Effect of Healing on Rheumatoid Arthritis (RAhealing)

This study has been completed.
Sponsor:
Collaborators:
The IMK Foundation
The Danish Rheumatism Association
Oak Foundation
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00967395
First received: August 26, 2009
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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 Intervention
Rheumatoid Arthritis
Other: Healing
Other: Sham healing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of Healing on Rheumatoid Arthritis: a Three-arm Double-blind, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • DAS28 [ Time Frame: 8 weeks follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Colour Doppler fraction [ Time Frame: 8 weeks follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967395

Sponsors and Collaborators
Henning Bliddal
The IMK Foundation
The Danish Rheumatism Association
Oak Foundation
Investigators
Study Director: Bente Danneskiold-Samsøe, Professor Frederiksberg University Hospital
  More Information

No publications provided

Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00967395     History of Changes
Other Study ID Numbers: (KF) 01-123/04, (KF) 01-123/04
Study First Received: August 26, 2009
Last Updated: January 5, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014