An interventional study of Ultrasound-guided acupotomy and Sham Acupotomy in Ankylosing Spondylitis, sponsored by China-Japan Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment
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.
531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.
This study's planned enrollment of 60 is below the median of 88 across 302 interventional studies indexed under Spondylitis, Ankylosing.
Browse Spondylitis, Ankylosing studies →China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Ultrasound-guided acupotomy
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.
Procedure: Sham 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.
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.
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 8
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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