- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07340307
Application Effects of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery
January 13, 2026 updated by: The Affiliated Hospital of Putian University
Application of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery: A Prospective Cohort Study
This study is a prospective clinical observation designed to evaluate the analgesic effect of wrist-ankle acupuncture in patients with different types of pain after perianal surgery, as well as its applicability.
A total of 60 eligible postoperative patients were enrolled, with inclusion criteria including age 18-75 years, postoperative Visual Analog Scale (VAS) score ≥4, clear consciousness, and signed informed consent.
Exclusion criteria included pregnancy, history of needle fainting, skin lesions at the wrist or ankle, severe systemic diseases, inability to cooperate with follow-up, or participation in other clinical trials.
Patients were divided into two groups according to the nature of pain: Group A (sphincter spasm pain, n=30) and Group B (acute incisional pain, n=30).
All patients received routine postoperative care (including intravenous flurbiprofen infusion, traditional Chinese medicine soaking, and pain education), and wrist-ankle acupuncture was administered when pain intensity (Verbal Rating Scale, VRS) reached ≥4.
The acupuncture method involved superficial subcutaneous insertion in zones 1 and 6 of both lower limbs using disposable sterile needles (0.25 mm × 25 mm).
Needles were retained for 0.5-1 hour, once daily, with the treatment course adjusted based on symptom relief.
If the VAS score remained ≥4 at 30 minutes post-treatment, adjunctive analgesic medication was administered as prescribed.
Observation indicators included postoperative VRS scores, reduction in VAS scores at 5 and 30 minutes after wrist-ankle acupuncture treatment, frequency of analgesic medication use within the first 3 postoperative days, and the Clinical Postoperative Urinary Retention (POUR) score at 24 hours post-surgery.
By comparing data between the two groups, the analgesic effect of wrist-ankle acupuncture was analyzed, and the influence of postoperative pain on the occurrence of urinary retention was explored.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
58
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
- Name: Chenxing C Jian
- Phone Number: +8613959538950
- Email: ptyyjcx@126.com
Study Locations
-
-
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Putian, China
- Recruiting
- Affiliated Hospital of Putian University
-
Contact:
- Chenxing C Jian
- Phone Number: +8613959538950
- Email: ptyyjcx@126.com
-
-
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:
- Aged between 18 and 75 years;
- Patients who underwent perianal surgery;
- Visual Analog Scale (VAS) score ≥4;
- Clear consciousness with the ability to articulate their sensations;
- Voluntary participation with signed informed consent.
Exclusion Criteria:
- Pregnant or lactating patients;
- Patients with a history of needle fainting or needle phobia;
- Patients with incomplete skin integrity at the wrist or ankle;
- Patients with comorbid systemic diseases, such as cardiac insufficiency or coagulation disorders;
- Patients unable to cooperate with follow-up;
- Patients currently participating in other clinical trials that may influence the outcomes of this study.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spastic pain group
The pain in this group of patients was characterized as sphincter spasm pain.
Postoperatively, patients received routine care and were administered wrist-ankle acupuncture when their pain score (VRS) reached ≥4 points (performed at standardized zones 1 and 6 of both lower limbs, once daily, with treatment duration adjusted based on symptom response).
If the pain score (VAS) remained ≥4 points 30 minutes after treatment, analgesic medication was additionally administered.
|
Patients received routine postoperative care, including intravenous infusion of flurbiprofen (50 mg, twice daily), herbal sitz baths, and pain management education.
When a patient's Verbal Rating Scale (VRS) score reached ≥4 points, Wrist-Ankle Acupuncture therapy was administered.
The procedure involved superficial subcutaneous insertion of disposable sterile needles (0.25 mm × 25 mm) at zones 1 and 6 of both lower limbs.
The needle body was inserted subcutaneously, leaving approximately 1-2 mm exposed externally, with the aim of avoiding the induction of soreness, numbness, distension, or pain.
Needles were retained for 0.5-1 hour, with treatment administered once daily.
The treatment course was adjusted based on the degree of symptom relief.
If the Visual Analog Scale (VAS) score remained ≥4 points 30 minutes after initiating Wrist-Ankle Acupuncture treatment, analgesic medication was administered as prescribed.
|
|
Experimental: Acute incisional pain group
The pain in this group of patients was characterized as acute incisional pain.
Postoperatively, patients received routine care and were administered wrist-ankle acupuncture when their pain score (VRS) reached ≥4 points.
The procedure was performed at standardized zones 1 and 6 of both lower limbs, once daily, with the treatment duration adjusted according to symptom response.
If the pain score (VAS) remained ≥4 points 30 minutes after treatment, analgesic medication was additionally administered.
|
Patients received routine postoperative care, including intravenous infusion of flurbiprofen (50 mg, twice daily), herbal sitz baths, and pain management education.
When a patient's Verbal Rating Scale (VRS) score reached ≥4 points, Wrist-Ankle Acupuncture therapy was administered.
The procedure involved superficial subcutaneous insertion of disposable sterile needles (0.25 mm × 25 mm) at zones 1 and 6 of both lower limbs.
The needle body was inserted subcutaneously, leaving approximately 1-2 mm exposed externally, with the aim of avoiding the induction of soreness, numbness, distension, or pain.
Needles were retained for 0.5-1 hour, with treatment administered once daily.
The treatment course was adjusted based on the degree of symptom relief.
If the Visual Analog Scale (VAS) score remained ≥4 points 30 minutes after initiating Wrist-Ankle Acupuncture treatment, analgesic medication was administered as prescribed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity
Time Frame: During the hospitalization period
|
Pain assessment was conducted using the Visual Analog Scale (VAS).
A 10-cm horizontal line was drawn on paper, with one end marked as "0" indicating "no pain" and the opposite end marked as "10" indicating "severe pain."
The intermediate sections represented varying degrees of pain intensity.
Patients were instructed to mark a point on the line based on their subjective perception of pain.
Assessments were performed at 24 hours postoperatively, as well as at 5 minutes and 30 minutes after the administration of wrist-ankle acupuncture therapy.
The reduction in Visual Analogue Scale(VAS) scores was recorded accordingly.
|
During the hospitalization period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analgesic Medication Frequency
Time Frame: During the hospitalization period
|
The frequency of use of postoperative analgesic medications, such as flurbiprofen, was recorded.
|
During the hospitalization period
|
|
Clinical Postoperative Urinary Retention (POUR) Score
Time Frame: 7days postoperativelyacupuncture administration.
|
The Clinical Postoperative Urinary Retention (POUR) scores of patients were observed and recorded at 24 hours after surgery.
|
7days postoperativelyacupuncture administration.
|
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 (Actual)
October 25, 2025
Primary Completion (Estimated)
August 24, 2026
Study Completion (Estimated)
October 24, 2026
Study Registration Dates
First Submitted
January 6, 2026
First Submitted That Met QC Criteria
January 6, 2026
First Posted (Estimated)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Neurobehavioral Manifestations
- Rectal Diseases
- Perceptual Disorders
- Digestive System Fistula
- Fistula
- Intestinal Fistula
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Agnosia
- Hemorrhoids
- Rectal Fistula
Other Study ID Numbers
- AHPutianU-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.
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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