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

NCT ID: NCT02047851

Last Updated: 2019-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-05-09

Brief Summary

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

Detailed Description

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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.

Conditions

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Psoriasis Arthralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acupuncture in active points

Patients in this group will receive real acupuncture

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group

Acupuncture in non-active points

Patients in this group will receive acupuncture, but in non-active points

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type OTHER

Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group

No treatment, just observation

Patients in this group will receive no treatment and will only be observed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aage Bangs Fond

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Annesofie Faurschou

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gentofte University hospital

Hellerup, , Denmark

Site Status

The departement of allergy and dermatology, Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-1-2013-122

Identifier Type: -

Identifier Source: org_study_id

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