Rheumatoid ArthritisRAhealingNCT00967395
Effect of Healing on Rheumatoid Arthritis
A study testing Healing in people with Rheumatoid Arthritis, run by Henning Bliddal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Healing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent
Who cannot join
- Not able to arrange own transport, language problems
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Healing, Sham healing
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealingOther
Also called "active healing"
Healing in our study is given be a healer "no-touch", who just has to be present in the room.
Sham healingOther
Also called "placebo healing"
Sham Healing in our study is given be a student "no-touch", who just has to be present in the room.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Healing |
| Sham healing | Sham comparator | Same design of room as with the healing, while in this case a student is behind the screen Receives: Other: Sham healing |
| Control | No intervention | Business as usual in the third arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28
Measured: 8 weeks follow-up
Secondary outcomes (1)
Colour Doppler fraction
Measured: 8 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henning Bliddal
- Sponsor type
- University, hospital or other
- Collaborators
- The IMK Foundation, The Danish Rheumatism Association, Oak Foundation
- Responsible party
- Sponsor-investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Bente Danneskiold-Samsøe, Professor, Study director, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967395
- Sponsor's protocol ID
- (KF) 01-123/04
- Other IDs
- (KF) 01-123/04
- Acronym
- RAhealing
- Status last verified
- Jan 2012
- First submitted
- 26 Aug 2009
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Healing on Rheumatoid Arthritis: a Three-arm Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00967395
- Acronym / sponsor ID
- RAhealing / (KF) 01-123/04
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Henning BliddalUniversity, hospital or other
- Collaborators
- The IMK Foundation, The Danish Rheumatism Association, Oak Foundation
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healing | Experimental | Other: Healingpatients receive healing while blindfolded and with hearing protector. The healer is behind a screen and not allowed to speak with the subject. |
| Sham healing | Sham comparator | Other: Sham healingSame design of room as with the healing, while in this case a student is behind the screen |
| Control | No intervention | –Business as usual in the third arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent
Key exclusion criteria (1 listed)
- Not able to arrange own transport, language problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealingAlso: "active healing"Healing in our study is given be a healer "no-touch", who just has to be present in the room. | Other | Healing |
| Sham healingAlso: "placebo healing"Sham Healing in our study is given be a student "no-touch", who just has to be present in the room. | Other | Sham healing |
Primary outcome
DAS28
Time frame: 8 weeks follow-up
1 secondary outcome
Colour Doppler fraction
Time frame: 8 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente Danneskiold-Samsøe, Professor study director
Frederiksberg University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Healing in people with Rheumatoid Arthritis, run by Henning Bliddal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28 (time frame: 8 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.