Ankylosing SpondylitisUGA-AS RCTNCT07578220
A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis
A study testing Ultrasound-guided acupotomy in people with Ankylosing Spondylitis, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Ultrasound-guided acupotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2025to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Henan University of Chinese Medicine
Henan, Zhengzhou, 450002
Zhou Zipeng, 13613863247, 13613863247@163.com
About this study
Official title: Ultrasound-Guided Acupotomy for Ankylosing Spondylitis: A Protocol for a Participant- and Assessor-Blinded, Sham-Controlled Randomized Trial
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
- Being tested
- Ultrasound-guided acupotomy, Sham Acupotomy
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided acupotomyProcedure or surgery
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 AcupotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided acupotomy group | Experimental | Participants assigned to the experimental group will receive ultrasound-guided acupotomy once weekly for four consecutive weeks (W0-W3), for a total of four treatment sessions. Before each treatment, 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. Receives: Procedure: Ultrasound-guided acupotomy |
| Sham acupotomy group | Sham comparator | Participants assigned to the sham comparator group will receive a sham acupotomy procedure once weekly for four consecutive weeks (W0-W3), for a total of four sessions. The sham procedure will replicate the preliminary procedures used in the experimental group, including physical examination, ultrasound localization, skin preparation, and local anesthesia. However, the acupotomy needle will only penetrate superficially and no deep tissue release will be performed. Receives: Procedure: Sham Acupotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
The primary outcome is the between-group difference in change from baseline in BASDAI score at week 4 after intervention.
Measured: Week 4,one week after the final treatment session
Secondary outcomes (7)
Longitudinal changes in BASDAI scores at weeks 2, 4, and 8
The change from baseline in BASDAI will be assessed to evaluate disease activity after intervention.
Measured: Week 2，Week 4，Week 8
Change from baseline to week 4 in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
The Ankylosing Spondylitis Disease Activity Score calculated using C-reactive protein (ASDAS-CRP) will be assessed at baseline and week 4 only. The score combines patient-reported symptoms and patient global assessment with CRP. Higher scores indicate greater disease activity. Change will be calculated as the week-4 score minus the baseline score; a negative change indicates improvement. Week 4 is one week after the final treatment session.
Measured: Baseline and week 4 (one week after the final treatment session)
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The change from baseline in BASFI will be assessed to evaluate functional impairment in patients with ankylosing spondylitis.
Measured: Week 2，Week 4，Week 8
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
The change from baseline in BASMI will be assessed to evaluate spinal mobility.
Measured: Week 2，Week 4，Week 8
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) score
The change from baseline in ASQoL score will be assessed to evaluate health-related quality of life.
Measured: Week 2，Week 4，Week 8
Change from baseline in Visual Analog Scale (VAS) pain score
The change from baseline in VAS pain score will be assessed to evaluate pain intensity.
Measured: Week 2，Week 4，Week 8
Incidence of adverse events
Adverse events related to the intervention will be recorded throughout the study period, including bleeding, infection, local hematoma, and neurological symptoms.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start2 Dec 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Qingwen Tao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578220
- Sponsor's protocol ID
- 2025-KY-458-4
- Other IDs
- MR-41-26-017970
- Acronym
- UGA-AS RCT
- Status last verified
- Oct 2026
- First submitted
- 5 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No