Ozone Therapy in Ankylosing Spondylitis

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