Acupuncture Versus Transcutaneous Electrical Nerve Stimulation on Pain Post Upper Abdominal Surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- assessment of change of postoperative quality of recovery
Study Overview
Brief Summary
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.
Detailed Description
Postoperative pain is caused by tissue damage from surgical incisions, triggering acute nociceptive activity in sensory nerve endings. Pain sensations reach the brain through dorsal horn, where it is recognized and interpreted. Management modalities include pharmacologic and non-pharmacologic methods. This study aims to provide a guideline on the effect of acupuncture and transcutaneous electrical nerve stimulation on pain reduction after upper abdominal surgeries.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Patients with good compliance and fit for treatment.
- •This study will be applied on upper abdominal surgeries [laparoscopic cholecystectomy, Gastrectomy].
- •Physical therapy will be used for up to 48 hours after surgery or until the time of discharge.
Exclusion Criteria
- •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.
- •Patients with metal or electronic implants.
- •Patients with autoimmune disease.
- •Pregnancy, postpartum period, breastfeeding.
- •Patients with recent injury in the treatment area
Arms & Interventions
Acupuncture
This group includes 20 patients who will receive Acupuncture 4 weeks (3times/week) and medical treatment
Intervention: Acupuncture (Other)
Acupuncture
This group includes 20 patients who will receive Acupuncture 4 weeks (3times/week) and medical treatment
Intervention: drugs (Other)
Transcutaneous electrical nerve stimulation
This group includes 20 patients who will receive Transcutaneous electrical nerve stimulation 4 weeks (3times/week) and medical treatment
Intervention: Transcutaneous electrical nerve stimulation (Other)
Transcutaneous electrical nerve stimulation
This group includes 20 patients who will receive Transcutaneous electrical nerve stimulation 4 weeks (3times/week) and medical treatment
Intervention: drugs (Other)
Outcomes
Primary Outcomes
assessment of change of postoperative quality of recovery
Time Frame: At baseline and 4 weeks
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.
Secondary Outcomes
- assessment of change of pressure pain threshold(At baseline and 4 weeks)
Investigators
Samar Saad Nazim Mohamed
principal investigator
Cairo University