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

NCT02047851 | Terminated DMC

• 1 other identifier: H-1-2013-122
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Psoriasis; Arthralgia

Outcome Measures

Primary Outcomes (2)

• Pain measured on the VAS

  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)

  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 Outcomes (1)

• Approvement in skin lesions

  From day 0 to day 60 of the study period

Study Arms (3)

Acupuncture in active points

ACTIVE COMPARATOR

Patients in this group will receive real acupuncture

Other: Acupuncture

Acupuncture in non-active points

SHAM COMPARATOR

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

Other: Acupuncture

No treatment, just observation

NO INTERVENTION

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

Interventions

Acupuncture OTHER

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

Acupuncture in active points; Acupuncture in non-active points

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Aage Bangs Fond: collaborator

Study Sites (2)

Gentofte University hospital

Hellerup, 2900, Denmark

Location

The departement of allergy and dermatology, Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Psoriasis; Arthralgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: January 28, 2014
• Study Start: October 1, 2014
• Primary Completion: May 9, 2018
• Study Completion: May 9, 2018
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

DK (2)