Axial Spondyloarthritis
Conditions
Interventions
Treatment Group: Twelve-Character Formula Movement Acupuncture
Control Group:Adalimumab combined with traditional Chinese medicine (TCM) treatment
Sponsors
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 60 years regardless of gender; (2) Meeting the classification criteria for axial spondyloarthritis (AxSpA) established by the International Spondyloarthritis Assessment Society (ASAS) in 2009; (3) With low back pain or stiffness symptoms and an ASDAS-CRP score =1.3; (4) Capable of making judgments about general conditions and able to cooperate in evaluating symptoms signs and other items; (5) Requiring stable-dose use of adalimumab for 3 months and oral traditional Chinese medicine (TCM) compound preparations at a stable dose for 2 weeks before enrollment; (6) Providing informed consent to participate and signing the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with unilateral or bilateral joints meeting the AS radiological diagnostic criteria at grade IV; (2) Those who have participated in or are currently enrolled in other clinical trials within the past 3 months; (3) Individuals concurrently receiving other external treatments such as acupuncture or tuina (Chinese massage); (4) Patients with mental disorders or inability to cooperate; (5) Pregnant or lactating women, or those planning to conceive; (6) Individuals with severe cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or other systemic diseases; (7) Those with metal allergies or severe needle phobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankylosing Spondylitis Disease Activity Score based on C-reactive protein(ASDAS-CRP); | — |
Secondary
| Measure | Time frame |
|---|---|
| C-reactive protein (CRP);Bath Ankylosing Spondylitis Metrology Index(BASMI);Erythrocyte Sedimentation Rate (ESR);ASAS Health Index(ASAS HI);Bath AS Disease Activity Index(BASDAI);Bath Ankylosing Spondylitis Functional Index(BASFI); | — |
Countries
China
Contacts
Public ContactWang Xiao
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed