Efficacy of Wet Cupping Therapy on Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Efficacy of Wet Cupping Therapy on Fibromyalgia Syndrome a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253482
• Other study ID #: WCT 7
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: October 2023
• Source: Karabuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 30, 2023
• Est. primary completion date: March 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Turkey	Umraniye Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline EuroQol-5D (EQ-5D-3L) quality of life scale scores at 3 month.	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.	At 0 and 3 months
Secondary	Change from baseline (At 0 month) Visual Analog Scale (VAS) scores at 3 month	VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases.	At 0 and 3 months