A Clinical Study on Warm Needling Moxibustion at Tianshu and Guanyuan Acupoints

NCT07483229 | Completed

• 3 other identifiers: 2022HL-428-012024ZXZX11022022JDZX010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of two different acupuncture techniques for treating a specific type of chronic constipation, known in Traditional Chinese Medicine as "Yang deficiency type" chronic functional constipation. Chronic functional constipation is a common condition characterized by difficult or infrequent bowel movements. The "Yang deficiency" pattern is believed to be caused by a lack of functional energy (Qi) and warmth in the body, leading to sluggish bowel motility. This study will enroll 60 eligible participants who will be randomly assigned to one of two groups: Experimental Group: Participants will receive "warm needling" therapy. This involves inserting acupuncture needles at specific points (Tianshu and Guanyuan) and then burning a small moxa stick on the needle handle to generate heat. Control Group: Participants will receive electroacupuncture at the same acupoints. This involves attaching the needles to a device that delivers a mild electric current. Both groups will receive treatment every other day, three times a week, for a total of four weeks. We will assess their constipation symptoms, anxiety and depression levels, and quality of life using standardized questionnaires immediately after the 4-week treatment and again 6 months later. The goal is to see which method provides better relief, both in the short term and long term.

Conditions

Constipation - Functional

Keywords

Yang Deficiency; Warm Needling; Tianshu Acupoint; Guanyuan Acupoint; Traditional Chinese Medicine; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Constipation Severity Score (CSS)

  Change from baseline in Constipation Severity Score (CSS) at week 4 and month 6. CSS (Cleveland Constipation Scoring System) assesses constipation severity; higher scores indicate greater severity.

  Change from baseline in Constipation Severity Score (CSS) at week 4 and month 6.

Secondary Outcomes (5)

• TCM syndrome score

  Change from baseline in TCM syndrome score at week 4 and month 6.

• Self-Rating Anxiety Scale (SAS) score

  Change from baseline in Self-Rating Anxiety Scale (SAS) score at week 4 and month 6.

• Self-Rating Depression Scale (SDS) score

  Change from baseline in Self-Rating Depression Scale (SDS) score at week 4 and month 6

• Patient Assessment of Constipation Quality of Life (PAC-QOL) scale

  Change from baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) scale at week 4 and month 6

• Clinical efficacy

  Clinical efficacy at week 4

Study Arms (2)

Warm Needling at Tianshu and Guanyuan

EXPERIMENTAL

Participants receive warm needling therapy at Tianshu (ST25) and Guanyuan (CV4) acupoints. After achieving deqi (needling sensation) with standard acupuncture needles (0.25×40mm), a moxa stick (2cm diameter, 3cm length) is ignited and attached to the needle handle, providing combined thermal and acupoint stimulation for 30 minutes per session. Treatment is administered every other day, three times weekly, for a total of four weeks.

Device: Warm Needling

Electroacupuncture at Tianshu and Guanyuan

ACTIVE COMPARATOR

Participants receive electroacupuncture at Tianshu (ST25) and Guanyuan (CV4) acupoints. After achieving deqi with standard acupuncture needles (0.25×40mm), needle handles are connected to an electroacupuncture device (Hwato SDZ-V series) delivering a dense-sparse wave (2/15 Hz) at an intensity sufficient to produce mild muscle twitching. Needles are retained for 30 minutes per session. Treatment is administered every other day, three times weekly, for a total of four weeks.

Device: Electroacupuncture

Interventions

Warm Needling DEVICE

Warm Needling： After routine disinfection with 75% alcohol, disposable sterile stainless steel acupuncture needles (0.25×40 mm) are inserted perpendicularly at Tianshu (ST25) to a depth of approximately 25 mm and at Guanyuan (CV4) to approximately 20 mm. After achieving deqi (local soreness, distension, or radiation to ipsilateral abdomen or groin), a moxa stick (diameter 2 cm, length 3 cm) is ignited and attached to the needle handle with the lit end facing upward. Needles are retained for 30 minutes per session, with care taken to avoid skin burns. Treatment is administered every other day, three times weekly, for a total of four weeks.

Also known as: Warming Acupuncture

Warm Needling at Tianshu and Guanyuan

Electroacupuncture DEVICE

Electroacupuncture：After routine disinfection with 75% alcohol, disposable sterile stainless steel acupuncture needles (0.25×40 mm) are inserted perpendicularly at Tianshu (ST25) to a depth of approximately 25 mm and at Guanyuan (CV4) to approximately 20 mm. After achieving deqi (local soreness, distension, or radiation to ipsilateral abdomen or groin), a balanced tonifying and reducing technique is used. The needle handles are connected to an electroacupuncture device (Hwato SDZ-V series electronic needle therapy instrument) with a dense-sparse wave (2/15 Hz) at an intensity sufficient to produce mild muscle twitching. Needles are retained for 30 minutes per session. Treatment is administered every other day, three times weekly, for a total of four weeks.

Also known as: Electrical Acupuncture

Electroacupuncture at Tianshu and Guanyuan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years, either sex
• Meeting the Rome IV diagnostic criteria for functional constipation
• Meeting the Traditional Chinese Medicine diagnostic criteria for Yang deficiency type constipation
• Voluntary participation with signed informed consent

You may not qualify if:

• Pregnant or lactating women
• Serious cardiovascular or cerebrovascular diseases
• Inability to receive abdominal acupuncture due to skin diseases or other local conditions
• Participation in other clinical trials within the past 3 months

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000,, China

Location

MeSH Terms

Conditions

Yang Deficiency

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Model Details: Parallel-group, superiority randomized controlled trial with 1:1 allocation. Participants are randomized to receive either warm needling or electroacupuncture at Tianshu (ST25) and Guanyuan (CV4). Both groups follow the same treatment schedule: every other day, three times weekly for four weeks. Outcome assessors and statisticians are blinded to group allocation; participants and acupuncturists are not blinded due to the nature of the interventions.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 19, 2026
• Study Start: August 1, 2022
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)