PsoriasisNCT02047851
Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
A study testing Acupuncture in people with Psoriasis and Arthralgia, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine whether acupuncture is helpful for patients with joint pain associated with psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Arthralgia
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2014to 9 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Gentofte University hospital
Hellerup, 2900
The departement of allergy and dermatology, Gentofte Hospital
Hellerup, 2900
About this study
The purpose of this study is to determine whether acupuncture is helpful for patients with joint pain associated with psoriasis
Read the 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.
- Conditions
- Psoriasis, Arthralgia
- Being tested
- Acupuncture
- Medical subject headings
- Psoriasis, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture in active points | Active comparator | Patients in this group will receive real acupuncture Receives: Other: Acupuncture |
| Acupuncture in non-active points | Sham comparator | Patients in this group will receive acupuncture, but in non-active points Receives: Other: Acupuncture |
| No treatment, just observation | No intervention | Patients in this group will receive no treatment and will only be observed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From day 0 to day 60 of the study period
Secondary outcomes (1)
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?
Measured: From day 0 to day 60 of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startOct 2014
- Primary completion9 May 2018
- Study completion9 May 2018
Why it stopped: Not enough study participants, difficulties in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aage Bangs Fond
- Responsible party
- Principal investigator, Annesofie Faurschou, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047851
- Sponsor's protocol ID
- H-1-2013-122
- Status last verified
- Oct 2019
- First submitted
- 26 Jan 2014
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT02047851
- Acronym / sponsor ID
- H-1-2013-122
- Conditions
- Psoriasis, Arthralgia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough study participants, difficulties in recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Aage Bangs Fond
- Study start
- Oct 2014
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture in active points | Active comparator | Other: AcupuncturePatients in this group will receive real acupuncture |
| Acupuncture in non-active points | Sham comparator | Other: AcupuncturePatients in this group will receive acupuncture, but in non-active points |
| No treatment, just observation | No intervention | –Patients in this group will receive no treatment and will only be observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupuncturePatients are randomized to real acupuncture or sham acupuncture if they are in the intervention group | Other | Acupuncture in active points, Acupuncture in non-active points |
Primary outcome
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.
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
1 secondary outcome
Approvement in skin lesions
Time frame: From day 0 to day 60 of the study period
Results and safety
The study was stopped early (reason given: Not enough study participants, difficulties in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Psoriasis and Arthralgia, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough study participants, difficulties in recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured on the VAS (time frame: From day 0 to day 60 of the trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.