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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Insulin
* Drug: Sodium Hyaluronate
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin and Sodium Hyaluronate Ultrasound guided injection<br>Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate | Drug: Insulin<br>* Ultrasound guided perineural injection therapy (PIT)<br>* Other names: Crystalline Insulin;Drug: Sodium Hyaluronate<br>* Ultrasound guided perineural injection therapy (PIT)<br>* Other names: Hyalgan;Device: Ultrasound<br>* Philips Neuromuscular Ultrasound<br>|
| Active Comparator: Insulin Ultrasound guided injection<br>Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin | Drug: Insulin<br>* Ultrasound guided perineural injection therapy (PIT)<br>* Other names: Crystalline Insulin;Device: Ultrasound<br>* Philips Neuromuscular Ultrasound<br>|
| Active Comparator: Sodium Hyaluronate Ultrasound guided injection<br>Subjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate | Drug: Sodium Hyaluronate<br>* Ultrasound guided perineural injection therapy (PIT)<br>* Other names: Hyalgan;Device: Ultrasound<br>* Philips Neuromuscular Ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale | 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 | 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) | 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 | 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 | Ultrasound measured medial nerve cross sectional area difference between pronator | Baseline, 1 month, 3 months | 
| U/S hyper-vascularization of medial nerve percentage | Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel | Baseline, 1 month, 3 months | 
| Sensory nerve conduction velocity of the median nerve | Antidromic sensory nerve conduction velocity of the median nerve | Baseline, 1 month, 3 months |