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

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Known diabetes mellitus (Type 1 or uncontrolled Type 2)
• Skin conditions or open wounds at application site
• Hypersensitivity to insulin or gel components
• Use of corticosteroids or NSAIDs within 1 week before enrollment Anterior Cruciate Ligament (ACL) and meniscus injury