NCT05286463|Completed
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Sponsor study identifier
interventional
66
1 country
1
Study Start
March 2, 2021
Actual (reported)Primary Completion
February 5, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)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?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2021
Actual (reported)February 5, 2022
Actual (reported)February 28, 2022
Actual (reported)February 28, 2022
Actual (reported)March 18, 2022
Actual (reported)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.
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.
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.
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.
Faculty of Physical Therapy
Giza, 11432, Egypt
eman othman, professor
Cairo University
66 participants (actual enrollment reported by the registry).
First Submitted
February 28, 2022
First Posted
March 18, 2022
Study Start
March 2, 2021
Actual (reported)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.
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Primary Completion
February 5, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Last Updated
March 18, 2022
Record last verified: 2022-03
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
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Source: ClinicalTrials.gov.
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