Ozone Therapy in Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

Efficacy of Ozone Therapy in Patients With Ankylosing Spondylitis: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429801
• Other study ID #: 60116787-020/14061
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2022
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a 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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hakan Alkan	Denizli	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline VAS at the 4th week after the treatment
Secondary	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	Change from baseline Bath Ankylosing Spondylitis Disease Activity Index at the 4th week after the treatment
Secondary	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.	Change from baseline Ankylosing Spondylitis Disease Activity Score at the 4th week after the treatment
Secondary	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	Change from baseline Bath Ankylosing Spondylitis Functional Index at the 4th week after the treatment
Secondary	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	Change from baseline Ankylosing Spondylitis Quality of Life score at the 4th week after the treatment