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

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.

Study Overview

• Status: Completed
• Conditions: Constipation - Functional
• Intervention / Treatment: Device: Warm Needling; Device: Electroacupuncture

Detailed Description

Background and Rationale Chronic functional constipation (FC) is a highly prevalent disorder that significantly diminishes quality of life and is frequently associated with psychological comorbidities such as anxiety and depression. Within the framework of Traditional Chinese Medicine (TCM), a prominent subtype is "Yang deficiency type" FC. Its pathophysiology is understood as a deficiency of Yang Qi, resulting in slowed metabolism and weakened motility of the large intestine. The acupoints Tianshu (ST25), the Front-Mu point of the Large Intestine, and Guanyuan (CV4), the Front-Mu point of the Small Intestine and a crucial point for nourishing Yuan Qi, are classically combined to warm Yang and regulate intestinal function. This trial investigates whether the combined thermal and stimulatory effects of warm needling at these points offer superior and more sustained clinical benefits compared to electroacupuncture alone.

Study Design and Methodology This is a single-center, parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio, conducted at the First Affiliated Hospital of Henan University of Chinese Medicine. A total of 60 participants diagnosed with Yang deficiency type chronic FC will be randomized into either an experimental group (warm needling) or a control group (electroacupuncture).

Intervention Details Experimental Group (Warm Needling): After standard disinfection, single-use sterile stainless steel needles (0.25×40mm) will be inserted perpendicularly at Tianshu (ST25) and Guanyuan (CV4) to achieve deqi (the characteristic needling sensation). Subsequently, a prepared moxa stick (approx. 2cm in diameter, 3cm in length) will be attached to the handle of each needle and ignited. The heat is conducted down the needle to the deeper tissues. Needles will be retained for 30 minutes with careful monitoring to prevent burns.

Control Group (Electroacupuncture): Needle insertion and deqi technique will be identical to the experimental group. Needle handles will then be connected to an electroacupuncture device (Hwato SDZ-V series) delivering a dense-sparse wave (2/15 Hz) at an intensity sufficient to produce mild, non-painful muscle twitching. Needles will be retained for 30 minutes.

Both groups will receive treatment every other day, three times weekly, for a total course of four weeks.

Therapeutic Rationale Tianshu (ST25) is strategically selected for its direct regulatory effect on large intestine function. Guanyuan (CV4) is chosen for its powerful action in warming and tonifying Yang Qi. The warm needling technique synergistically combines the meridian-regulating effect of acupuncture with the deep, penetrating warmth of moxibustion. This is hypothesized to enhance local circulation, modulate neuroendocrine pathways involved in the brain-gut axis, and provide a more potent Yang-tonifying effect than electroacupuncture alone, potentially leading to more durable improvements in bowel function.

Follow-up and Outcome Assessment To evaluate the sustainability of the treatment effect, all participants will undergo a follow-up assessment six months after the completion of the 4-week treatment course. No study-related interventions will be provided during this period. The primary outcome is the change from baseline in the Constipation Severity Score (CSS) at week 4 and month 6. Secondary outcomes include changes in TCM syndrome score, Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and Patient Assessment of Constipation Quality of Life (PAC-QOL) scale. Outcome assessors and statisticians will be blinded to group allocation. Analysis will be conducted on an intention-to-treat basis.

Significance This study aims to provide rigorous clinical evidence on the efficacy of warm needling for a well-defined TCM condition. By including a 6-month follow-up, it will offer valuable insights into the durability of the therapeutic response, informing clinical practice and guiding future research on non-pharmacological interventions for chronic functional constipation.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000,
      • the First Affiliated Hospital of Henan University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

No other treatments received before inclusion

Exclusion of organic digestive system lesions confirmed by colonoscopy or other appropriate examinations

Voluntary participation with signed informed consent

Exclusion Criteria:

Not meeting the inclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warm Needling at Tianshu and Guanyuan; 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; 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.; Other Names: Warming Acupuncture
Active Comparator: Electroacupuncture at Tianshu and Guanyuan; 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; 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.; Other Names: Electrical Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TCM syndrome score	A TCM syndrome scoring scale was developed based on the 'Consensus Opinion on the Diagnosis and Treatment of Functional Constipation Using Integrated Traditional Chinese and Western Medicine (2017)'. Primary symptoms were scored 0, 2, 4, 6; secondary symptoms 0, 1, 2, 3.	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. Higher scores indicate more severe anxiety.	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. Higher scores indicate more severe depression.	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. Higher scores indicate worse quality of life.	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, categorized as cured, significantly effective, effective, or ineffective according to the consensus. Total effective rate = (cured+significantly effective+effective)/total×100%.	Clinical efficacy at week 4

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Traditional Chinese Medicine; Warm Needling; Yang Deficiency; Tianshu Acupoint; Guanyuan Acupoint
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Yang Deficiency; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Combined Modality Therapy; Anesthesia; Analgesia; Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Electroacupuncture
• Other Study ID Numbers: 2022HL-428-01; 2024ZXZX1102 (Other Grant/Funding Number: Yongkang An); 2022JDZX010 (Other Grant/Funding Number: Xiang'an Zhang)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No