Ozone Therapy in Ankylosing Spondylitis

Pamukkale University

Status: Completed

Conditions: Ankylosing Spondylitis

Treatments: Other: Ozone therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05429801

60116787-020/14061

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Ozone Therapy

Experimental group

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.

Treatment:

Other: Ozone therapy

Control group

Active Comparator group

Description:

The patients in this group continued only their current medical treatment.

Treatment:

Other: Ozone therapy