Phonophoresis With Bee Venom: Evaluating Its Efficacy in Managing Pain and Enhancing Mobility in Knee Osteoarthritis Patients

Sponsor
Sinai University
Study ID
NCT07151300
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound therapy unit — DEVICE
    Ultrasound therapy unit
  • Bee venom topical preparation (for phonophoresis) — BIOLOGICAL
    Bee venom topical preparation (for phonophoresis)

Study Details

Brief Summary: This single-blind, randomized controlled trial will investigate the efficacy of bee venom phonophoresis in managing pain and improving mobility in patients with knee osteoarthritis. Thirty adults aged 40-75 years with clinically and radiographically confirmed knee osteoarthritis will be randomly assigned to receive either bee venom phonophoresis or placebo phonophoresis with a neutral gel. Ultrasound parameters will be standardized for all participants. Primary outcomes are pain reduction, measured by the Visual Analog Scale (VAS), and functional mobility, assessed by the Timed Up and Go (TUG) test. The secondary outcome is walking endurance, measured by the Six-Minute Walk Test (6MWT). Assessments will be conducted at baseline and post-intervention. The study is designed to determine whether bee venom phonophoresis offers greater clinical benefit compared to placebo phonophoresis, potentially providing a non-invasive, adjunctive treatment option for knee osteoarthritis. Ethical approval has been obtained from the Faculty of Physical Therapy, Sinai University, and all participants will provide written informed consent.

Key Dates

First listed
Sep 3, 2025
Start date
May 15, 2026
Status verified
May 2026
Primary completion
Aug 25, 2026
Completion
Dec 25, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bee Venom Phonophoresis
    Participants receive bee venom phonophoresis therapy applied to the affected knee(s) using standardized ultrasound parameters. Bee venom topical preparation will be mixed with ultrasound coupling gel and applied to the treatment area. Ultrasound will be delivered at a standardized frequency, intensity, and duration determined before study commencement.
  • Placebo Comparator: Control - Placebo Phonophoresis
    Participants receive placebo phonophoresis using the same ultrasound parameters as the experimental group, but with a neutral coupling gel that does not contain bee venom. This ensures the same patient experience without the active bee venom component.

Primary Outcome Measure

Change in Pain Intensity [ Time Frame: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4). ]

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