Efficacy of Wet Cupping Therapy on Fibromyalgia

• ClinicalTrials.gov Identifier: NCT05253482
• Recruitment Status: Completed
• First Posted: February 23, 2022
• Last Update Posted: October 5, 2023
• Sponsor: Karabuk University
• Information provided by (Responsible Party): SULEYMAN ERSOY, Saglik Bilimleri Universitesi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Procedure: wet cupping therapy	Not Applicable

Detailed Description:

Background: Cupping therapy is a traditional treatment method especially belonging to our geography. In addition to being on the agenda as a traditional treatment method all over the world in recent years, it has also been the subject of an increasing number of scientific studies in the medical literature. In addition to studies investigating positive effects on blood biochemistry such as reducing LDL and TGS levels (1,2), removing heavy metals from the blood (3), there are also studies showing that it is effective in the treatment of migraine (4) and in the treatment of nonspecific low back pain (5). As a result of clinical studies, it was determined that cupping is effective in painful conditions (headache, myofascial pain, fibromyalgia), calcification, gonorrhea, spondylosis.

It has also been found to be effective in skin diseases (such as acne, herpes zoster), vascular diseases, blood pressure problems, lung and respiratory diseases, and some psychiatric disorders (as a tranquilizer in depression, schizophrenia)(6,7,8,9,10,11, 12,13). It has been suggested that wet cupping therapy stimulates healing by removing inflammatory mediators and toxins from the body. Some practitioners claim that it reduces or even seizes pain by regulating the autonomic nervous system. (13).

Purpose: The aim of our study is to investigate how and to what extent wet cupping therapy will affect the patients diagnosed with fibromyalgia.

Method: The patients who were referred to Umraniye Training Hospital Physical Therapy and Rehabilitation Polyclinic will be enrolled in the study.

The inclusion criteria are being 18-65 years old, having been diagnosed with fibromyalgia (ACR 2016 diagnosis criteria), and consenting to participate in the study. 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.

The volunteers will be randomized into two separate groups as study and control group Control group will not receive any intervention while the study group will undergo 3 successive WCT sessions once in a month throughout 3 months (On 0, 30, and 60 days). 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.

At 0 and 3 months, to both patient groups those questionnaires: Fibromyalgia Impact Survey (FEA), VAS, and EuroQol-5D (EQ-5D-3L) quality of life scale will be applied. Evaluation will be made between two groups regarding the scores of those scales

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Wet Cupping Therapy on Fibromyalgia Syndrome a Randomised Controlled Trial
• Actual Study Start Date: January 5, 2022
• Actual Primary Completion Date: March 5, 2023
• Actual Study Completion Date: July 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention group; 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; 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.
No Intervention: Control group; Control group will not receive any intervention

Outcome Measures

Primary Outcome Measures :

1. Change from baseline (at 0 month) Fibromyalgia Impact Questionnaire (FIQ) scores at 3 month [ Time Frame: At 0 and 3 months ]
   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.

Secondary Outcome Measures :

1. Change from baseline EuroQol-5D (EQ-5D-3L) quality of life scale scores at 3 month. [ Time Frame: At 0 and 3 months ]
   The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
2. Change from baseline (At 0 month) Visual Analog Scale (VAS) scores at 3 month [ Time Frame: At 0 and 3 months ]
   VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• The inclusion criteria are being 18-65 years old, having been diagnosed as fibromyalgia (ACR 2016 diagnosis criteria) and consenting to participate in the study

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Turkey

Umraniye Training and Research Hospital

Istanbul, Turkey, 34070

Sponsors and Collaborators

Karabuk University

Investigators

• Study Chair: Emin Pala; Saglik Bilimleri Universitesi

More Information

• Responsible Party: SULEYMAN ERSOY, Training consultant, Saglik Bilimleri Universitesi
• ClinicalTrials.gov Identifier: NCT05253482
• Other Study ID Numbers: WCT 7
• First Posted: February 23, 2022
• Last Update Posted: October 5, 2023
• Last Verified: October 2023

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

Keywords provided by SULEYMAN ERSOY, Saglik Bilimleri Universitesi:

wet cupping therapy; fibromyalgia

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases