Clinical Trial Study on the Improved New Method of Acupotomy for AS

Clinical Trial Study on the Improved New Method of Acupotomy for Ankylosing Spondylitis

This study employs a randomized controlled trial methodology to systematically evaluate the efficacy and safety of a modified acupotomy technique in the treatment of ankylosing spondylitis. Through ultrasound-guided localization, the operative sites are assessed to clarify the improvement effect of the modified acupotomy on disease activity in AS patients. The aim is to enhance the clinical outcomes of AS, provide evidence-based medical support for acupotomy treatment of AS, and improve the diagnosis and treatment standards for the condition.

Study Overview

• Status: Recruiting
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Procedure: Sham Acupotomy; Procedure: Acupotomy

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

Contacts and Locations

• Study Contact: Name: Yuqiao Zhang; Phone Number: +86 13661102043; Email: 2378731115@qq.com

Study Locations

• China
  • Zhengzhou
    • Henan, Zhengzhou, China, 450002
      • Recruiting
      • The Second Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: Zhou Zipeng; Phone Number: 13613863247; Email: 13613863247@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Meeting the 1984 revised New York criteria or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis
2. Age 18-75 years
3. BASDAI ≥4
4. Signed informed consent form

Exclusion Criteria:

1. Presence of autoimmune diseases other than the studied condition
2. Complete spinal ankylosis or spinal deformity
3. Pregnant or lactating women
4. Comorbid severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, malignant tumors, or coagulation disorders
5. Patients unable to comply with data collection due to mental, linguistic, or similar factors
6. Patients with psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the acupotomy intervention group; All subjects were enrolled at week 0 and, after completing baseline assessments, received acupotomy treatment once per week for a total of four sessions over the initial three-week period. The core intervention for theacupotomy intervention group involved ultrasound-guided precise release: first, the target vertebra with the most significant lesions was identified through palpation and ultrasound imaging, after which the acupotomy was accurately guided in real-time via ultrasound to the interspinous points (located at the interspinous ligaments) and paraspinal points (located at the intertransverse ligaments) of the target vertebra and adjacent vertebrae for release.	Procedure: Acupotomy; All subjects were enrolled at week 0 and, after completing baseline assessments, received acupotomy treatment once per week for a total of four sessions over the initial three-week period. The core intervention for the treatment group (acupotomy group) involved ultrasound-guided precise release: first, the target vertebra with the most significant lesions was identified through palpation and ultrasound imaging, after which the acupotomy was accurately guided in real-time via ultrasound to the interspinous points (located at the interspinous ligaments) and paraspinal points (located at the intertransverse ligaments) of the target vertebra and adjacent vertebrae for release.
Sham Comparator: the sham acupotomy intervention group; The sham acupotomy intervention group strictly replicated all preliminary procedures of the treatment group, including exploration, ultrasound localization, and local anesthesia. However, the acupotomy needle only pierced the epidermis without performing any release operations in the deeper tissues, thereby maintaining blinding and assessing the specific effect of the acupotomy therapy.	Procedure: Sham Acupotomy; The control group (sham acupotomy group) strictly replicated all preliminary procedures of the treatment group, including exploration, ultrasound localization, and local anesthesia. However, the acupotomy needle only pierced the epidermis without performing any release operations in the deeper tissues, thereby maintaining blinding and assessing the specific effect of the acupotomy therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bath Ankylosing Spondylitis Disease Activity Index	Based on the patient's symptoms over the past week, an assessment is conducted through six questions. The first five questions are scored using a Visual Analog Scale (VAS, 0-10 points). The calculation formula is generally expressed as: BASDAI = 0.2 × (A + B + C + D + (E + F)/2) Where: A represents the degree of fatigue/tiredness; B represents the degree of pain in the neck, back, or hips; C represents the degree of pain/swelling in other joints; D represents the level of discomfort from bodily tenderness or pressure pain; E represents the severity of morning stiffness; F represents the duration of morning stiffness (converted to a 0-10 score). BASDAI ≥4 indicates high disease activity, while a score <4 suggests lower disease activity.	Week 0，Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Bath Ankylosing Spondylitis Disease Activity Index	Based on the patient's symptoms over the past week, an assessment is conducted through six questions. The first five questions are scored using a Visual Analog Scale (VAS, 0-10 points). The calculation formula is generally expressed as: BASDAI = 0.2 × (A + B + C + D + (E + F)/2) Where: A represents the degree of fatigue/tiredness; B represents the degree of pain in the neck, back, or hips; C represents the degree of pain/swelling in other joints; D represents the level of discomfort from bodily tenderness or pressure pain; E represents the severity of morning stiffness; F represents the duration of morning stiffness (converted to a 0-10 score). BASDAI ≥4 indicates high disease activity, while a score <4 suggests lower disease activity.	Week 0，Week 2，Week 8
The Bath Ankylosing Spondylitis Functional Index	The Bath Ankylosing Spondylitis Functional Index (BASFI) is a 10-item instrument used to measure functional limitation in patients with ankylosing spondylitis. Each item is scored on a 0 to 10 visual analog scale, where 0 indicates easy and 10 indicates impossible. The total score is calculated as the mean of the 10 item scores and ranges from 0 to 10. Higher scores indicate worse functional status.	Week 0，Week 2，Week 4，Week 8
Ankylosing Spondylitis Disease Activity Score based on C-reactive protein	The Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) is a composite index used to measure disease activity in participants with ankylosing spondylitis. It combines patient-reported items and C-reactive protein (CRP) levels into a single score. The minimum score is 0, with lower scores indicating lower disease activity and higher scores indicating worse disease activity. There is no fixed maximum value because the upper end of the scale depends on the CRP level. ASDAS-CRP disease activity states are defined as inactive disease (<1.3), moderate disease activity (1.3 to <2.1), high disease activity (2.1 to ≤3.5), and very high disease activity (>3.5). Clinically important improvement is defined as a decrease of at least 1.1 units, and major improvement is defined as a decrease of at least 2.0 units.	Week 0，Week 2，Week 4，Week 8
The Bath Ankylosing Spondylitis Metrology Index	The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an instrument used to measure axial skeletal mobility in participants with ankylosing spondylitis. The total score ranges from 0 to 10. Lower scores indicate better spinal and hip mobility, while higher scores indicate greater limitation of movement and worse axial mobility.	Week 0，Week 2，Week 4，Week 8
The Ankylosing Spondylitis Quality of Life Scale	The Ankylosing Spondylitis Quality of Life Scale (ASQoL) is a patient-reported instrument used to measure the impact of ankylosing spondylitis on health-related quality of life. The total score ranges from 0 to 18. Lower scores indicate better quality of life, while higher scores indicate worse quality of life.	Week 0，Week 2，Week 4，Week 8
Pain Score on the Visual Analogue Scale	Pain due to ankylosing spondylitis measured on a 0 to 10 Visual Analogue Scale (VAS) over the past week, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain.	Week 0，Week 2，Week 4，Week 8
Use of Rescue Medication	Use of rescue medication during the study period, including medication type, dose, frequency, duration, and changes over time, prospectively recorded based on participant-reported and recorded medication use.	Week 0，Week 2，Week 4，Week 8

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Spondylitis, Ankylosing; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: 2025-KY-458-4

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