Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome

NCT03953885 | Unknown DMC

• 1 other identifier: 2018YFC1705303-02
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

This study was designed as a multicenter, randomized, single blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of plaque psoriasis with blood stasis syndrome, after treated with fire needle therapy.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis; Blood stasis syndrome; Randomized controlled trial; Fire Needle Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Body surface area (BSA)

  Up to 56 days after treatment

• Physician Global Assessment (PGA)

  Up to 56 days after treatment

• Dermatology Life quality index(DLQI)

  Up to 28 days after treatment

• Patient-reported quality of life (PRQoL)

  Up to 28 days after treatment

• Visual Analogue Score (VAS)

  Up to 56 days after treatment

Study Arms (2)

Fire needle group

EXPERIMENTAL

Participants in experimental group will receive Fire needle 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.

Other: Fire needle

Fire needle placebo group

PLACEBO COMPARATOR

Participants in experimental group will receive Fire needle 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.

Other: Fire needle Placebo

Interventions

Fire needle OTHER

1. Participants wear eye masks and fully expose the lesions. After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation. After selecting an acupuncture needle with a specification of 0.4\*40mm and ignites the alcohol lamp, the operator continuously moves the needle from the needle root to the needle tip to burn the red needle to disinfect the needle in the outer flame of the alcohol lamp. 2. The operator ignites the alcohol lamp, and burns the needle tip and the needle body to the outer flame of the alcohol lamp until it is completely red (the length of the needle burning red is determined by the acupuncture depth), and then rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm.

Fire needle group

Fire needle Placebo OTHER

1. Participants wear eye masks and fully expose the lesions (no lesions on the head and face, external genitalia and skin folds). After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation, then selects an acupuncture needle with a specification of 0.4\*40mm to prepare for operation. 2. The operator rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm.

Fire needle placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Comply with the diagnostic criteria of Western medicine for plaque psoriasis and the diagnostic criteria for TCM syndromes;
• Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);
• Age between 18 and 65 years old;
• Those who voluntarily participate in the study and sign informed consent.

You may not qualify if:

• Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
• Other active skin diseases may affect the condition assessment;
• Received research drugs, biological agents and immunosuppressive agents within 1 month;
• weeks of treatment with topical glucocorticoids, phototherapy, etc.;
• During severe, uncontrollable local or systemic acute or chronic infections;
• Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by \>1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;
• A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
• Such surgery will be required during major surgery or study during 8 weeks;
• Pregnant or lactating women;
• A person with a history of alcohol abuse, drug abuse or drug abuse;
• Have a history of serious mental illness or family history;
• Other reasons researchers believe that it is inappropriate to participate in this research.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead
• Shaanxi Provincial Hospital of Traditional Chinese Medicine: collaborator
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine: collaborator
• Shijiazhuang Hospital of Traditional Chinese Medicine: collaborator
• Heilongjiang University of Chinese Medicine: collaborator

Study Sites (5)

Shijiazhuang Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

Location

First Affiliated Hospital of Heilongjiang Chinese Medicine University

Harbin, Heilongjiang, China

Location

Affiliated hospital of jiangxi university of traditional Chinese medicine

Nanchang, Jiangxi, China

Location

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Provincial Hospital of Traditional Chinese Medicine

Xi’an, Shanxi, China

Location

Related Publications (1)

• Liu L, Lu Y, Yan XN, Yang SQ, Gong LP, Li LE, Zhao YD, Yin QF, Wang RP, An YP, Huang G, Zhang JF, Sun XY, Li X, Li B. Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial. Trials. 2020 Aug 25;21(1):739. doi: 10.1186/s13063-020-04691-7.

  PMID: 32843084 DERIVED

Study Officials

• Jia Zhou

  Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai

  STUDY CHAIR

Central Study Contacts

Bin Li

CONTACT

0086-021-55981301; 18930568129@163.com

Ting Dai

CONTACT

0086-021-65161782-3137; tingdai@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 17, 2019

Record last verified: 2019-05

Locations

CN (5)