Health TrialsbyHealthPanel

A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis

ConditionAnkylosing Spondylitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChina-Japan Friendship Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided acupotomy

    Procedure/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 Acupotomy

    Procedure/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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Ultrasound-guided acupotomy groupExperimental treatment 1 intervention
Group B: Sham acupotomy groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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.

Time frame
Week 2，Week 4，Week 8
2

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

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

Time frame
Week 2，Week 4，Week 8
3

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.

Time frame
Week 2，Week 4，Week 8
4

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

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

Time frame
Week 2，Week 4，Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov
Apply now