Complications; C, Intestinal (Internal)NCT05286463
Effect of Ultrasound-enhanced Bee Venom on Selected Post Inguinal Hernioplasty Complications
A study testing bee venom gel phonophoresis and low intensity ultrasound in people with Complications; C, Intestinal (Internal), run by Cairo University at 1 site in Egypt.
Trial summary
Objectives: Bee venom phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and to reduce postoperative pain. The aim of this study was to evaluate the effect of bee venom phonophoresis on selected acupuncture points for the treatment of pain, inflammation, and mobility of… Read more about this study
- Who is it for?
- Ages 28 to 50 years, men only
- Conditions the study is for
- Complications; C, Intestinal (Internal)
- What is being tested?
- bee venom gel phonophoresis and low intensity ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients ranged in age from 28 to 50 years old.
- They had not previously undertaken another physical therapy modality for pain
- Non-smokers
- Under their own prescribed medications described by their physicians.
Who cannot join
- had non-mesh inguinal hernioplasty.
- suffered from open or infected wounds.
- had any systemic diseases that may interfere with the study's objectives such as using chemo or radiotherapy.
- had allergy to bee venom.
- had associated disorders, such as immunodeficiency, HIV, diabetes, or anemia.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: Bee venom phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and to reduce postoperative pain. The aim of this study was to evaluate the effect of bee venom phonophoresis on selected acupuncture points for the treatment of pain, inflammation, and mobility of the hip following inguinal hernioplasty.
HYPOTHESES:
It will be hypothesized that:
It was hypothesized that Bee venom phonophoresis has no or limited effect in improvement of post inguinal hernioplasty complication.
RESEARCH QUESTION: Does Bee venom phonophoresis an effect in improvement of post inguinal hernioplasty complication?
Read the detailed description
All patients in both groups of the study (A) and (B) would receive a noncontact low-frequency pulsed ultrasound delivered through a fine mist of sterile saline or alcohol at the incisional site of inguinal hernioplasty, REN 4 and REN 6. Treatment sessions were 3 sessions a week for 3 consecutive weeks. Before and after each patient exposure, the ultrasonic applicator's performance was tested on a regular basis, and each test included all essential acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of the field distribution.
Ren 4: On the anterior midline, 2 sun superior to the upper border of the pubic symphysis or 3 sun inferior to the umbilicus. Ren 6: On the anterior midline, 1.5 sun inferior to the umbilicus or 3.5 sun superior to the upper border of the pubic symphysis.
For the bee venom phonophoresis group (A): A single clinical dosage of diluted bee venom (BV) in normal saline, 0.05 ml (1 g/ml), was injected into the forearm via either an intradermal or subcutaneous method to test for BV allergy. Subjects might take part in this study if the examined lesion caused a wheal with a diameter of less than 10 mm and an erythema with a diameter of less than 26.5 mm after 10 to 15 minutes.28 Participants were treated with BV previously prepared gel as topical application using an ultrasonic therapy instrument with frequency, 0.5-megahertz pulsed mode (applicator 1.9 cm2) applied around the incision site. The movement was over the incision margins with a pulsed duty cycle of 40% (4 ms on, 6 ms off), and power density of 0.5 W/cm2, and time was 5 minutes each session. Each participant was put in the most comfortable and relaxed position as a supine lying position, and the patient was asked to expose the incision site to avoid any restriction for receiving phonophoresis around the incisional site, REN 4 and REN 6. The incision margin was cleaned with alcohol or normal saline, the ultrasound unit's plug was inserted into the main current supply, and the treatment approach (phonophoresis application for bee venom gel) was prepared; each participant received a total amount of about 0.6 mg to 1 mg of BV gel each session for a total of 5 minutes.29 The participants in the control group (Group B) received only low-intensity pulsed ultrasound applied around the incisional site, REN 4 and REN 6 for 5 minutes, as in Group A, using only plain gel without BV gel.
