- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047851
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
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.
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-1-2013-122
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.
Clinical Trials on Arthralgia
-
Victoria ShanmugamCompletedArthritis | Synovitis | Arthralgia SyndromeUnited States
-
University Hospital, LilleCompleted
-
Hospital de Clinicas de Porto AlegreUnknown
-
Grant JonesGenzyme, a Sanofi CompanyWithdrawnArthralgiaUnited States
-
The Center for Applied Health Sciences, LLCNatreon, Inc.Completed
-
AHS Cancer Control AlbertaRecruitingArthritis | ArthralgiaCanada
-
AHS Cancer Control AlbertaNot yet recruitingArthritis | Arthralgia
-
Uppsala UniversityCompleted
-
Jacksonville UniversityNot yet recruiting
Clinical Trials on Acupuncture
-
Federal University of São PauloCompleted
-
University of ZurichCharite University, Berlin, Germany; First Teaching Hospital of Tianjin University...CompletedExperimental Dental PainSwitzerland
-
University of SkövdeCompleted
-
National Research Centre of Complementary and Alternative...Norwegian Acupuncture CollegeUnknown
-
Chengdu University of Traditional Chinese MedicineChongqing Medical University; Hunan University of Traditional Chinese MedicineCompletedFunctional Dyspepsia | Postprandial Distress SyndromeChina
-
Chang Gung Memorial HospitalRecruitingIntracranial HemorrhagesTaiwan
-
University Medicine GreifswaldRecruitingGagging During Transesophageal EchocardiographyGermany
-
Huazhong University of Science and TechnologyThe University of Hong Kong; Heilongjiang University of Chinese Medicine; Hubei...CompletedPolycystic Ovary SyndromeChina
-
China Medical University HospitalNot yet recruiting
-
Mike O'Callaghan Military HospitalCompleted