Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Pain measured on the VAS
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Acupuncture in active points
Patients in this group will receive real acupuncture
Intervention: Acupuncture (Other)
Acupuncture in non-active points
Patients in this group will receive acupuncture, but in non-active points
Intervention: Acupuncture (Other)
No treatment, just observation
Patients in this group will receive no treatment and will only be observed.
Outcomes
Primary Outcomes
Pain measured on the VAS
Time Frame: 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)
Time Frame: 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 Outcomes
- Approvement in skin lesions(From day 0 to day 60 of the study period)
Investigators
Annesofie Faurschou
MD, PhD
University Hospital, Gentofte, Copenhagen