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

October 14, 2019 updated by: Annesofie Faurschou, University Hospital, Gentofte, Copenhagen
The purpose of this study is to determine whether acupuncture is helpful for patients with joint pain associated with psoriasis

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hellerup, Denmark, 2900
        • Gentofte University Hospital
      • Hellerup, Denmark, 2900
        • The departement of allergy and dermatology, Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From day 0 to day 60 of the trial
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
From day 0 to day 60 of the study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Approvement in skin lesions
Time Frame: 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?
From day 0 to day 60 of the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 9, 2018

Study Completion (Actual)

May 9, 2018

Study Registration Dates

First Submitted

January 26, 2014

First Submitted That Met QC Criteria

January 26, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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