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Clinical evaluation of the efficacy and safety of extracorporeal shock wave treatment in patients with axial spondyloarthritis

Clinical evaluation of the efficacy and safety of extracorporeal shock wave treatment in patients with axial spondyloarthritis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037744
Enrollment
Unknown
Registered
2020-08-31
Start date
2020-09-15
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

axial spondyloarthritis

Interventions

Control Group:Simulation Therapy
Release Therapy Group:Shock wave release therapy
Focused Therapy Group:Shock wave focused therapy

Sponsors

Beijing Jishuitan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18to 45 years; (2) defined using the ASAS axial spondyloarthritis criteria in 2009; (3) identified as active axSpA during screening and baseline examination; (4) still met active axSpA when NSAIDs were used for 4 weeks and / or csDMARDs for 8 weeks before treatment (before randomization); (5) with the negative pregnancy test in female patient with child-bearing age; (6) agreed to take effective contraceptive measures during the study in fertile female; (7) willing to receive treatment according to the program and follow-up on time; (8) understand and sign informed consent form.

Exclusion criteria

Exclusion criteria: (1) diagnosed with other inflammatory arthritis, such as rheumatoid arthritis et al; (2) diagnosed with metabolic osteopathy; (3) diagnosed with infectious arthritis, such as intervertebral disc infection; (4) with complete spinal ankyloses; (5) occurred hemorrhagic disease or coagulation dysfunction; (6) with thrombosis in the treatment area; (7) accompanied by malignant diseases; (8) with mechanical low back pain; (9) with severe skin disease or ulceration in the treated area; (10) pregnant women; (11) with a history of severe drug abuse or alcohol abuse or mental illness with clinical symptoms; (12) participated in any clinical trial within 3 months before randomization; (13) not suitable for the study judgment by the researchers.

Design outcomes

Primary

MeasureTime frame
Bath Ankylosing Spondylitis Disease Activity Index;Visual Analogue Scale;

Secondary

MeasureTime frame
Ankylosing Spondylitis Disease Activity Score;Morning stiffness time;Patient's global assessment;Physician's global assessment;Bath Ankylosing Spondylitis Functional Index;MRI Score By Spondyloarthritis Research Consortium of Canada;Erythrocyte sedimentation rate;C-reactive protein;Measurement of spinal mobility;

Countries

China

Contacts

Public ContactLiu Yajun

Beijing Jishuitan Hospital

drliuyajun@163.com+86 13911878647

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026