Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome

Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Other: Fire needle; Other: Fire needle Placebo

Detailed Description

Psoriasis is a chronic inflammatory skin disease characterized by the complex interaction between the immune system, related susceptibility loci, autoantigens and various environmental factors. In China, the prevalence is about 0.47%. Current treatment strategies for psoriasis mainly focus on developing new drugs that disrupt IL-23 or IL-17 cytokine, but this targeted therapy is not effective for all patients. A growing body of evidence indicates that psoriasis-related damage is not limited to the skin, but is closely related to coronary heart disease, stroke, metabolic syndrome, and chronic kidney disease. These comorbidities have, to a certain extent, increased mortality in patients with psoriasis. Traditional Chinese medicine (TCM) has always been used to treat patients with psoriasis in China. Blood stasis syndrome is one of the basic syndromes of psoriasis. which accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for a long time and is similar to many metabolic related diseases. Fire needle therapy is one of the traditional Chinese specialty treatments, which has effects of warming yang to expel cold, warming and activating meridian, dispersing stasis and relieving pain. Studies have shown that fire needle therapy of plaque psoriasis in stationary phase is effective, with fewer side effects, and can reduce the recurrence rate. This multicenter, randomized, single-blind, placebo-controlled trial will objectively and standardly evaluate the clinical effectiveness, safety and control of recurrence of fire needle therapy to obtain objective evidence of international standards and form clinical norms suitable for popularization and application.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Shijiazhuang Hospital of Traditional Chinese Medicine
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China
      • First Affiliated Hospital of Heilongjiang Chinese Medicine University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Yueyang Integrated Medicine Hospital
  • Shanxi
    • Xi'an, Shanxi, China
      • Shanxi Provincial Hospital of Traditional Chinese Medicine

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. Comply with the diagnostic criteria of Western medicine for plaque psoriasis and the diagnostic criteria for TCM syndromes;
2. 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);
3. Age between 18 and 65 years old;
4. Those who voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
2. Other active skin diseases may affect the condition assessment;
3. Received research drugs, biological agents and immunosuppressive agents within 1 month;
4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
5. During severe, uncontrollable local or systemic acute or chronic infections;
6. 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;
7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
8. Such surgery will be required during major surgery or study during 8 weeks;
9. Pregnant or lactating women;
10. A person with a history of alcohol abuse, drug abuse or drug abuse;
11. Have a history of serious mental illness or family history;
12. Other reasons researchers believe that it is inappropriate to participate in this research.

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: Fire needle group; 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; 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.; 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.
Placebo Comparator: Fire needle placebo group; 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; 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.; 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.

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
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
Body surface area (BSA)	The percentage of body surface area (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
Patient-reported quality of life (PRQoL)	Patient-reported quality of life (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
TCM syndrome score	The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.	Up to 56 days after treatment

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Collaborators: Heilongjiang University of Chinese Medicine; The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine; Shijiazhuang Hospital of Traditional Chinese Medicine; Shaanxi Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

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 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 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; Fire Needle Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Skin Diseases; Gastrointestinal Diseases; Intestinal Diseases; Skin Diseases, Papulosquamous; Malabsorption Syndromes; Psoriasis; Blind Loop Syndrome
• Other Study ID Numbers: 2018YFC1705303-02

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