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

Not Applicable

Terminated

• Conditions: Psoriasis; Arthralgia
• Interventions: Other: Acupuncture

• Registration Number: NCT02047851
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-01-26
• Study First Submitted QC: 2014-01-26
• Study First Posted: 2014-01-28
• Study Start: 2014-10
• Primary Completion: 2018-05-09
• Study Completion: 2018-05-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture in active points	Acupuncture	Patients in this group will receive real acupuncture
Acupuncture in non-active points	Acupuncture	Patients in this group will receive acupuncture, but in non-active points

Primary Outcome Measures

Name	Time	Method
Pain measured on the VAS	From day 0 to day 60 of the trial	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.
Improvement in life quality measured with the DLQI (Dermatology Life Quality Index)	From day 0 to day 60 of the study period	On day 0, 30 and 60 the patients will fill out a simple questionnaire with 10 questions concerning their life quality

Secondary Outcome Measures

Name	Time	Method
Approvement in skin lesions	From day 0 to day 60 of the study period	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?

Trial Locations

Locations (2)

Gentofte University hospital; 🇩🇰 Hellerup, Denmark

The departement of allergy and dermatology, Gentofte Hospital; 🇩🇰 Hellerup, Denmark