ُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients

Plain-language guide to NCT03394131: not phased randomized trial of Insulin (regular human), carpal tunnel, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03394131
Phase: not phased
Status: status unknown
Start: 2017-07-01
Completion (planned or actual): 2018-05-01
Participants: 90 (estimated)
Design: randomized, quadruple-blind, treatment
Conditions studied: Treatment Resistant Carpal Tunnel in RA Patients
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Insulin (regular human) for carpal tunnel and insulin resistance, prediabetes & type 2 diabetes.

It had three arms (groups): Hyalase (experimental), Placebo (placebo comparator) and Insilin (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 90 planned participants were the target.

It was open to people of any sex aged from 20 years up to 80 years.

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

Examples of who could join: Rheumatoid arthritis in remission.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: active rheumatoid arthritis.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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, care provider, investigator and outcomes assessor.

It started in 2017-07-01 with completion listed for 2018-05-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): pain intensity (time frame: 6 months).

It also tracked 2 secondary outcomes, for example nerve conduction and ultrasound.

What This Means in Plain Language

Put simply, this is a not phased, 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, Insulin resistance, prediabetes & type 2 diabetes research.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.