- Conditions
- Complications; C, Intestinal (Internal)
- Being tested
- bee venom gel phonophoresis, low intensity ultrasound
- Keywords
- phonophoresis, inguinal hernioplasty, bee venom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bee venom gel phonophoresisCombination product
Also called low intensity Ultrasound with bee venom gel
a noncontact low-frequency pulsed ultrasound delivered through Bee Venom previously prepared gel as topical application using an ultrasonic therapy instrument with frequency, 0.5-MHZ pulsed mode (applicator 1.9 cm2) applied around the incision site, Ren 4 and Ren 6. The movement was over the incision margins, Ren 4 and Ren 6 with a pulsed duty cycle of 40% (4 ms on, 6 ms off), and power density of 0.5 W/cm2, Before and after each patient exposure, the ultrasonic applicator's performance was tested on a regular basis, and each test included all essential acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of the field distribution.
low intensity ultrasoundDevice
a noncontact low-frequency pulsed ultrasound delivered through plain gel only using an ultrasonic therapy instrument with frequency, 0.5-MHZ pulsed mode (applicator 1.9 cm2) applied around the incision site, Ren 4 and Ren 6. The movement was over the incision margins, Ren 4 and Ren 6 with a pulsed duty cycle of 40% (4 ms on, 6 ms off), and power density of 0.5 W/cm2, Before and after each patient exposure, the ultrasonic applicator's performance was tested on a regular basis, and each test included all essential acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of the field distribution.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | received low-intensity pulsed ultrasound using bee venom (BV) gel for 5 minutes for each session, three times a week, for three consecutive weeks postoperative and received regular medical care. Receives: Combination Product: bee venom gel phonophoresis |
| group B | Sham comparator | received low-intensity pulsed ultrasound using only plain gel without BV gel for 5 minutes for each session, three times a week, for three consecutive weeks postoperative and received regular medical care. Receives: Device: low intensity ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum C-reactive protein (CRP)
blood sample analyzed at laboratory unit
Measured: change in CRP calculated at post-3 weeks of treatment minus baseline.
Manual Goniometer
A simple long-arm goniometer with a 360° scale marked in one-degree increments was used. A manual goniometer was used for assessment of hip flexion, extension, abduction, and adduction range of motion (ROM).
Measured: change in ranges of motion calculated at post-3 weeks of treatment minus baseline.
The visual analogue scale (VAS)
The visual analogue scale (VAS) is a 10-cm-long line with the ends labelled as the pain extremes (e.g., no pain to unbearable pain). Between "no pain" and "worst pain," patients were asked to mark the spot on the line that best described their pain experience. The operator then measured in millimetres the gap between zero and "no pain".
Measured: change in VAS calculated at post-3 weeks of treatment minus baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start2 Mar 2021
- Primary completion5 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; C, Intestinal (Internal)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed othman, Cairo University
- Investigators
- eman othman, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286463
- Sponsor's protocol ID
- /012/002764
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-enhanced Bee Venom on Selected Post Inguinal Hernioplasty Complications
- ClinicalTrials.gov ID
- NCT05286463
- Acronym / sponsor ID
- /012/002764
- Conditions
- Complications; C, Intestinal (Internal)
- Keywords
- phonophoresis, inguinal hernioplasty, bee venom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 18 Mar 2022 (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.
Objectives: Bee venom phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and to reduce postoperative pain. The aim of this study was to evaluate the effect of bee venom phonophoresis on selected acupuncture points for the treatment of pain, inflammation, and mobility of the hip following inguinal hernioplasty.
HYPOTHESES:
It will be hypothesized that:
It was hypothesized that Bee venom phonophoresis has no or limited effect in improvement of post inguinal hernioplasty complication.
RESEARCH QUESTION: Does Bee venom phonophoresis an effect in improvement of post inguinal hernioplasty complication?
Detailed description
All patients in both groups of the study (A) and (B) would receive a noncontact low-frequency pulsed ultrasound delivered through a fine mist of sterile saline or alcohol at the incisional site of inguinal hernioplasty, REN 4 and REN 6. Treatment sessions were 3 sessions a week for 3 consecutive weeks. Before and after each patient exposure, the ultrasonic applicator's performance was tested on a regular basis, and each test included all essential acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of the field distribution.
Ren 4: On the anterior midline, 2 sun superior to the upper border of the pubic symphysis or 3 sun inferior to the umbilicus. Ren 6: On the anterior midline, 1.5 sun inferior to the umbilicus or 3.5 sun superior to the upper border of the pubic symphysis.
