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

NCT07578220 | Recruiting DMC

• 1 other identifier: 2025-KY-458-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The Bath Ankylosing Spondylitis Disease Activity Index

  Week 0，Week 2，Week 8

• The Bath Ankylosing Spondylitis Functional Index

  Week 0，Week 2，Week 4，Week 8

• Ankylosing Spondylitis Disease Activity Score based on C-reactive protein

  Week 0，Week 2，Week 4，Week 8

• The Bath Ankylosing Spondylitis Metrology Index

  Week 0，Week 2，Week 4，Week 8

• The Ankylosing Spondylitis Quality of Life Scale

  Week 0，Week 2，Week 4，Week 8

Study Arms (2)

the acupotomy intervention group

EXPERIMENTAL

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

the sham acupotomy intervention group

SHAM COMPARATOR

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

Interventions

Acupotomy PROCEDURE

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.

the acupotomy intervention group

Sham Acupotomy PROCEDURE

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.

the sham acupotomy intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Henan University of Chinese Medicine

Henan, Zhengzhou, 450002, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Yuqiao Zhang

CONTACT

+86 13661102043; 2378731115@qq.com

Study Design

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

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: December 2, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)