NCT07238504

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

September 24, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

September 24, 2025

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximal pain intensity

    Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 means 'worst pain')

    Post-operative day 1

Secondary Outcomes (7)

  • Maximal and resting pain intensity

    Post-operative day 0, 2 to 7 and 14

  • Dosage of analgesics requirement

    Post-operative 2 weeks

  • Length of hospital stay

    Post-operative day 1

  • Functional recovery questionnaire

    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)

  • Adverse effect

    Post-operative 2 weeks

  • +2 more secondary outcomes

Study Arms (2)

Fully active acupuncture

EXPERIMENTAL
Procedure: Acupuncture

Minimum acupuncture stimulation

SHAM COMPARATOR
Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.

Also known as: Fully active acupuncture
Fully active acupuncture

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic grade III or IV hemorrhoids undergoing conventional hemorrhoidectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

September 24, 2025

First Posted

November 20, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share