Wet Cupping Therapy in Ankylosing Spondylitis

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Procedure: wet cupping therapy

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karabuk, Turkey
    • Karabuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BASFI	Change in the scores of The Bath Ankylosing Spondylitis Functional Index	At 0 and 3 months
BASDAI	Change in the scores of The Bath Ankylosing Spondylitis Disease Activity Index	At 0 and 3 months
VAS	Change in the scores of Visual Analogue Scale	At 0 and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schober	Change in the scores of Modified Schober Test	At 0 and 3 months

Collaborators and Investigators

• Sponsor: Karabuk University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ankylosing Spondylitis; Wet cupping therapy; Basfi; Basdai; Vas
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: SBU177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No