall satisfied"
1month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Khaled O Aboshaera, MD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutUKAboshaera01

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

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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