search
Back to results

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

Primary Purpose

Psoriasis, Arthralgia

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gentofte University hospital
  • The departement of allergy and dermatology, Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

No Intervention

Arm Label

Acupuncture in active points

Acupuncture in non-active points

No treatment, just observation

Arm Description

Patients in this group will receive real acupuncture

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

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Approvement in skin lesions
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?

Full Information

First Posted
January 26, 2014
Last Updated
October 14, 2019
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Aage Bangs Fond
search

1. Study Identification

Unique Protocol Identification Number
NCT02047851
Brief Title
Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
Official Title
Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Not enough study participants, difficulties in recruitment
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 9, 2018 (Actual)
Study Completion Date
May 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Aage Bangs Fond

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Arthralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture in active points
Arm Type
Active Comparator
Arm Description
Patients in this group will receive real acupuncture
Arm Title
Acupuncture in non-active points
Arm Type
Sham Comparator
Arm Description
Patients in this group will receive acupuncture, but in non-active points
Arm Title
No treatment, just observation
Arm Type
No Intervention
Arm Description
Patients in this group will receive no treatment and will only be observed.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group
Primary Outcome Measure Information:
Title
Pain measured on the VAS
Description
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.
Time Frame
From day 0 to day 60 of the trial
Title
Improvement in life quality measured with the DLQI (Dermatology Life Quality Index)
Description
On day 0, 30 and 60 the patients will fill out a simple questionnaire with 10 questions concerning their life quality
Time Frame
From day 0 to day 60 of the study period
Secondary Outcome Measure Information:
Title
Approvement in skin lesions
Description
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?
Time Frame
From day 0 to day 60 of the study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Gentofte University hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
The departement of allergy and dermatology, Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs