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

NCT05286463 | Completed

• 1 other identifier: /012/002764
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 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?

Conditions

Complications; C, Intestinal (Internal)

Keywords

phonophoresis, inguinal hernioplasty, bee venom

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

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.

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.

Device: low intensity ultrasound

Interventions

bee venom gel phonophoresis COMBINATION_PRODUCT

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.

Also known as: low intensity Ultrasound with bee venom gel

group A

low intensity ultrasound DEVICE

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.

group B

Eligibility Criteria

• Age: 28 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

Location

Study Officials

• eman othman, professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 18, 2022
• Study Start: March 2, 2021
• Primary Completion: February 5, 2022
• Study Completion: February 28, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: within 1 year following publication
• Access Criteria: the criteria will be assessed by the publication of the trial in an international journals.

Locations

EG (1)