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
PROCEDUREAcupotomy
All subjects were enrolled at week 0 and, after completing baseline assessments, received acupotomy treatment once per week for a total of four sessions over the initial three-week period. The core intervention for the treatment group (acupotomy group) involved ultrasound-guided precise release: first, the target vertebra with the most significant lesions was identified through palpation and ultrasound imaging, after which the acupotomy was accurately guided in real-time via ultrasound to the interspinous points (located at the interspinous ligaments) and paraspinal points (located at the intertransverse ligaments) of the target vertebra and adjacent vertebrae for release.
PROCEDURESham Acupotomy
The control group (sham acupotomy group) strictly replicated all preliminary procedures of the treatment group, including exploration, ultrasound localization, and local anesthesia. However, the acupotomy needle only pierced the epidermis without performing any release operations in the deeper tissues, thereby maintaining blinding and assessing the specific effect of the acupotomy therapy.
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. Age 18-75 years 3. BASDAI ≥4 4. Signed informed consent form
Exclusion criteria
1. Presence of autoimmune diseases other than the studied condition 2. Complete spinal ankylosis or spinal deformity 3. Pregnant or lactating women 4. Comorbid severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, malignant tumors, or coagulation disorders 5. Patients unable to comply with data collection due to mental, linguistic, or similar factors 6. Patients with psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bath Ankylosing Spondylitis Disease Activity Index | Week 0，Week 4 | Based on the patient's symptoms over the past week, an assessment is conducted through six questions. The first five questions are scored using a Visual Analog Scale (VAS, 0-10 points). The calculation formula is generally expressed as: BASDAI = 0.2 × (A + B + C + D + (E + F)/2) Where: A represents the degree of fatigue/tiredness; B represents the degree of pain in the neck, back, or hips; C represents the degree of pain/swelling in other joints; D represents the level of discomfort from bodily tenderness or pressure pain; E represents the severity of morning stiffness; F represents the duration of morning stiffness (converted to a 0-10 score). BASDAI ≥4 indicates high disease activity, while a score \<4 suggests lower disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Bath Ankylosing Spondylitis Disease Activity Index | Week 0，Week 2，Week 8 | Based on the patient's symptoms over the past week, an assessment is conducted through six questions. The first five questions are scored using a Visual Analog Scale (VAS, 0-10 points). The calculation formula is generally expressed as: BASDAI = 0.2 × (A + B + C + D + (E + F)/2) Where: A represents the degree of fatigue/tiredness; B represents the degree of pain in the neck, back, or hips; C represents the degree of pain/swelling in other joints; D represents the level of discomfort from bodily tenderness or pressure pain; E represents the severity of morning stiffness; F represents the duration of morning stiffness (converted to a 0-10 score). BASDAI ≥4 indicates high disease activity, while a score \<4 suggests lower disease activity. |
| The Bath Ankylosing Spondylitis Functional Index | Week 0，Week 2，Week 4，Week 8 | The Bath Ankylosing Spondylitis Functional Index (BASFI) is a 10-item instrument used to measure functional limitation in patients with ankylosing spondylitis. Each item is scored on a 0 to 10 visual analog scale, where 0 indicates easy and 10 indicates impossible. The total score is calculated as the mean of the 10 item scores and ranges from 0 to 10. Higher scores indicate worse functional status. |
| Ankylosing Spondylitis Disease Activity Score based on C-reactive protein | Week 0，Week 2，Week 4，Week 8 | The Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) is a composite index used to measure disease activity in participants with ankylosing spondylitis. It combines patient-reported items and C-reactive protein (CRP) levels into a single score. The minimum score is 0, with lower scores indicating lower disease activity and higher scores indicating worse disease activity. There is no fixed maximum value because the upper end of the scale depends on the CRP level. ASDAS-CRP disease activity states are defined as inactive disease (\<1.3), moderate disease activity (1.3 to \<2.1), high disease activity (2.1 to ≤3.5), and very high disease activity (\>3.5). Clinically important improvement is defined as a decrease of at least 1.1 units, and major improvement is defined as a decrease of at least 2.0 units. |
| The Bath Ankylosing Spondylitis Metrology Index | Week 0，Week 2，Week 4，Week 8 | The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an instrument used to measure axial skeletal mobility in participants with ankylosing spondylitis. The total score ranges from 0 to 10. Lower scores indicate better spinal and hip mobility, while higher scores indicate greater limitation of movement and worse axial mobility. |
| The Ankylosing Spondylitis Quality of Life Scale | Week 0，Week 2，Week 4，Week 8 | The Ankylosing Spondylitis Quality of Life Scale (ASQoL) is a patient-reported instrument used to measure the impact of ankylosing spondylitis on health-related quality of life. The total score ranges from 0 to 18. Lower scores indicate better quality of life, while higher scores indicate worse quality of life. |
| Pain Score on the Visual Analogue Scale | Week 0，Week 2，Week 4，Week 8 | Pain due to ankylosing spondylitis measured on a 0 to 10 Visual Analogue Scale (VAS) over the past week, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. |
| Use of Rescue Medication | Week 0，Week 2，Week 4，Week 8 | Use of rescue medication during the study period, including medication type, dose, frequency, duration, and changes over time, prospectively recorded based on participant-reported and recorded medication use. |
Countries
China
Contacts
CONTACTYuqiao Zhang
Outcome results
None listed