Acupuncture for Post-hemorrhoidectomy Pain Control

November 24, 2025 updated by: Pak Chiu WONG, The University of Hong Kong

Acupuncture for Post-hemorrhoidectomy Pain Control With Acute Anti-inflammatory Effects: A Randomized Controlled Trial

The goal of this clinical trial is to learn if acupuncture improves pain control after hemorrhoidectomy in patients with symptomatic hemorrhoids. It will also learn about the safety of using acupuncture in surgical patients. The main questions it aims to answer are:

Does acupuncture lower the maximal pain intensity after hemorrhoidectomy? Does acupuncture reduce analgesics requirement, length of hospital stay and quality of recovery?

Researchers will compare fully active acupuncture to a sham treatment (a look-alike procedure with minimum acupuncture stimulation) to see if active acupuncture works to improve pain control.

Participants will:

Receive acupuncture treatment for 7 times over first 5 days after surgery. Visit the clinic once 2 weeks after surgery for checkups and tests. Keep a diary of their symptoms and the number of times they take pain-killers.

Study Overview

Status

Not yet recruiting

Study Type

Interventional

Enrollment (Estimated)

100

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

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic grade III or IV hemorrhoids undergoing conventional hemorrhoidectomy

Exclusion Criteria:

  1. Patients scheduled for stapled hemorrhoidopexy
  2. Concomitant surgery other than conventional hemorrhoidectomy
  3. Bleeding tendency, thrombocytopenia (platelet count < 100 x 10^9/L)
  4. Immunocompromised status or use of chemotherapy
  5. Active dermatitis
  6. Patients with pacemaker or automated implantable cardioverter-defibrillator
  7. Pregnant patients
  8. Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including cyclooxygenase-2 inhibitors
  9. History of chronic pain (duration for 3 months or more)
  10. Daily use of strong opioids (e.g. morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine)
  11. Alcohol or drug abuse
  12. Psychiatric illness
  13. Impaired renal function (preoperative serum creatinine level > 120µmol/L)
  14. Recent acupuncture treatment for other medical conditions

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fully active acupuncture
Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.
Other Names:
  • Fully active acupuncture
Minimal electrical stimulation to 1 local acupoint and 2 distant acupoints
Other Names:
  • Minimum acupuncture stimulation
Sham Comparator: Minimum acupuncture stimulation
Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.
Other Names:
  • Fully active acupuncture
Minimal electrical stimulation to 1 local acupoint and 2 distant acupoints
Other Names:
  • Minimum acupuncture stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal pain intensity
Time Frame: Post-operative day 1
Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 means 'worst pain')
Post-operative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal and resting pain intensity
Time Frame: Post-operative day 0, 2 to 7 and 14
Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 mean 'worst pain')
Post-operative day 0, 2 to 7 and 14
Dosage of analgesics requirement
Time Frame: Post-operative 2 weeks
Dosage of paracetamol, tramadol and celecoxib tablets taken per day over the first post-operative 2 weeks
Post-operative 2 weeks
Length of hospital stay
Time Frame: Post-operative day 1
Post-operative day 1
Adverse effect
Time Frame: Post-operative 2 weeks
Effect from analgesics and acupuncture
Post-operative 2 weeks
Quality of recovery (QoR)
Time Frame: Post-operative day 1
QoR-15 questionnaire, which includes 15 questions scoring at a 10-point scale. Minimum at 0 means worst outcome and maximum at 10 means best outcome.
Post-operative day 1
Serum C-reactive protein level
Time Frame: Post-operative day 0 and 1
Post-operative day 0 and 1
Functional recovery questionnaire
Time Frame: Post-operative 1 week (time to first bowel motion, time to first urination and time to return to work, counted from the day of operation)
Post-operative 1 week (time to first bowel motion, time to first urination and time to return to work, counted from the day of operation)

Collaborators and Investigators

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

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 (Estimated)

March 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Estimated)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • UW 25-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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