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

Early Phase 1
Conditions
Carpal Tunnel Syndrome
Interventions
Registration Number
NCT04142411
Lead Sponsor
Assiut University
Brief Summary

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

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)

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
90
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sodium Hyaluronate Ultrasound guided injectionUltrasoundSubjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate
Insulin Ultrasound guided injectionInsulinSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin
Insulin Ultrasound guided injectionUltrasoundSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin
Sodium Hyaluronate Ultrasound guided injectionSodium HyaluronateSubjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate
Insulin and Sodium Hyaluronate Ultrasound guided injectionInsulinSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
Insulin and Sodium Hyaluronate Ultrasound guided injectionUltrasoundSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
Insulin and Sodium Hyaluronate Ultrasound guided injectionSodium HyaluronateSubjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
Primary Outcome Measures
NameTimeMethod
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity ScaleBaseline, 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.

Secondary Outcome Measures
NameTimeMethod
Boston Carpal Tunnel Syndrome Questionnaire - Functional Status ScaleBaseline, 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.

Neuropathic pain Visual Analog Scale (VAS)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.

U/S measured medial nerve mean CSABaseline, 1 month, 3 months

Ultrasound measured medial nerve mean cross sectional area at the Pisiform bone level

U/S measured medial nerve CSA differenceBaseline, 1 month, 3 months

Ultrasound measured medial nerve cross sectional area difference between pronator

U/S hyper-vascularization of medial nerve percentageBaseline, 1 month, 3 months

Percentage of Ultrasound hyper-vascularization of medial nerve in carpal tunnel

Sensory nerve conduction velocity of the median nerveBaseline, 1 month, 3 months

Antidromic sensory nerve conduction velocity of the median nerve

Trial Locations

Locations (1)

Medicine

🇪🇬

Assiut, Egypt

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