An interventional study of Ozone therapy in Ankylosing Spondylitis, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment
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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 30 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
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.
Other: Ozone therapy
The patients in this group continued only their current medical treatment.
Other: Ozone therapy
Rectal ozone treatment along with standard medical treatment was administered to the patients, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks. First week: 25 mg/l, 100 ml; second week: 30 mg/l, 150 ml; third week: 35 mg/l, 200 ml; fourth week: 40 mg/l, 200 ml rectal ozone treatment was applied.
visual analogue scale (VAS)
The patients were assessed for low back pain level according to the 10 cm visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain).
Time frame: Change from baseline VAS at the 4th week after the treatment
Bath Ankylosing Spondylitis Disease Activity Index
Bath Ankylosing Spondylitis Disease Activity Index was used to assess disease acticvity.The Bath Ankylosing Spondylitis Disease Activity Index has a range of 0 to 10; a lesser number represents less severe disease activity
Time frame: Change from baseline Bath Ankylosing Spondylitis Disease Activity Index at the 4th week after the treatment
Ankylosing Spondylitis Disease Activity Score
Ankylosing Spondylitis Disease Activity Score is a new composite index to assess disease activity which contains low back pain, global assessment of the patient, peripheral joint pain and swelling, duration of morning stiffness, and acute phase response parameters.Four disease activity states were chosen by consensus: inactive disease, moderate, high, and very high disease activity. The three cut-offs selected to separate these states were: 1.3, 2.1 and 3.5 units. Hihger score means higher disease activity.
Time frame: Change from baseline Ankylosing Spondylitis Disease Activity Score at the 4th week after the treatment
Bath Ankylosing Spondylitis Functional Index
The Bath Ankylosing Spondylitis Functional Index (BASFI) was used to determine the degree of functional limitation in patient with AS. The Bath Ankylosing Spondylitis Functional Index has a score between 0 and 10, with a higher score indicating more functional limitation
Time frame: Change from baseline Bath Ankylosing Spondylitis Functional Index at the 4th week after the treatment
Ankylosing Spondylitis Quality of Life
The disease-specific instrument Ankylosing Spondylitis Quality of Life (ASQoL) includes 18 yes or no questions related to the impact of disease on sleep, mood, motivation, coping, activities of daily living, independence, relationships, and social life with a total score of 0-18. Lower ASQoL scores represent a better QoL
Time frame: Change from baseline Ankylosing Spondylitis Quality of Life score at the 4th week after the treatment
Plan to share: No
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Pamukkale University