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Efficacy of Topical Insulin Gel as a Coupling Medium in Phonophoresis-Assisted Physiotherapy vs Liposomal Insulin in Management of Joint Inflammation
Sponsor: Deraya University
Summary
Although most clinical applications of topical insulin have centered on diabetic wound healing, emerging evidence in animal models supports its use in musculoskeletal inflammation. In osteoarthritic models, insulin was shown to downregulate cartilage-degrading enzymes (MMP-1, MMP-13, ADAMTS4) in synovial fibroblasts by activating the insulin receptor and PI3K/Akt signaling pathways, indicating direct synovial anti-inflammatory effects3. From a physiotherapeutic perspective, therapeutic ultrasound facilitates deeper tissue heating and enhances local circulation, potentially improving the dermal and transdermal absorption of topically applied agents. Therefore, using insulin in gel form as a coupling medium offers dual benefits: enhanced drug delivery via ultrasound and localized modulation of inflammatory processes in joints and soft tissues. This synergy could lead to superior pain relief and functional recovery compared to standard ultrasound gel. * Primary Objective: To evaluate the effect of topical nano-insulin gel on pain reduction and functional improvement compared to standard insulin gel combined with the Phonophoresis technique. * Secondary Objectives: To assess quality of life markers as changes in joint mobility, strength, and incidence of local/systemic adverse effects.
Official title: Efficacy of Topical Insulin Gel as a Coupling Medium in Phonophoresis-Assisted Physiotherapy vs Liposomal Insulin in Management of Joint Inflammation: A Randomized, Double-Blind Controlled Trial
Key Details
Gender
All
Age Range
40 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-07-01
Completion Date
2026-02-01
Last Updated
2026-08-27
Healthy Volunteers
Yes
Conditions
Interventions
Insulin
Topical insulin gel (2 IU/g) applied with phonophoresis technique
nano-insulin gel
Transferosomes were formulated by the conventional handshaking method using Phos-pholipid (soylecithin) and surfactant (sodium deoxycholate) are mixed with chloroform in the ratio 1:1:1
phonophoresis and ultasound
combination of ultrasound and phonophoresis without insulin
Locations (1)
Deraya university, physiotherapy clinics
Minya, Egypt