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NCT Number: NCT07036393

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

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.

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Key information

Conditions

Acupuncture Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Transcutaneous Electrical Nerve Stimulation Upper Abdominal Surgery

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura international hospital

Al Mansurah, Egypt

Location status: Recruiting

Location contact

Samar Saad Nazim Mohamed, physical therapist

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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.

Transcutaneous Electrical Nerve Stimulation

Other

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

drugs

Other

analgesics and nonsteroidal anti-inflammatory drugs

Primary outcomes

  1. 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

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samar Saad Nazim Mohamed, physical therapist

CONTACT

[email protected]

01003097314

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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