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Wet Cupping Therapy in Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
wet cupping therapy
Sponsored by
Karabuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, Wet cupping therapy, Basfi, Basdai, Vas

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Clinical diagnosis of ankylosing spondylitis 18-65 years of age Consent to participate Exclusion Criteria: Any ongoing medical treatment other than NSAIDs Pregnancy At least one contraindication to WCT that was detected in subject's history or in the routine blood examinations prior to enrollment (Hgb <9.5; INR> 1.2; history of hemophobia, bleeding disorder, malignant disorder).

Sites / Locations

  • Karabuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wet cupping arm

Control arm

Arm Description

This arm is the interventiom group and will receive three consecutive sessions of wet cupping therapy once a month.

This arm is the control group and will not receive any intervention other than the routine medications

Outcomes

Primary Outcome Measures

BASFI
Change in the scores of The Bath Ankylosing Spondylitis Functional Index
BASDAI
Change in the scores of The Bath Ankylosing Spondylitis Disease Activity Index
VAS
Change in the scores of Visual Analogue Scale

Secondary Outcome Measures

Schober
Change in the scores of Modified Schober Test

Full Information

First Posted
March 7, 2023
Last Updated
March 18, 2023
Sponsor
Karabuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05792358
Brief Title
Wet Cupping Therapy in Ankylosing Spondylitis
Official Title
Wet Cupping Therapy in Ankylosing Spondylitis: a Multicenter Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This study evaluates the efficacy of wet cupping therapy in patients with ankylosing spondylitis.Wet cupping therapy will be applied to half of the patients plus routine pharmaceutical treatment while the other half will receive only pharmaceutics
Detailed Description
In addition to the medical treatment, WCT will be applied once a month, 3 times (Day 0, 30, 60) to the intervention group whereas the control group will not receive any intervention. The BASFI, BASDAI, VAS and Schober test will be applied to both groups at 0 and 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis, Wet cupping therapy, Basfi, Basdai, Vas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wet cupping arm
Arm Type
Experimental
Arm Description
This arm is the interventiom group and will receive three consecutive sessions of wet cupping therapy once a month.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
This arm is the control group and will not receive any intervention other than the routine medications
Intervention Type
Procedure
Intervention Name(s)
wet cupping therapy
Intervention Description
wet cupping therapy will be applied to participants in this arm for three sessions once a month
Primary Outcome Measure Information:
Title
BASFI
Description
Change in the scores of The Bath Ankylosing Spondylitis Functional Index
Time Frame
At 0 and 3 months
Title
BASDAI
Description
Change in the scores of The Bath Ankylosing Spondylitis Disease Activity Index
Time Frame
At 0 and 3 months
Title
VAS
Description
Change in the scores of Visual Analogue Scale
Time Frame
At 0 and 3 months
Secondary Outcome Measure Information:
Title
Schober
Description
Change in the scores of Modified Schober Test
Time Frame
At 0 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of ankylosing spondylitis 18-65 years of age Consent to participate Exclusion Criteria: Any ongoing medical treatment other than NSAIDs Pregnancy At least one contraindication to WCT that was detected in subject's history or in the routine blood examinations prior to enrollment (Hgb <9.5; INR> 1.2; history of hemophobia, bleeding disorder, malignant disorder).
Facility Information:
Facility Name
Karabuk University
City
Karabuk
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Wet Cupping Therapy in Ankylosing Spondylitis

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