Ankylosing Spondylitis Clinical Trial
Official title:
Chung Shan Medical University Hospital, Taiwan
Tramadol 37.5 mg/APAP 325 mg combination tablets (ULTRACET®) were effective and safe as addon therapy with COX-2 NSAID for treatment of osteoarthritis (5) and chronic low back pain (6).There is no clinical trial regarding tramadol usage in chronic inflammatory arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis. It would be important to do a pilot clinical trial on add-on effect of tramadol to NSAID in patients with AS or RA.
Ankylosing spondylitis (AS) is a chronic inflammatory arthritis causing back pain,
peripheral arthritis and enthesitis due to genetic background and autoimmunity. Patients
with ankylosing spondylitis usually suffered from chronic pain over spine and peripheral
joints since their second or third decades. It may also cause severe social and
psychological burden to patients and their family.
Exercise and non-steroid anti-inflammatory drugs (NSAID) are the standard first-line
treatments for AS（1）. Only 50% of patients with AS reach the ASAS response criteria（2） in
clinical trials. Patients with severe disease activity should be put on disease-modifying
anti-rheumatic drugs (DMARD), such as sulfasalazine（3） and anti-TNF biological agents.
Add-on of acetaminophen and low dose anti-depressant （4）can slightly improve the response
rate. However, there is no data if tramadol or ultracet can benefit AS.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
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