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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorSinai University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40-75 years

Clinically and radiographically confirmed knee osteoarthritis

Moderate to severe pain (VAS ≥ 4)

Willingness to provide informed consent

Disqualifiers

Allergy to bee products or topical agents used in the study

Knee surgery or trauma in the past year

Intra-articular injection in the past 6 months

Other musculoskeletal or systemic conditions affecting the knees (e.g., rheumatoid arthritis)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound therapy unit

    Device

    Ultrasound therapy unit

  • Bee venom topical preparation (for phonophoresis)

    Biological/Vaccine

    Bee venom topical preparation (for phonophoresis)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Bee Venom PhonophoresisExperimental treatment 2 interventions
Group B: Control - Placebo PhonophoresisPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pain Intensity

Measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.

Time frame
Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
2

Change in Functional Mobility

Measured using the Timed Up and Go (TUG) test, which records the time (in seconds) taken for a participant to stand up from a chair, walk 3 meters, turn, return, and sit down. Lower times indicate better mobility.

Time frame
Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).

Secondary outcomes

1

Change in Walking Endurance

Measured using the Six-Minute Walk Test (6MWT), recording the total distance (in meters) walked in six minutes on a flat surface. Greater distances indicate improved endurance.

Time frame
Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).

Other outcomes

Sponsors and contacts

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