Ozone Therapy in Ankylosing Spondylitis

Overview

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.

Full Title of Study: “Efficacy of Ozone Therapy in Patients With Ankylosing Spondylitis: A Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2019

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Ozone Therapy
    • 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.
  • Active Comparator: Control group
    • The patients in this group continued only their current medical treatment.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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.
  • 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
  • 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pamukkale University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hakan Alkan, Clinical Professor – Pamukkale University
  • Overall Official(s)
    • Füsun Ardıç, Prof, Study Director, Pamukkale University

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