Acupuncture Versus Transcutaneous Electrical Nerve Stimulation on Pain Post Upper Abdominal Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorCairo University
About this trial
This study was done to:
* Determine the therapeutic efficacy of acupuncture as physical therapy approach in minimizing pain post upper abdominal surgeries. * Determine the therapeutic efficacy of transcutaneous electrical nerve stimulation in minimizing pain post upper abdominal surgeries. * Compare the efficacy and safety of Transcutaneous electrical nerve stimulation versus acupuncture in minimizing pain post upper abdominal surgeries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who will have pain after upper abdominal surgery.
Adult patients will be between 20 and 45 years of age.
Both sexes will be included.
Patients have no contraindications for acupuncture or transcutaneous electrical nerve stimulation.
Disqualifiers
Patients with other causes of pain other than that after upper abdominal surgery.
Patients who will have any contraindication for both therapies used.
Patients with cardiovascular disease, liver, or renal disease.
Patients with malignant tumors.
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Other interventionCholecystectomy involves a procedure where patients' spines are kept in position and skin around the acupoints is disinfected with 75% alcohol. Acupuncture treatment is given when patients return to units within 2 hours after surgery. The needles are inserted using disposable sterile needles and manipulated to induce a sense of "De qi" (soreness, numbness, distension, or heaviness). Gastrectomy involves daily acupuncture sessions for 5 consecutive days, starting on postoperative day 1. The needles are inserted perpendicular to the acupoints in the extremities to a depth of approximately 20 mm from the skin surface.
Transcutaneous electrical nerve stimulation
Other interventionPatients will receive a transcutaneous electrical nerve stimulation unit (ENNRAF) for up to 48 hours post-surgery, with instructions to self-titrate intensity for pain relief. Postoperative stimulation will be 20-40 milliampere and pulse width 5
drugs
Other interventionanalgesics and nonsteroidal anti-inflammatory drugs
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: AcupunctureExperimental treatment 2 interventions
Group B: Transcutaneous electrical nerve stimulationActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
assessment of change of postoperative quality of recovery
The Postoperative Quality of Recovery Scale is a verbal scale designed to assess the quality of recovery in six domains: physiology, nociceptive, emotional, activities of daily living, cognitive, and overall patient perspective. It measures systolic blood pressure, heart rate, temperature, respiratory rate, oxygen saturation, and airway control, aiming to assess physiologic safety and home readiness for day care surgery. It also assesses pain and nausea using a 1-5% Likert rating scale. Emotional domain measures feelings of anxiety and depression. Activities of daily living assess physical return to normality through daily activities, with scores ranging from 3 to 1. Cognitive domain measures orientation, verbal memory, executive functioning, attention, and concentration. Performance variability tolerance factors are applied to ensure participants are not included in subsequent analysis if baseline scores are equal to or less than the tolerance factor.
Time frame
At baseline and 4 weeksSecondary outcomes
1
assessment of change of pressure pain threshold
An algometer is a handheld device used for pressure tolerance testing, typically with a 1-cm2 pressure application surface and force readings in newtons or kilograms. It has a resolution of 0.2 newton, 250-newton capacity, and a 1000-Hz sampling rate. The device is designed to measure pains and track recovery/healing, and is tested for high reliability and validity compared to force plate readings.
Time frame
At baseline and 4 weeksSponsors and contacts
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Source ClinicalTrials.gov