Knee OsteoarthritisBEE-KNEENCT07151300
Phonophoresis With Bee Venom: Evaluating Its Efficacy in Managing Pain and Enhancing Mobility in Knee Osteoarthritis Patients
A study testing Ultrasound therapy unit and Bee venom topical preparation (for phonophoresis) in people with Knee Osteoarthritis and Osteoarthritis, run by Sinai University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Osteoarthritis
- What is being tested?
- Ultrasound therapy unit and Bee venom topical preparation (for phonophoresis)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2026to 25 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-75 years
- Clinically and radiographically confirmed knee osteoarthritis
- Moderate to severe pain (VAS ≥ 4)
- Willingness to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Ultrasound therapy unit, Bee venom topical preparation (for phonophoresis)
- Keywords
- Osteoarthritis, Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound therapy unitDevice
Ultrasound therapy unit
Bee venom topical preparation (for phonophoresis)Biological
Bee venom topical preparation (for phonophoresis)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Ultrasound therapy unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Aug 2026 (estimated)
- Primary completion25 Aug 2027 (estimated)
- Study completion25 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151300
- Sponsor's protocol ID
- SU.REC.2025(49H)
- Acronym
- BEE-KNEE
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phonophoresis With Bee Venom: Evaluating Its Efficacy in Managing Pain and Enhancing Mobility in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT07151300
- Acronym / sponsor ID
- BEE-KNEE / SU.REC.2025(49H)
- Conditions
- Knee Osteoarthritis, Osteoarthritis
- Keywords
- Osteoarthritis, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 25 Dec 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Bee Venom Phonophoresis | Experimental | Device: Ultrasound therapy unit, Biological: Bee venom topical preparation (for 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. |
| Control - Placebo Phonophoresis | Placebo comparator | Device: Ultrasound therapy unitParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-75 years
- Clinically and radiographically confirmed knee osteoarthritis
- Moderate to severe pain (VAS ≥ 4)
- Willingness to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound therapy unitUltrasound therapy unit | Device | Bee Venom Phonophoresis, Control - Placebo Phonophoresis |
| Bee venom topical preparation (for phonophoresis)Bee venom topical preparation (for phonophoresis) | Biological | Bee Venom Phonophoresis |
Primary outcome
Change in Pain Intensity
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.
Change in Functional Mobility
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.
1 secondary outcome
Change in Walking Endurance
Time frame: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound therapy unit and Bee venom topical preparation (for phonophoresis) in people with Knee Osteoarthritis and Osteoarthritis, run by Sinai University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.