Wet Cupping Therapy in Ankylosing Spondylitis

Sponsor

Karabuk University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05792358

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ankylosing Spondylitis	Procedure: wet cupping therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Wet Cupping Therapy in Ankylosing Spondylitis: a Multicenter Randomised Controlled Trial

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wet cupping arm This arm is the interventiom group and will receive three consecutive sessions of wet cupping therapy once a month.	Procedure: wet cupping therapy wet cupping therapy will be applied to participants in this arm for three sessions once a month
No Intervention: Control arm This arm is the control group and will not receive any intervention other than the routine medications

Arm

Intervention/Treatment

Experimental: Wet cupping arm

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

Procedure: wet cupping therapy

wet cupping therapy will be applied to participants in this arm for three sessions once a month

No Intervention: Control arm

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

Outcome Measures

Primary Outcome Measures

BASFI [At 0 and 3 months]
Change in the scores of The Bath Ankylosing Spondylitis Functional Index
BASDAI [At 0 and 3 months]
Change in the scores of The Bath Ankylosing Spondylitis Disease Activity Index
VAS [At 0 and 3 months]
Change in the scores of Visual Analogue Scale

Secondary Outcome Measures

Schober [At 0 and 3 months]
Change in the scores of Modified Schober Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).