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

What Was Tested

This registered early phase 1 trial tested Insulin (regular human) for carpal tunnel.

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel.

It had three arms (groups): Insulin and Sodium Hyaluronate Ultrasound guided injection (experimental), Insulin Ultrasound guided injection (active comparator) and Sodium Hyaluronate Ultrasound guided injection (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

After obtaining written informed consent, patients will be randomized into three groups.

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).

Who Took Part

Enrollment: 90 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the carpal tunnel participants stayed in one arm throughout.

Neither the carpal tunnel participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-11 with completion listed for 2020-05.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale (time frame: Baseline, 1 month, 3 months).

It also tracked 6 secondary outcomes, for example Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale, Neuropathic pain Visual Analog Scale (VAS), U/S measured medial nerve mean CSA, U/S measured medial nerve CSA difference, U/S hyper-vascularization of medial nerve percentage and Sensory nerve conduction velocity of the median nerve.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) in 90 people with carpal tunnel.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Carpal tunnel research.