AcupunctureNCT07036393
Acupuncture Versus Transcutaneous Electrical Nerve Stimulation on Pain Post Upper Abdominal Surgeries
A study testing Acupuncture, Transcutaneous electrical nerve stimulation and drugs in people with Acupuncture and Transcutaneous Electrical Nerve Stimulation, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Acupuncture, Transcutaneous Electrical Nerve Stimulation, Pain
- What is being tested?
- Acupuncture, Transcutaneous electrical nerve stimulation and drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura international hospital
Al Mansurah
Samar Saad Nazim Mohamed, physical therapist, samarrrsaad@gmail.com
About this study
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.
Read the 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.
- Being tested
- Acupuncture, Transcutaneous electrical nerve stimulation, drugs
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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 stimulationOther
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
drugsOther
analgesics and nonsteroidal anti-inflammatory drugs
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | This group includes 20 patients who will receive Acupuncture 4 weeks (3times/week) and medical treatment Receives: 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 Receives: Other: Transcutaneous electrical nerve stimulation; Other: drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 4 weeks
Secondary 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.
Measured: At baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 Apr 2025
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Saad Nazim Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036393
- Sponsor's protocol ID
- Samar-005748
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Versus Transcutaneous Electrical Nerve Stimulation on Pain Post Upper Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT07036393
- Acronym / sponsor ID
- Samar-005748
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture, Other: drugsThis group includes 20 patients who will receive Acupuncture 4 weeks (3times/week) and medical treatment |
| Transcutaneous electrical nerve stimulation | Active comparator | Other: Transcutaneous electrical nerve stimulation, Other: drugsThis group includes 20 patients who will receive Transcutaneous electrical nerve stimulation 4 weeks (3times/week) and medical treatment |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureCholecystectomy 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 | Acupuncture |
| Transcutaneous electrical nerve stimulationPatients 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 | Other | Transcutaneous electrical nerve stimulation |
| drugsanalgesics and nonsteroidal anti-inflammatory drugs | Other | Acupuncture, Transcutaneous electrical nerve stimulation |
Primary outcome
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.
1 secondary outcome
assessment of change of pressure pain threshold
Time frame: At baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, Transcutaneous electrical nerve stimulation and drugs in people with Acupuncture and Transcutaneous Electrical Nerve Stimulation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Saad Nazim Mohamed, physical therapist (01003097314, samarrrsaad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of postoperative quality of recovery (time frame: At baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.