Ankylosing Spondylitis
Conditions
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.
Interventions
PROCEDUREUltrasound-guided acupotomy
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.
PROCEDURESham Acupotomy
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.
Sponsors
China-Japan Friendship Hospital
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Meeting the 1984 revised New York criteria or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis. 2. Aged 18-75 years. 3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAl) score ≥4. 4. Provision of written informed consent.
Exclusion criteria
1. Presence of other autoimmune or inflammatory rheumatic diseases that may affect outcome assessment, including psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis; 2. Complete spinal ankylosis, severe spinal deformity, previous spinal surgery, or spinal trauma affecting the target treatment area; 3. Severe cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, malignancy, coagulation disorders, or other conditions considered unsuitable for the intervention; 4. Pregnancy or breastfeeding; 5. Cognitive impairment or communication difficulties that may affect outcome assessment; 6. 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; 7. Previous acupotomy treatment at the target anatomical site within the previous 3 months; 8. Known metal allergy or severe fear of acupotomy procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score | 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
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal changes in BASDAI scores at weeks 2, 4, and 8 | Week 2，Week 4，Week 8 | The change from baseline in BASDAI will be assessed to evaluate disease activity after intervention. |
| Change from baseline to week 4 in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) | Baseline and week 4 (one week after the final treatment session) | 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. |
| Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) | Week 2，Week 4，Week 8 | The change from baseline in BASFI will be assessed to evaluate functional impairment in patients with ankylosing spondylitis. |
| Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) | Week 2，Week 4，Week 8 | The change from baseline in BASMI will be assessed to evaluate spinal mobility. |
| Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) score | Week 2，Week 4，Week 8 | The change from baseline in ASQoL score will be assessed to evaluate health-related quality of life. |
| Change from baseline in Visual Analog Scale (VAS) pain score | Week 2，Week 4，Week 8 | The change from baseline in VAS pain score will be assessed to evaluate pain intensity. |
| Incidence of adverse events | 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. |
Countries
China
Contacts
CONTACTYuqiao Zhang
Outcome results
None listed