Sinai university
Cairo, 44511, Egypt
NCT Number: NCT07151300
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.
Trial opening soon.
Get Notified40 year–75 year
All sexes
Interventional
Not applicable
Cairo, 44511, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound therapy unit
Bee venom topical preparation (for phonophoresis)
Time frame: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
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).
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).
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.
Sinai University
Other
Acronym: BEE-KNEE
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