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

NCT ID: NCT07151300

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2025-12-25

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.

Detailed Description

Detailed Description:

Knee osteoarthritis (OA) is a chronic, degenerative joint disease characterized by cartilage loss, joint space narrowing, pain, stiffness, and functional impairment. It is a leading cause of disability worldwide, particularly among older adults. Conventional management includes pharmacologic interventions such as oral analgesics and nonsteroidal anti-inflammatory drugs, and non-pharmacologic approaches such as exercise therapy and physiotherapy. However, these treatments may not provide adequate symptom relief and can be associated with side effects, prompting the search for alternative or adjunctive therapies.

Phonophoresis, an ultrasound-based technique that enhances transdermal drug delivery, has been investigated as a non-invasive intervention for musculoskeletal pain management. Bee venom, used in traditional medicine for inflammatory and arthritic conditions, possesses anti-inflammatory, analgesic, and immunomodulatory properties. Combining bee venom with phonophoresis may enhance penetration into periarticular tissues, potentially improving clinical outcomes in OA patients.

This single-blind, randomized controlled trial will enroll 30 adults aged 40-75 years with clinically and radiographically confirmed knee osteoarthritis. Participants will be randomly allocated to one of two groups:

Experimental group: Bee venom phonophoresis using standardized ultrasound parameters (frequency, intensity, duration).

Control group: Placebo phonophoresis using identical ultrasound settings but with a neutral gel lacking bee venom.

Primary outcomes include pain reduction assessed 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). Outcomes will be evaluated at baseline and after the intervention period.

Data will be analyzed using appropriate descriptive and inferential statistics, with between-group comparisons conducted using independent t-tests or nonparametric equivalents, and within-group comparisons using paired t-tests or Wilcoxon signed-rank tests. Statistical significance will be set at p < 0.05.

Ethical approval has been obtained from the Faculty of Physical Therapy, Sinai University. Written informed consent will be obtained from all participants before enrollment. The trial will adhere to the principles of the Declaration of Helsinki and ICH-GCP guidelines to ensure participant safety, data integrity, and scientific validity.

Conditions

Knee Osteoarthritis; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound therapy unit

Intervention Type: DEVICE

Ultrasound therapy unit

Bee venom topical preparation (for phonophoresis)

Intervention Type: BIOLOGICAL

Bee venom topical preparation (for phonophoresis)

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.

Group Type: PLACEBO_COMPARATOR

Ultrasound therapy unit

Intervention Type: DEVICE

Ultrasound therapy unit

Interventions

Ultrasound therapy unit

Ultrasound therapy unit

Intervention Type: DEVICE

Bee venom topical preparation (for phonophoresis)

Bee venom topical preparation (for phonophoresis)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinai University

OTHER

Sponsor Role: lead

Responsible Party

Amany Gomaa Atiaa

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sinai university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

SU.REC.2025(49H)

Identifier Type: -

Identifier Source: org_study_id