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

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

Detailed Description
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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.

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

Conditions
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Psoriasis, Arthralgia

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture in active points<br>Patients in this group will receive real acupuncture | Other: Acupuncture<br>* Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group<br>|
| Sham Comparator: Acupuncture in non-active points<br>Patients in this group will receive acupuncture, but in non-active points | Other: Acupuncture<br>* Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group<br>|
| No Intervention: No treatment, just observation<br>Patients in this group will receive no treatment and will only be observed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |