Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study was to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.

Detailed Description
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Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost. Complementary and alternative medicine (CAM) therapies have become an increasingly visible part of dermatology. Cupping is becoming an important therapy in complementary and alternative medicine. Although, moving cupping therapy has been widely used in the treatment of plaque psoriasis and has been recognized by a large number of peers and patients, but still lacks high-quality evidence-based medical evidence. Therefore, the project team intends to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.

Official Title
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Clinical Evaluation of Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Device: Moving cupping
* Device: Moving cupping placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic criteria for plaque psoriasis; Skin lesions involve ≤10% BSA (the lesions are mainly located in the torso / limbs, palm / sole, face / scalp, vulva area is not included); Aged between 18 and 65 years. Consent to participate in the research study and sign the informed consent form Exclusion Criteria: Patients with pustular psoriasis, arthropathic, erythroderma psoriasis and / or drip psoriasis; Plaque psoriasis patients with BSA>10%; Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim; Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit e.g.: drugs for other studies, immuno-suppressive drugs, biologics; Patients who used topical treatment within 2 weeks before the Baseline visit e.g. corticosteroids ultraviolet-light therapy including sunbathing; Active infectious disease which was hard to control; History of severe systemic disease. Or the clinical test index is one of the following: the ALT or the AST is higher than 1.5 times; Any of the main routine blood indexes (WBC, RBC, HB, PLT) is lower than the limit of normal; or other laboratory abnormalities and patients were judged not to be suitable for this study; Family history of cancer-prone patients; Patients with immunocompromised and can cause skin allergies and infection when moving cupping; Pregnant or lactating women; Patients with a history of alcohol abuse and drug abuse; Have a history of serious mental illness or family history; 13 Other reasons researchers believe that patients are not suitable for this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moving cupping intervention<br>Participants will received moving cupping therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment. | Device: Moving cupping<br>* We use a black opaque eye mask to shield the patient's eyes and choose different sizes of cup according to the location of the treatment (There are three sizes of cups) (1) First apply Vaseline to the skin lesions area; (2) Then hold the 95% ethanol cotton ball with tweezers, and hold the cup with the facing down, after the cotton ball is ignited, immediately sway down in the cup and then exit, and quickly buckle the cup to the skin lesions area. (3) After using the cup to absorb the skin lesions area, hold the cup body in one hand and push and pull the cup along the certain route with a little strength, so that the skin purple color of the treatment area is suitable. (4) Apply even force when pushing the cup to prevent the cup from falling off due to air leakage. (5) Acting on the skin lesions area 30 times, change cup 5 times per push and pull, the interval is not more than 10 seconds.<br>|
| Placebo Comparator: Moving cupping placebo control<br>Participants will received moving cupping placebo therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment. | Device: Moving cupping placebo<br>* Using of special perforated cups, the manipulation method is the same as the intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis area and severity index (PASI) | Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis. | Up to 56 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body surface area (BSA) | The percentage of BSA involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%). | Up to 56 days after treatment | 
| Physician Global Assessment (PGA) | Physician Global Assessment (PGA) is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), desquamation (D) across all psoriatic lesions. It is calculated as follows: PGA score = (E + I + D) / 3, then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0) - Very Severe (5)]. | Up to 56 days after treatment | 
| Dermatology Life quality index(DLQI) | The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life. | Up to 28 days after treatment | 
| Patient-reported quality of life (PRQoL) | PRQoL is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life. | Up to 28 days after treatment | 
| Visual Analogue Score (VAS) | Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis). | Up to 56 days after treatment | 
| CM symptom score | The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment. | Up to 28 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Plaque Psoriasis, Blood stasis syndrome, Moving cupping