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

NCT07036393 | Recruiting

• 1 other identifier: Samar-005748
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Transcutaneous Electrical Nerve Stimulation; Pain; Upper Abdominal Surgery

Outcome Measures

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.

  At baseline and 4 weeks

Secondary Outcomes (1)

• assessment of change of pressure pain threshold

  At baseline and 4 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

This group includes 20 patients who will receive Acupuncture 4 weeks (3times/week) and medical treatment

Other: Acupuncture; Other: drugs

Transcutaneous electrical nerve stimulation

ACTIVE COMPARATOR

This group includes 20 patients who will receive Transcutaneous electrical nerve stimulation 4 weeks (3times/week) and medical treatment

Other: Transcutaneous electrical nerve stimulation; Other: drugs

Interventions

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.

Acupuncture

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

Transcutaneous electrical nerve stimulation

drugs OTHER

analgesics and nonsteroidal anti-inflammatory drugs

Acupuncture; Transcutaneous electrical nerve stimulation

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mansoura international hospital

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Samar Saad Nazim Mohamed, physical therapist

CONTACT

01003097314; samarrrsaad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 25, 2025
• Study Start: April 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

EG (1)