Temporomandibular DisordersPhase 1NCT00071474
Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)
A Phase 1 study of Temporomandibular Disorders, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing for treating temporomandibular joint disorders (TMDs). Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to May 2005
- Phase
- Phase 1
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females Age 25-55
- TMD Research Diagnosis Criteria (RDC) clinical diagnosis of myofacial pain with or without disc displacement, arthralgia, arthritis, or arthosis
- Three or more significant systemic conditions, e.g. depression, fibromyalgia, GI or reproductive disturbances, upper respiratory problems, etc. in the preceding 2 years.
Who cannot join
- Diagnosed organic or medication induced major mental illness (e.g., schizophrenia, bipolar)
- Other neurological diagnoses (epilepsy, Parkinsons)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Health Research, Northwest
Portland, Oregon
About this study
This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing for treating temporomandibular joint disorders (TMDs).
Read the detailed description
Traditional systems of healing, such as shamanism, do not readily lend themselves to conventional research methods, yet studying their effectiveness is especially germane in the case of chronic conditions that involve an emotional component and that elude allopathic treatment regimens. Temporomandibular joint disorders (TMDs), which affect up to 10% of the adult population, are a prime example of such conditions. Traditional treatment outcomes for TMD pain are often unsatisfactory. Moreover, in women age 25-55 (the age-sex group most affected), TMD is often found in association with depression, anxiety, sleep disturbances, gastrointestinal symptoms, frequent infection,and fibromyalgia. Because these multiple and complex symptoms suggest a loss of spirit or life energy, they may be particularly susceptible to treatment by shamanic (spiritual) healing, which aims to bring disturbed physical, mental, and emotional systems into balance. This phase I study will develop methods to evaluate shamanic healing as an intervention for TMD and will evaluate the feasibility of conducting randomized clinical trials of shamanic healing.
- Conditions
- Temporomandibular Disorders
- Being tested
- shamanic healing
- Keywords
- temporomandibular disroders, shamanism, chronic pain
- Medical subject headings
- Temporomandibular Joint Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shamanic healingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2003 (estimated)
- Study startAug 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Nancy Vuckovic, MD, Principal investigator, Center for Health Research, Northwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071474
- Sponsor's protocol ID
- R21AT000951-01A2
- Status last verified
- Jan 2007
- First submitted
- 23 Oct 2003
- Last updated
- 24 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)
- ClinicalTrials.gov ID
- NCT00071474
- Acronym / sponsor ID
- R21AT000951-01A2
- Conditions
- Temporomandibular Disorders
- Keywords
- temporomandibular disroders, shamanism, chronic pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 2003
- Study completion
- May 2005
- First posted
- 24 Oct 2003 (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.
This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing for treating temporomandibular joint disorders (TMDs).
Detailed description
Traditional systems of healing, such as shamanism, do not readily lend themselves to conventional research methods, yet studying their effectiveness is especially germane in the case of chronic conditions that involve an emotional component and that elude allopathic treatment regimens. Temporomandibular joint disorders (TMDs), which affect up to 10% of the adult population, are a prime example of such conditions. Traditional treatment outcomes for TMD pain are often unsatisfactory. Moreover, in women age 25-55 (the age-sex group most affected), TMD is often found in association with depression, anxiety, sleep disturbances, gastrointestinal symptoms, frequent infection,and fibromyalgia. Because these multiple and complex symptoms suggest a loss of spirit or life energy, they may be particularly susceptible to treatment by shamanic (spiritual) healing, which aims to bring disturbed physical, mental, and emotional systems into balance. This phase I study will develop methods to evaluate shamanic healing as an intervention for TMD and will evaluate the feasibility of conducting randomized clinical trials of shamanic healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females Age 25-55
- TMD Research Diagnosis Criteria (RDC) clinical diagnosis of myofacial pain with or without disc displacement, arthralgia, arthritis, or arthosis
- Three or more significant systemic conditions, e.g. depression, fibromyalgia, GI or reproductive disturbances, upper respiratory problems, etc. in the preceding 2 years.
Key exclusion criteria (3 listed)
- Diagnosed organic or medication induced major mental illness (e.g., schizophrenia, bipolar)
- Other neurological diagnoses (epilepsy, Parkinsons)
- Pregnancy
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 |
|---|---|---|
| shamanic healing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 24 Jan 2007.
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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.
Nancy Vuckovic, MD principal investigator
Center for Health Research, Northwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Temporomandibular Disorders, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 3 inclusion and 3 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 24 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 24 Jan 2007.