Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis

Psoriasis Clinical Trial

Official title:

Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02047851
• Other study ID #: H-1-2013-122
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 9, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether acupuncture is helpful for patients with joint pain associated with psoriasis

Description:

In this study, patients with psoriasis and joint pain will receive either real acupuncture or sham acupuncture to see if acupuncture can be an effective treatment of joint pain in patients with psoriasis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 9, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Plaque psoriasis

• Pain from at least two peripheral joints and/or inflammatory back pain

• No or stabile treatment of the psoriasis the last 3 months

• No or stabile pain treatment the last 3 months

• Oral and written information given

• Written consent signed

Exclusion Criteria:

• Arthritis with Ultrasound verified intra articular fluid og clinical verified joint swelling

• Pregnancy og breastfeeding

• Previous treatments with acupuncture

• Treatment with anticoagulants (vitamin K-antagonists, low molecular weight heparin, unfractionated heparin, direct thrombin inhibitors, direct factor Xa inhibitors)

• Unwilling to follow protocol

Related Conditions & MeSH terms

• Arthralgia
• Psoriasis

Intervention

Other:
• Acupuncture
Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group

Locations

Country	Name	City	State
Denmark	Gentofte University hospital	Hellerup
Denmark	The departement of allergy and dermatology, Gentofte Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Aage Bangs Fond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured on the VAS	Patients will record their level of pain in a journal each day, ranging from 0 to 10 where 0 is no pain and 10 is worst possible pain.	From day 0 to day 60 of the trial
Primary	Improvement in life quality measured with the DLQI (Dermatology Life Quality Index)	On day 0, 30 and 60 the patients will fill out a simple questionnaire with 10 questions concerning their life quality	From day 0 to day 60 of the study period
Secondary	Approvement in skin lesions	At each of the 3 control visits the patients will be asked if their psoriatic skin lesions have become better from the acupuncture, and if they say yes, how much better? Minimal improvement, moderate improvement og big improvement?	From day 0 to day 60 of the study period