Application Effects of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery

NCT ID: NCT07340307

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-25
• Study Completion Date: 2026-10-24

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.

Conditions

Wrist-Ankle Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

wrist-ankle acupuncture

Intervention Type: DEVICE

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 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.

Group Type: EXPERIMENTAL

wrist-ankle acupuncture

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Putian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Putian University

Putian, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chenxing C Jian

Role: CONTACT

ptyyjcx@126.com

+8613959538950

Facility Contacts

Chenxing C Jian

Role: primary

ptyyjcx@126.com

+8613959538950

Other Identifiers

AHPutianU-015

Identifier Type: -

Identifier Source: org_study_id