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FibromyalgiaNCT05253482

Efficacy of Wet Cupping Therapy on Fibromyalgia

A study testing wet cupping therapy in people with Fibromyalgia, run by Karabuk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Fibromyalgia
What is being tested?
wet cupping therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Jan 2022to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Umraniye Training and Research Hospital

    Istanbul, 34070

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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

Conditions
Fibromyalgia
Being tested
wet cupping therapy
Keywords
wet cupping therapy, fibromyalgia
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • wet cupping therapyProcedure or surgery

    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.

Study groups in NCT05253482
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention group will undergo 3 successive wet cupping therapy (WCT) sessions once in a month throughout 3 months (On 0, 30, and 60 days
Receives: Procedure: wet cupping therapy
Control groupNo interventionControl group will not receive any intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 0 and 3 months

Secondary outcomes (2)
  1. 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.

    Measured: At 0 and 3 months

  2. 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.

    Measured: At 0 and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start5 Jan 2022
  3. Primary completion5 Mar 2023
  4. Study completion30 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05253482
Sponsor's protocol ID
WCT 7
Status last verified
Oct 2023
First submitted
9 Feb 2022
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing wet cupping therapy in people with Fibromyalgia, run by Karabuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline (at 0 month) Fibromyalgia Impact Questionnaire (FIQ) scores at 3 month (time frame: At 0 and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

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