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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chenxing C Jian
  • Phone Number: +8613959538950
  • Email: ptyyjcx@126.com

Study Locations

  • China
      • Putian, China
        • Recruiting
        • Affiliated Hospital of Putian University
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: wrist-ankle acupuncture
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.
Device: wrist-ankle acupuncture
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Hospital of Putian University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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