Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial

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

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.

Study Overview

• Status: Unknown
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Device: Moving cupping; Device: Moving cupping placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • First Affiliated Hospital, Heilongjiang University of Chinese Medicine
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Affiliated Hospital of Jiangxi University of TCM
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Shaanxi Provincial Hospital of traditional Chinese Medicine
  • Shijiazhuang
    • Shijiazhuang, Shijiazhuang, China
      • Shijiazhuang traditional Chinese medicine hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Diagnostic criteria for plaque psoriasis;
2. Skin lesions involve ≤10% BSA (the lesions are mainly located in the torso / limbs, palm / sole, face / scalp, vulva area is not included);
3. Aged between 18 and 65 years.
4. Consent to participate in the research study and sign the informed consent form

Exclusion Criteria:

1. Patients with pustular psoriasis, arthropathic, erythroderma psoriasis and / or drip psoriasis;
2. Plaque psoriasis patients with BSA>10%;
3. Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim;
4. 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;
5. Patients who used topical treatment within 2 weeks before the Baseline visit e.g. corticosteroids ultraviolet-light therapy including sunbathing;
6. Active infectious disease which was hard to control;
7. 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;
8. Family history of cancer-prone patients;
9. Patients with immunocompromised and can cause skin allergies and infection when moving cupping;
10. Pregnant or lactating women;
11. Patients with a history of alcohol abuse and drug abuse;
12. Have a history of serious mental illness or family history; 13 Other reasons researchers believe that patients are not suitable for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moving cupping intervention; 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; 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.
Placebo Comparator: Moving cupping placebo control; 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; Using of special perforated cups, the manipulation method is the same as the intervention group.

What is the study measuring?

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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Collaborators: Heilongjiang University of Chinese Medicine; Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital; The Affiliated Hospital of JiangXi University of TCM; Shaanxi Traditional Chinese Medicine Hospital; Shijiazhuang traditional Chinese medicine hospital
• Investigators: Study Chair: Jia Zhou, Shanghai Yueyang Integrated Medicine Hospital

Publications and helpful links

General Publications

• Xing M, Yan X, Yang S, Li L, Gong L, Liu H, Xu R, Chen J, Ying L, Zhao Y, An Y, Liu Y, Huang G, Guo F, Yin Q, Wang R, Li B, Li X. Effects of moving cupping therapy for plaque psoriasis: study protocol for a randomized multicenter clinical trial. Trials. 2020 Feb 26;21(1):229. doi: 10.1186/s13063-020-4155-0.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Plaque Psoriasis; Blood stasis syndrome; Moving cupping
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 2018YFC1705303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No