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

NCT07790757 | Completed Phase 1

• 1 other identifier: Topical insulin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Inflammation

Outcome Measures

Primary Outcomes (2)

• Pain scoring 0-10

  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).

  at 4 an 8 week

• Functional Status

  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.

  at 4 and 8 week

Study Arms (3)

Insulin gel group

ACTIVE COMPARATOR

Drug: Insulin

Insulin liposomes group

EXPERIMENTAL

Drug: nano-insulin gel

phonophoresis only group

PLACEBO COMPARATOR

Radiation: phonophoresis and ultasound

Interventions

Insulin DRUG

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

Insulin gel group

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

Insulin liposomes group

phonophoresis and ultasound RADIATION

combination of ultrasound and phonophoresis without insulin

phonophoresis only group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Deraya university, physiotherapy clinics

Minya, 05673, Egypt

Location

MeSH Terms

Conditions

Arthritis

Interventions

Insulin; Phonophoresis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: August 27, 2026
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

EG (1)