For the bee venom phonophoresis group (A): A single clinical dosage of diluted bee venom (BV) in normal saline, 0.05 ml (1 g/ml), was injected into the forearm via either an intradermal or subcutaneous method to test for BV allergy. Subjects might take part in this study if the examined lesion caused a wheal with a diameter of less than 10 mm and an erythema with a diameter of less than 26.5 mm after 10 to 15 minutes.28 Participants were treated with BV previously prepared gel as topical application using an ultrasonic therapy instrument with frequency, 0.5-megahertz pulsed mode (applicator 1.9 cm2) applied around the incision site. The movement was over the incision margins with a pulsed duty cycle of 40% (4 ms on, 6 ms off), and power density of 0.5 W/cm2, and time was 5 minutes each session. Each participant was put in the most comfortable and relaxed position as a supine lying position, and the patient was asked to expose the incision site to avoid any restriction for receiving phonophoresis around the incisional site, REN 4 and REN 6. The incision margin was cleaned with alcohol or normal saline, the ultrasound unit's plug was inserted into the main current supply, and the treatment approach (phonophoresis application for bee venom gel) was prepared; each participant received a total amount of about 0.6 mg to 1 mg of BV gel each session for a total of 5 minutes.29 The participants in the control group (Group B) received only low-intensity pulsed ultrasound applied around the incisional site, REN 4 and REN 6 for 5 minutes, as in Group A, using only plain gel without BV gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Combination Product: bee venom gel phonophoresisreceived low-intensity pulsed ultrasound using bee venom (BV) gel for 5 minutes for each session, three times a week, for three consecutive weeks postoperative and received regular medical care. |
| group B | Sham comparator | Device: low intensity ultrasoundreceived low-intensity pulsed ultrasound using only plain gel without BV gel for 5 minutes for each session, three times a week, for three consecutive weeks postoperative and received regular medical care. |
Who may qualify
- Ages
- 28 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients ranged in age from 28 to 50 years old.
- They had not previously undertaken another physical therapy modality for pain
- Non-smokers
- Under their own prescribed medications described by their physicians.
Key exclusion criteria (5 listed)
- had non-mesh inguinal hernioplasty.
- suffered from open or infected wounds.
- had any systemic diseases that may interfere with the study's objectives such as using chemo or radiotherapy.
- had allergy to bee venom.
- had associated disorders, such as immunodeficiency, HIV, diabetes, or anemia.
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 |
|---|---|---|
| bee venom gel phonophoresisAlso: low intensity Ultrasound with bee venom gela noncontact low-frequency pulsed ultrasound delivered through Bee Venom previously prepared gel as topical application using an ultrasonic therapy instrument with frequency, 0.5-MHZ pulsed mode (applicator 1.9 cm2) applied around the incision site, Ren 4 and Ren 6. The movement was over the incision margins, Ren 4 and Ren 6 with a pulsed duty cycle of 40% (4 ms on, 6 ms off), and power density of 0.5 W/cm2, Before and after each patient exposure, the ultrasonic applicator's performance was tested on a regular basis, and each test included all essential acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of the field distribution. | Combination product | group A |
| low intensity ultrasounda noncontact low-frequency pulsed ultrasound delivered through plain gel only using an ultrasonic therapy instrument with frequency, 0.5-MHZ pulsed mode (applicator 1.9 cm2) applied around the incision site, Ren 4 and Ren 6. The movement was over the incision margins, Ren 4 and Ren 6 with a pulsed duty cycle of 40% (4 ms on, 6 ms off), and power density of 0.5 W/cm2, Before and after each patient exposure, the ultrasonic applicator's performance was tested on a regular basis, and each test included all essential acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of the field distribution. | Device | group B |
Primary outcome
Serum C-reactive protein (CRP)
Time frame: change in CRP calculated at post-3 weeks of treatment minus baseline.
blood sample analyzed at laboratory unit
Manual Goniometer
Time frame: change in ranges of motion calculated at post-3 weeks of treatment minus baseline.
A simple long-arm goniometer with a 360° scale marked in one-degree increments was used. A manual goniometer was used for assessment of hip flexion, extension, abduction, and adduction range of motion (ROM).
The visual analogue scale (VAS)
Time frame: change in VAS calculated at post-3 weeks of treatment minus baseline.
The visual analogue scale (VAS) is a 10-cm-long line with the ends labelled as the pain extremes (e.g., no pain to unbearable pain). Between "no pain" and "worst pain," patients were asked to mark the spot on the line that best described their pain experience. The operator then measured in millimetres the gap between zero and "no pain".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in bee venom or ulcer . we will share the results of this study within 1 year following publication
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. This study is not recruiting at the moment.
eman othman, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bee venom gel phonophoresis and low intensity ultrasound in people with Complications; C, Intestinal (Internal), run by Cairo 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: finished, as of the sponsor's last update on 18 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum C-reactive protein (CRP) (time frame: change in CRP calculated at post-3 weeks of treatment minus baseline.). The study lists 3 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 18 Mar 2022.