NCT00967395

Brief Summary

The hypothesis is that healing may influence the patient's general status by altering psychological as well as other body functions of importance for the rheumatoid arthritis. This is tested in a three group design with a control group and two groups receiving healing with or without a healer present. The study is randomized and double blind.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

August 26, 2009

Last Update Submit

January 5, 2012

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • DAS28

    8 weeks follow-up

Secondary Outcomes (1)

  • Colour Doppler fraction

    8 weeks follow-up

Study Arms (3)

Healing

EXPERIMENTAL

patients receive healing while blindfolded and with hearing protector. The healer is behind a screen and not allowed to speak with the subject.

Other: Healing

Sham healing

SHAM COMPARATOR

Same design of room as with the healing, while in this case a student is behind the screen

Other: Sham healing

Control

NO INTERVENTION

Business as usual in the third arm

Interventions

HealingOTHER

Healing in our study is given be a healer "no-touch", who just has to be present in the room.

Also known as: "active healing"
Healing
Sham healingOTHER

Sham Healing in our study is given be a student "no-touch", who just has to be present in the room.

Also known as: "placebo healing"
Sham healing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent

You may not qualify if:

  • Not able to arrange own transport, language problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bente Danneskiold-Samsøe, Professor

    Frederiksberg University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

September 1, 2009

Last Updated

January 6, 2012

Record last verified: 2012-01