Efficacy of Topical Insulin Gel as a Coupling Medium in Phonophoresis-Assisted Physiotherapy vs Liposomal Insulin in Management of Joint Inflammation

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

Although most clinical applications of topical insulin have centered on diabetic wound healing, emerging evidence in animal models supports its use in musculoskeletal inflammation.

It had three arms (groups): Insulin gel group (active comparator), Insulin liposomes group (experimental) and phonophoresis only group (placebo comparator).

The registry classes the interventions as drug and radiation.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 40 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Adults aged 40 Years to 60 Years (Adult ). Patient with diagnosis of shoulder soft tissue inflammation due to SAIS/. Unilateral or bilateral grade II shoulder osteoarthritis (clinical and imaging diagnosis X-ray). Patient suffering from shoulder soft tissue inflammation due to SAIS/RCT pain for more than 3 months before enrollment.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: known diabetes mellitus (type 1 or uncontrolled type 2); skin conditions or open wounds at application site; hypersensitivity to insulin or gel components.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the 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 and investigator.

It started in 2025-07-01 with completion listed for 2025-11-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Pain scoring 0-10 (time frame: at 4 an 8 week). Functional Status (time frame: at 4 and 8 week).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.