Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07578220

A Randomized Trial of Ultrasound-Guided 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Henan University of Chinese Medicine

Henan, Zhengzhou, 450002, China

Location status: Recruiting

Location contact

Zhou Zipeng

CONTACT

[email protected]

13613863247

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meeting the 1984 revised New York criteria or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis.
  • Aged 18-75 years.
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAl) score ≥4.
  • Provision of written informed consent.

Exclusion criteria

  • Presence of other autoimmune or inflammatory rheumatic diseases that may affect outcome assessment, including psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis;
  • Complete spinal ankylosis, severe spinal deformity, previous spinal surgery, or spinal trauma affecting the target treatment area;
  • Severe cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, malignancy, coagulation disorders, or other conditions considered unsuitable for the intervention;
  • Pregnancy or breastfeeding;
  • Cognitive impairment or communication difficulties that may affect outcome assessment;
  • Use of biologic agents, targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), systemic corticosteroids, or other immunomodulatory therapies within the previous month;
  • Previous acupotomy treatment at the target anatomical site within the previous 3 months;
  • Known metal allergy or severe fear of acupotomy procedures.

Treatment and study plan

Ultrasound-guided acupotomy

Procedure

Ultrasound-guided acupotomy will be performed once weekly for four consecutive weeks (W0-W3), for a total of four sessions. The target vertebral level and treatment sites will be identified by physical examination and ultrasound imaging. Following routine skin preparation and local anesthesia, the acupotomy needle will be advanced under real-time ultrasound guidance to the predefined interspinous and paraspinal treatment sites, where tissue release will be performed according to the standardized treatment protocol.

Sham Acupotomy

Procedure

Sham acupotomy will be performed once weekly for four consecutive weeks (W0-W3), for a total of four sessions. The same preliminary procedures as those used in the experimental group will be followed, including physical examination, ultrasound localization, skin preparation, and local anesthesia. The acupotomy needle will only penetrate superficially, without advancement to the target deep tissues or performance of tissue release.

Primary outcomes

  1. Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score

    Time frame: Week 4,one week after the final treatment session

    The primary outcome is the between-group difference in change from baseline in BASDAI score at week 4 after intervention.

Secondary outcomes

  1. Longitudinal changes in BASDAI scores at weeks 2, 4, and 8

    Time frame: Week 2,Week 4,Week 8

    The change from baseline in BASDAI will be assessed to evaluate disease activity after intervention.

  2. Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: Week 2,Week 4,Week 8

    The change from baseline in ASDAS will be assessed to evaluate disease activity after intervention.

  3. Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Week 2,Week 4,Week 8

    The change from baseline in BASFI will be assessed to evaluate functional impairment in patients with ankylosing spondylitis.

  4. Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Time frame: Week 2,Week 4,Week 8

    The change from baseline in BASMI will be assessed to evaluate spinal mobility.

  5. Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) score

    Time frame: Week 2,Week 4,Week 8

    The change from baseline in ASQoL score will be assessed to evaluate health-related quality of life.

  6. Change from baseline in Visual Analog Scale (VAS) pain score

    Time frame: Week 2,Week 4,Week 8

    The change from baseline in VAS pain score will be assessed to evaluate pain intensity.

  7. Incidence of adverse events

    Time frame: Baseline to Week 8

    Adverse events related to the intervention will be recorded throughout the study period, including bleeding, infection, local hematoma, and neurological symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuqiao Zhang

CONTACT

[email protected]

+86 13661102043

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Collaborators

  • The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Registry information

Official study title

Ultrasound-Guided Acupotomy for Ankylosing Spondylitis: A Protocol for a Participant- and Assessor-Blinded, Sham-Controlled Randomized Trial

Acronym: UGA-AS RCT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 11, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.