Acupuncture Versus Transcutaneous Electrical Nerve Stimulation on Pain Post Upper Abdominal Surgeries

June 24, 2025 updated by: Samar Saad Nazim Mohamed, Cairo University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Samar Saad Nazim Mohamed, physical therapist
  • Phone Number: 01003097314
  • Email: samarrrsaad@gmail.com

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Recruiting
        • Mansoura international hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
This group includes 20 patients who will receive Acupuncture 4 weeks (3times/week) and medical treatment
Other: Acupuncture
Cholecystectomy 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.
Other: drugs
analgesics and nonsteroidal anti-inflammatory drugs
Active Comparator: Transcutaneous electrical nerve stimulation
This group includes 20 patients who will receive Transcutaneous electrical nerve stimulation 4 weeks (3times/week) and medical treatment
Other: drugs
analgesics and nonsteroidal anti-inflammatory drugs
Other: Transcutaneous electrical nerve stimulation
Patients 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of change of pressure pain threshold
Time Frame: At baseline and 4 weeks
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.
At baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

June 14, 2025

First Submitted That Met QC Criteria

June 24, 2025

First Posted (Estimated)

June 25, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Samar-005748

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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