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

Zhengzhou University

Status: Enrolling

Conditions: Ankylosing Spondylitis

Treatments: Procedure: Acupotomy; Procedure: Sham Acupotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07390929

2025YFC3508501

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meeting the revised New York Criteria (1984) or the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis (2009).
2. Aged 18 to 75 years old.
3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 points.
4. Having signed the informed consent form.

Exclusion criteria

1. Complicated with other autoimmune diseases except for the research disease.
2. Complete ankylosis or deformity of the spine.
3. Pregnant or lactating women.
4. Complicated with severe cardiovascular and cerebrovascular diseases, liver or kidney failure, malignant tumors, or coagulation disorders.
5. Patients whose data collection is affected by mental, language or other factors.
6. Patients with psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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.

Treatment:

Procedure: Acupotomy

Control Group

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham Acupotomy