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

Assiut University

Status and phase: Unknown; Early Phase 1

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Sodium Hyaluronate; Drug: Insulin; Device: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04142411

AssiutUKAboshaera01

Details and patient eligibility

About

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.

Full 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)

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Insulin and Sodium Hyaluronate Ultrasound guided injection

Experimental group

Description:

Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate

Treatment:

Device: Ultrasound

Drug: Sodium Hyaluronate

Drug: Insulin

Insulin Ultrasound guided injection

Active Comparator group

Description:

Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin

Treatment:

Device: Ultrasound

Drug: Insulin

Sodium Hyaluronate Ultrasound guided injection

Active Comparator group

Description:

Subjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate

Treatment:

Device: Ultrasound

Drug: Sodium Hyaluronate