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Effect of Healing on Rheumatoid Arthritis (RAhealing)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00967395
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : January 6, 2012
Sponsor:
Collaborators:
The IMK Foundation
The Danish Rheumatism Association
Oak Foundation
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Healing Other: Sham healing Not Applicable

Detailed Description:
The central claim of healers is that this process facilitates self-healing in the patient. Spiritual healing includes several categories, including 'therapeutic touch' and 'intercessory prayer', and the healing may be attributed to God, spirits, universal forces or energies, biological healing energies residing in the healer, or self-healing powers or energies thought to reside latent in the healed organism. The highly controversial hypothesized effects of distant or spiritual healing contradict our traditional sense of reality and are in conflict with what is generally viewed as being in correspondence with modern science.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of Healing on Rheumatoid Arthritis: a Three-arm Double-blind, Randomized, Controlled Trial
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Healing
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
Healing in our study is given be a healer "no-touch", who just has to be present in the room.
Other Name: "active healing"
Sham Comparator: Sham healing
Same design of room as with the healing, while in this case a student is behind the screen
 Other: Sham healing
Sham Healing in our study is given be a student "no-touch", who just has to be present in the room.
Other Name: "placebo healing"
No Intervention: Control
Business as usual in the third arm


Outcome Measures
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Primary Outcome Measures :
  1. DAS28 [ Time Frame: 8 weeks follow-up ]

Secondary Outcome Measures :
  1. Colour Doppler fraction [ Time Frame: 8 weeks follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to arrange own transport, language problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967395


Sponsors and Collaborators
Henning Bliddal
The IMK Foundation
The Danish Rheumatism Association
Oak Foundation
Investigators
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Study Director: Bente Danneskiold-Samsøe, Professor Frederiksberg University Hospital
More Information
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Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00967395    
Other Study ID Numbers: (KF) 01-123/04
(KF) 01-123/04
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases