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Trials. 2019 Jun 17;20(1):358. doi: 10.1186/s13063-019-3475-4.

Auricular acupressure as a complementary therapy for psoriasis vulgaris: study protocol for a multicenter randomized controlled trial.

Deng J1,2, Lu C3,4, Xiang Y1,2,5,6, Deng H1,2, Wen Z7, Yao D1,2, Xuan M7, Yan Y1,2.

Author information

1
Psoriasis Clinical and Basic Research Team, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
2
Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China.
3
Psoriasis Clinical and Basic Research Team, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. luchuanjian888@vip.sina.com.
4
Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China. luchuanjian888@vip.sina.com.
5
Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, 510120, China.
6
School of Medical Information Engineering, Guangdong Pharmaceutical University, Guangzhou, 510006, China.
7
Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.

Abstract

INTRODUCTION:

Psoriasis vulgaris is a common skin disease characterized by persistent localized erythematous scaly plaques, typically on the elbows, knees, and scalp. It is an immune-abnormal disease that progresses slowly over a long period with frequent symptom recurrence. Current studies have shown that acupuncture is an effective therapy for psoriasis. However, the scientific evidence of the efficacy of auricular acupressure treatment for patients with psoriasis is still insufficient. Therefore, we designed a randomized controlled clinical trial to investigate the effect, safety, and cost-effectiveness of auricular acupressure in addition to medication in patients with psoriasis.

METHODS AND ANALYSIS:

This on-going study is a two-arm parallel, assessor-blinded, randomized controlled trial in which 180 participants with psoriasis will be recruited and then randomly allocated into two groups in a 1:1 ratio. Equal randomization will be conducted using a computer-generated random allocation sequence. Participants in the intervention group will receive auricular acupressure treatment once per week for 4 weeks, and calcipotriol betamethasone ointment for topical use once daily for 4 weeks. Participants in the control group will receive only calcipotriol betamethasone ointment treatment once daily for 4 weeks. All patients will be followed up for 12 weeks. The primary outcome is relapse rate. The secondary outcomes include time to relapse, rebound rate, time to new onset, Psoriasis Area and Severity Index score improvement rate, body surface area affected, a visual analogue scale, and Dermatology Life Quality Index. Cost-effectiveness analysis will be carried out from a health and community care provider perspective.

DISCUSSION:

This multicenter randomized controlled trial will provide important clinical evidence for the effect and safety of auricular acupressure as a complementary therapy in patients with psoriasis.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry, ChiCTR-TRC-14004916 . Registered on 20 May 2014. This protocol is version 3.0 which was updated on 24 September 2016.

PMID:
31208470
PMCID:
PMC6580514
DOI:
10.1186/s13063-019-3475-4
[Indexed for MEDLINE]
Free PMC Article

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