NCT07340307

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
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 Progress54%
Oct 2025Oct 2026

Study Start

First participant enrolled

October 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 6, 2026

Last Update Submit

January 13, 2026

Conditions

Keywords

Wrist-Ankle AcupunctureAnalgesiaPain ManagementPerianal abscesshemorrhoidsanal fistula

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity

    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 Outcomes (2)

  • Analgesic Medication Frequency

    During the hospitalization period

  • Clinical Postoperative Urinary Retention (POUR) Score

    7days postoperativelyacupuncture administration.

Study Arms (2)

Spastic pain group

EXPERIMENTAL

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

Acute incisional pain group

EXPERIMENTAL

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

Interventions

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.

Acute incisional pain groupSpastic pain group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Putian University

Putian, China

RECRUITING

MeSH Terms

Conditions

AgnosiaHemorrhoidsRectal Fistula

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesIntestinal FistulaDigestive System FistulaFistulaPathological Conditions, Anatomical

Central Study Contacts

Chenxing C Jian

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

October 25, 2025

Primary Completion (Estimated)

August 24, 2026

Study Completion (Estimated)

October 24, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations