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NCT Number: NCT05429801

Ozone Therapy in Ankylosing Spondylitis

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hakan Alkan

Denizli, None Selected, 20100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ozone therapy

Other

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.

Primary outcomes

  1. visual analogue scale (VAS)

    Time frame: Change from baseline VAS at the 4th week after the treatment

    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).

Secondary outcomes

  1. Bath Ankylosing Spondylitis Disease Activity Index

    Time frame: Change from baseline Bath Ankylosing Spondylitis Disease Activity Index at the 4th week after the treatment

    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

  2. Ankylosing Spondylitis Disease Activity Score

    Time frame: Change from baseline Ankylosing Spondylitis Disease Activity Score at the 4th week after the treatment

    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.

  3. Bath Ankylosing Spondylitis Functional Index

    Time frame: Change from baseline Bath Ankylosing Spondylitis Functional Index at the 4th week after the treatment

    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

  4. Ankylosing Spondylitis Quality of Life

    Time frame: Change from baseline Ankylosing Spondylitis Quality of Life score at the 4th week after the treatment

    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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2022
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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