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NCT Number: NCT07790757

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

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.

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Key information

Conditions

Joint Inflammation Arthritis Joint Diseases Musculoskeletal Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Deraya university, physiotherapy clinics

Minya, 05673, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

Topical insulin gel (2 IU/g) applied with phonophoresis technique

nano-insulin gel

Drug

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

Radiation

combination of ultrasound and phonophoresis without insulin

Primary outcomes

  1. Pain scoring 0-10

    Time frame: at 4 an 8 week

    The visual analog scale (VAS) is a pain rating scale first used. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  2. Functional Status

    Time frame: at 4 and 8 week

    Shoulder/Upper Limb: DASH Questionnaire, Shoulder pain and disability measured with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire (the score output is given as a percentage -from 0% to 100%- and the lower the percentage the better is the clinical outcome, the higher the percentage the worse is the clinical outcome) performed at 2, 4, 6 and at 12 weeks after treatment start compared to baseline.

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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