|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 23, 2003 | ||||
| Last Updated Date | January 22, 2007 | ||||
| Start Date ICMJE | August 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00071474 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs) | ||||
| Official Title ICMJE | |||||
| Brief Summary | 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 Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||
| Condition ICMJE | Temporomandibular Disorders | ||||
| Intervention ICMJE | Procedure: shamanic healing | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | May 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
|
||||
| Gender | Female | ||||
| Ages | 25 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00071474 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R21 AT000951-01A2 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | January 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||