The Second Affiliated Hospital of Henan University of Chinese Medicine
Henan, Zhengzhou, 450002, China
Location status: Recruiting
NCT Number: NCT07578220
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Henan, Zhengzhou, 450002, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Week 2,Week 4,Week 8
The change from baseline in BASDAI will be assessed to evaluate disease activity after intervention.
Time frame: Week 2,Week 4,Week 8
The change from baseline in ASDAS will be assessed to evaluate disease activity after intervention.
Time frame: Week 2,Week 4,Week 8
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
The change from baseline in BASMI will be assessed to evaluate spinal mobility.
Time frame: Week 2,Week 4,Week 8
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
The change from baseline in VAS pain score will be assessed to evaluate pain intensity.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
China-Japan Friendship Hospital
Other
Ultrasound-Guided Acupotomy for Ankylosing Spondylitis: A Protocol for a Participant- and Assessor-Blinded, Sham-Controlled Randomized Trial
Acronym: UGA-AS RCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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