A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis

Sponsor
China-Japan Friendship Hospital
Study ID
NCT07578220
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound-guided acupotomy — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
May 11, 2026
Start date
Dec 2, 2025
Status verified
Sep 2026
Primary completion
Apr 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ultrasound-guided acupotomy group
    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.
  • Sham Comparator: Sham acupotomy group
    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.

Primary Outcome Measure

Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score [ Time Frame: Week 4,one week after the final treatment session ]

Central Contacts

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