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

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ClinicalTrials.gov Identifier: NCT02047851
Recruitment Status : Terminated (Not enough study participants, difficulties in recruitment)
First Posted : January 28, 2014
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
Aage Bangs Fond
Information provided by (Responsible Party):
Annesofie Faurschou, 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

Condition or disease Intervention/treatment Phase
Psoriasis Arthralgia Other: Acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
Study Start Date : October 2014
Actual Primary Completion Date : May 9, 2018
Actual Study Completion Date : May 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Acupuncture in active points
Patients in this group will receive real acupuncture
Other: 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
Other: Acupuncture
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.



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047851


Locations
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Denmark
Gentofte University hospital
Hellerup, Denmark, 2900
The departement of allergy and dermatology, Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Aage Bangs Fond
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Responsible Party: Annesofie Faurschou, MD, PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02047851    
Other Study ID Numbers: H-1-2013-122
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Arthralgia
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations