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Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome

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ClinicalTrials.gov Identifier: NCT03953885
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborators:
Shaanxi Provincial Hospital of Traditional Chinese Medicine
Affiliated hospital of jiangxi university of traditional Chinese medicine
Shijiazhuang Hospital of Traditional Chinese Medicine
Heilongjiang University of Chinese Medicine
Information provided by (Responsible Party):
Shanghai Yueyang Integrated Medicine Hospital

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Other: Fire needle Other: Fire needle Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fire Needle Therapy on Plaque Psoriasis With Blood Stasis Syndrome: A Randomized, Single-blind, Multicentre Clinical Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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
  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.

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
  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.




Primary Outcome Measures :
  1. Psoriasis area and severity index (PASI) [ Time Frame: Up to 56 days after treatment ]
    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.


Secondary Outcome Measures :
  1. Body surface area (BSA) [ Time Frame: Up to 56 days after treatment ]
    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 (%)

  2. Physician Global Assessment (PGA) [ Time Frame: Up to 56 days after treatment ]
    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)].

  3. Dermatology Life quality index(DLQI) [ Time Frame: Up to 28 days after treatment ]
    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.

  4. Patient-reported quality of life (PRQoL) [ Time Frame: Up to 28 days after treatment ]
    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.

  5. Visual Analogue Score (VAS) [ Time Frame: Up to 56 days after treatment ]
    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).

  6. TCM syndrome score [ Time Frame: Up to 56 days after treatment ]
    The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953885


Contacts
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Contact: Bin Li 0086-021-55981301 18930568129@163.com
Contact: Ting Dai 0086-021-65161782-3137 tingdai@hotmail.com

Locations
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China, Hebei
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
China, Heilongjiang
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Ha'erbin, Heilongjiang, China
China, Jiangxi
Affiliated hospital of jiangxi university of traditional Chinese medicine
Nanchang, Jiangxi, China
China, Shanghai
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai, China
China, Shanxi
Shanxi Provincial Hospital of Traditional Chinese Medicine
Xi'an, Shanxi, China
Sponsors and Collaborators
Shanghai Yueyang Integrated Medicine Hospital
Shaanxi Provincial Hospital of Traditional Chinese Medicine
Affiliated hospital of jiangxi university of traditional Chinese medicine
Shijiazhuang Hospital of Traditional Chinese Medicine
Heilongjiang University of Chinese Medicine
Investigators
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Study Chair: Jia Zhou Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai

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Responsible Party: Shanghai Yueyang Integrated Medicine Hospital
ClinicalTrials.gov Identifier: NCT03953885     History of Changes
Other Study ID Numbers: 2018YFC1705303-02
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Yueyang Integrated Medicine Hospital:
Plaque Psoriasis
Blood stasis syndrome
Randomized controlled trial
Fire Needle Therapy

Additional relevant MeSH terms:
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Psoriasis
Blind Loop Syndrome
Skin Diseases, Papulosquamous
Skin Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases