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Ozone Therapy in Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ozone therapy
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ozone therapy, complementary treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hakan Alkan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ozone Therapy

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Bath Ankylosing Spondylitis Disease Activity Index
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
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
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
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

Full Information

First Posted
June 13, 2022
Last Updated
June 22, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05429801
Brief Title
Ozone Therapy in Ankylosing Spondylitis
Official Title
Efficacy of Ozone Therapy in Patients With Ankylosing Spondylitis: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ozone therapy, complementary treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozone Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patients in this group continued only their current medical treatment.
Intervention Type
Other
Intervention Name(s)
Ozone therapy
Intervention Description
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 Outcome Measure Information:
Title
visual analogue scale (VAS)
Description
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).
Time Frame
Change from baseline VAS at the 4th week after the treatment
Secondary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Disease Activity Index
Description
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
Time Frame
Change from baseline Bath Ankylosing Spondylitis Disease Activity Index at the 4th week after the treatment
Title
Ankylosing Spondylitis Disease Activity Score
Description
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.
Time Frame
Change from baseline Ankylosing Spondylitis Disease Activity Score at the 4th week after the treatment
Title
Bath Ankylosing Spondylitis Functional Index
Description
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
Time Frame
Change from baseline Bath Ankylosing Spondylitis Functional Index at the 4th week after the treatment
Title
Ankylosing Spondylitis Quality of Life
Description
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
Time Frame
Change from baseline Ankylosing Spondylitis Quality of Life score at the 4th week after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Füsun Ardıç, Prof
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Hakan Alkan
City
Denizli
State/Province
None Selected
ZIP/Postal Code
20100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Ozone Therapy in Ankylosing Spondylitis

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