Efficacy of Wet Cupping Therapy on Fibromyalgia

NCT05253482 | Completed

• 1 other identifier: WCT 7
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background and purpose: Although wet cupping therapy (WCT) is in use, clinical investigations of its efficiency are scarce. The aim of this study was to evaluate the effects of wet cupping therapy (WCT) on fibromyalgia syndrome Methods: The patients will be randomized into two groups. WCT will be applied once a month to patients in the intervention group while the control group will be on standard therapy for fibromyalgia. An evaluation will be made before treatment and at the 3rd month using the Fibromyalgia Impact Survey (FEA), VAS, and EuroQol-5D (EQ-5D-3L) quality of life scale.

Conditions

Fibromyalgia

Keywords

wet cupping therapy; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change from baseline (at 0 month) Fibromyalgia Impact Questionnaire (FIQ) scores at 3 month

  This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.

  At 0 and 3 months

Secondary Outcomes (2)

• Change from baseline EuroQol-5D (EQ-5D-3L) quality of life scale scores at 3 month.

  At 0 and 3 months

• Change from baseline (At 0 month) Visual Analog Scale (VAS) scores at 3 month

  At 0 and 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will undergo 3 successive wet cupping therapy (WCT) sessions once in a month throughout 3 months (On 0, 30, and 60 days

Procedure: wet cupping therapy

Control group

NO INTERVENTION

Control group will not receive any intervention

Interventions

wet cupping therapy PROCEDURE

Vacuum cups will used on different acupuncture points to perform WCT: The one on the posterior median line, in the depression below the processus spinosus of the 7th cervical vertebra was DU 14 (Dazhui) point; the ones on the back, 3.0 cm lateral to the lower border of the spinous process of the 3rd thoracic vertebra interscapulum region were UB 42 (Pohu) bilateral points; and the ones on the back, 3.0 cm lateral to the lower border of the spinous process of the 7th thoracic vertebra were UB 46 (Geguan) bilateral points and additionally the patient's trigger points which we detect during the examination. There will be 5-7 points in total. The technique used will be triple S (Sucking, Scarification, Sucking) in all sessions.

Intervention group

Eligibility Criteria

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

You may not qualify if:

• Those who are accompanied with any chronic disease and on daily medication, contraindicated to WCT as determined in the routine blood tests that were routinely performed before the prior to application (Hgb \<9,5; INR\> 1,2,; Hgb \<9,5, etc) and who received WCT in the last three months will be excluded.

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, 34070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Emin Pala

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Training consultant

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 23, 2022
• Study Start: January 5, 2022
• Primary Completion: March 5, 2023
• Study Completion: July 30, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

TU (1)