Effect of Healing on Rheumatoid Arthritis (RAhealing)

January 5, 2012 updated by: Henning Bliddal

Effect of Healing on Rheumatoid Arthritis: a Three-arm Double-blind, Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • "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 Names:
  • "placebo healing"
NO_INTERVENTION: Control
Business as usual in the third arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DAS28
Time Frame: 8 weeks follow-up
8 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Colour Doppler fraction
Time Frame: 8 weeks follow-up
8 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henning Bliddal

Collaborators

Oak Foundation
The Danish Rheumatism Association
The IMK Foundation

Investigators

  • Study Director: Bente Danneskiold-Samsøe, Professor, Frederiksberg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (ESTIMATE)

August 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 5, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (KF) 01-123/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Healing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe