Wrist-Ankle AcupunctureNCT07340307
Application Effects of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery
A study testing wrist-ankle acupuncture in people with Wrist-Ankle Acupuncture, run by The Affiliated Hospital of Putian University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wrist-Ankle Acupuncture
- What is being tested?
- wrist-ankle acupuncture
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2025to 24 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Putian University
Putian
Chenxing C Jian, +8613959538950, ptyyjcx@126.com
About this study
Official title: 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.
- Conditions
- Wrist-Ankle Acupuncture
- Being tested
- wrist-ankle acupuncture
- Keywords
- Wrist-Ankle Acupuncture, Analgesia, Pain Management, Perianal abscess, hemorrhoids, anal fistula
- Medical subject headings
- Agnosia, Hemorrhoids, Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wrist-ankle acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: wrist-ankle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the hospitalization period
Secondary outcomes (2)
Analgesic Medication Frequency
The frequency of use of postoperative analgesic medications, such as flurbiprofen, was recorded.
Measured: During the hospitalization period
Clinical Postoperative Urinary Retention (POUR) Score
The Clinical Postoperative Urinary Retention (POUR) scores of patients were observed and recorded at 24 hours after surgery.
Measured: 7days postoperativelyacupuncture administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start25 Oct 2025
- Primary completion24 Aug 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist-Ankle AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Putian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340307
- Sponsor's protocol ID
- AHPutianU-015
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07340307
- Acronym / sponsor ID
- AHPutianU-015
- Conditions
- Wrist-Ankle Acupuncture
- Keywords
- Wrist-Ankle Acupuncture, Analgesia, Pain Management, Perianal abscess, hemorrhoids, anal fistula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Putian UniversityUniversity, hospital or other
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 24 Aug 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spastic pain group | Experimental | Device: wrist-ankle acupunctureThe 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. |
| Acute incisional pain group | Experimental | Device: wrist-ankle acupunctureThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wrist-ankle acupuncturePatients 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. | Device | Acute incisional pain group, Spastic pain group |
Primary outcome
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.
2 secondary outcomes
Analgesic Medication Frequency
Time frame: During the hospitalization period
Clinical Postoperative Urinary Retention (POUR) Score
Time frame: 7days postoperativelyacupuncture administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wrist-ankle acupuncture in people with Wrist-Ankle Acupuncture, run by The Affiliated Hospital of Putian University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenxing C Jian (+8613959538950, ptyyjcx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: During the hospitalization period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.