Brief Title
Ozone Therapy in Ankylosing Spondylitis
Official Title
Efficacy of Ozone Therapy in Patients With Ankylosing Spondylitis: A Randomized Controlled Study
Brief Summary
The aim of this study was to investigate the effects of rectal ozone therapy added to medical treatment on pain severity, disease activity, spinal mobility, functional status, enthesitis, and quality of life (QoL) in patients with ankylosing spondylitis (AS). Patients and methods: Patients who fulfilled the modified New York criteria for AS were included in this randomized controlled study. Thirty patients selected according to inclusion and exclusion criteria were randomized into two groups. Rectal ozone treatment along with medical treatment was administered to the patients in group 1, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks. The patients in group 2 continued only their current medical treatment. All patients received a comprehensive rheumatologic assessment including pain severity, disease-specific instruments for disease activity, functional status, spinal mobility, enthesitis score, and QoL.
Study Type
Interventional
Primary Outcome
visual analogue scale (VAS)
Secondary Outcome
Bath Ankylosing Spondylitis Disease Activity Index
Condition
Ankylosing Spondylitis
Intervention
Ozone therapy
Study Arms / Comparison Groups
Ozone Therapy
Description: Rectal ozone treatment along with medical treatment was administered to the patients in this group, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
30
Start Date
December 1, 2018
Completion Date
December 30, 2019
Primary Completion Date
July 1, 2019
Eligibility Criteria
Inclusion Criteria: - Patients who were diagnosed as AS according to the Modified New York criteria Exclusion Criteria: - having other concomitant rheumatic diseases, - receiving anti-TNF-α therapy within the last 3 months, - being in clinical remission with standard medical treatment, - being pregnant, - having diseases such as favism, asthma, pancreatitis, and uncontrolled hyperthyroidism for which ozone therapy is contraindicated.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Füsun Ardıç, Prof, ,
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT05429801
Organization ID
60116787-020/14061
Responsible Party
Principal Investigator
Study Sponsor
Pamukkale University
Study Sponsor
Füsun Ardıç, Prof, Study Director, Pamukkale University
Verification Date
June 2022