Ozone Therapy in Ankylosing Spondylitis

NCT05429801 | Completed

• 1 other identifier: 60116787-020/14061
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

ozone therapy; complementary treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Bath Ankylosing Spondylitis Disease Activity Index

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

• Ankylosing Spondylitis Disease Activity Score

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

• Bath Ankylosing Spondylitis Functional Index

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

• Ankylosing Spondylitis Quality of Life

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

Study Arms (2)

Ozone Therapy

EXPERIMENTAL

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.

Other: Ozone therapy

Control group

ACTIVE COMPARATOR

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

Other: Ozone therapy

Interventions

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.

Control group; Ozone Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed as AS according to the Modified New York criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Hakan Alkan

Denizli, None Selected, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

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

Study Officials

• Füsun Ardıç, Prof

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 23, 2022
• Study Start: December 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: December 30, 2019
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)