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

NCT07151300 | Not Yet Recruiting DMC

• 1 other identifier: SU.REC.2025(49H)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Osteoarthritis

Keywords

Osteoarthritis; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Change in Walking Endurance

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

Study Arms (2)

Bee Venom Phonophoresis

EXPERIMENTAL

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.

Device: Ultrasound therapy unit; Biological: Bee venom topical preparation (for phonophoresis)

Control - Placebo Phonophoresis

PLACEBO COMPARATOR

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.

Device: Ultrasound therapy unit

Interventions

Ultrasound therapy unit DEVICE

Ultrasound therapy unit

Bee Venom Phonophoresis; Control - Placebo Phonophoresis

Bee venom topical preparation (for phonophoresis) BIOLOGICAL

Bee venom topical preparation (for phonophoresis)

Bee Venom Phonophoresis

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-75 years
• Clinically and radiographically confirmed knee osteoarthritis
• Moderate to severe pain (VAS ≥ 4)
• Willingness to provide informed consent

You may not qualify if:

• 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)
• Pregnancy or contraindication to ultrasound therapy

Sponsors & Collaborators

• Sinai University: lead

Study Sites (1)

Sinai university

Cairo, 44511, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 3, 2025
• Study Start: September 15, 2025
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

EG (1)