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Effect of Healing on Rheumatoid Arthritis (RAhealing)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healing
Sham healing
Sponsored by
Henning Bliddal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    No Intervention

    Arm Label

    Healing

    Sham healing

    Control

    Arm Description

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

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

    Business as usual in the third arm

    Outcomes

    Primary Outcome Measures

    DAS28

    Secondary Outcome Measures

    Colour Doppler fraction

    Full Information

    First Posted
    August 26, 2009
    Last Updated
    January 5, 2012
    Sponsor
    Henning Bliddal
    Collaborators
    The IMK Foundation, The Danish Rheumatism Association, Oak Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00967395
    Brief Title
    Effect of Healing on Rheumatoid Arthritis
    Acronym
    RAhealing
    Official Title
    Effect of Healing on Rheumatoid Arthritis: a Three-arm Double-blind, Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    September 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Henning Bliddal
    Collaborators
    The IMK Foundation, The Danish Rheumatism Association, Oak Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healing
    Arm Type
    Experimental
    Arm Description
    patients receive healing while blindfolded and with hearing protector. The healer is behind a screen and not allowed to speak with the subject.
    Arm Title
    Sham healing
    Arm Type
    Sham Comparator
    Arm Description
    Same design of room as with the healing, while in this case a student is behind the screen
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Business as usual in the third arm
    Intervention Type
    Other
    Intervention Name(s)
    Healing
    Other Intervention Name(s)
    "active healing"
    Intervention Description
    Healing in our study is given be a healer "no-touch", who just has to be present in the room.
    Intervention Type
    Other
    Intervention Name(s)
    Sham healing
    Other Intervention Name(s)
    "placebo healing"
    Intervention Description
    Sham Healing in our study is given be a student "no-touch", who just has to be present in the room.
    Primary Outcome Measure Information:
    Title
    DAS28
    Time Frame
    8 weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Colour Doppler fraction
    Time Frame
    8 weeks follow-up

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bente Danneskiold-Samsøe, Professor
    Organizational Affiliation
    Frederiksberg University Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Healing on Rheumatoid Arthritis

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