Effect of Ultrasound-enhanced Bee Venom on Selected Post Inguinal Hernioplasty Complications

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?

Study Overview

• Status: Completed
• Conditions: Complications; C, Intestinal (Internal)
• Intervention / Treatment: Combination product: bee venom gel phonophoresis; Device: low intensity ultrasound

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11432
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria: Patients were excluded if they:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; 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.	Combination product: bee venom gel phonophoresis; 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.; Other Names: low intensity Ultrasound with bee venom gel
Sham Comparator: group B; 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.	Device: low intensity ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum C-reactive protein (CRP)	blood sample analyzed at laboratory unit	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).	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".	change in VAS calculated at post-3 weeks of treatment minus baseline.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Actual): February 5, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: phonophoresis, inguinal hernioplasty, bee venom
• Other Study ID Numbers: /012/002764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: within 1 year following publication
• IPD Sharing Access Criteria: the criteria will be assessed by the publication of the trial in an international journals.
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No