Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009594
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-02-01
Brief Title:
Alternative Medicine Approaches for Women With Temporomandibular Disorders
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Alternative Medicine Approaches for Women With Temporomandibular Disorders
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Temporomandibular disorders TMD are characterized by pain and tenderness in the muscles of mastication andor the temporomandibular joint TMJ limitations of jaw opening often accompanied by deviations in mandibular path and clicking popping or grating TMJ sounds
TMD is often found in association with other problems depression anxiety sleep disturbances gastrointestinal symptoms frequent infections etc This project proposes to holistically address patient symptoms through three different approaches Naturopathic Medicine NM Traditional Chinese Medicine TCM and usual care at KPNW We will conduct a pilot test and Phase II trial to evaluate the two alternative healing approaches TCM n50 and NM n50 delivered by TCM and NM practitioners are as effective as usual TMD care n50 provided by dental clinicians in the KPNW TMD Clinic Subjects will be females 25-55 years of age with multiple health problems defined as patients who have had at least 4 organ system-grouped diagnoses in the past year not including TMD Subjects will be evaluated at baseline 6 and 12 months after start of treatment The primary endpoint is change from baseline in the Axis II Pain Related Disability and Psychological Status Scale Clinical examinations saliva samples to assess salivary cortisol levels and responses to a series of questionnaires to assess pain chronic pain psychosocial functioning and other physical symptoms will be used to assess outcomes We will passively monitor health care utilization within KPNW using clinical research and administrative databases to determine whether the interventions have an impact on overall health care utilization If either of these alternative interventions is shown to merit Phase III trial our goal is to design and implement such a clinical trial to further evaluate the health consequences and costs of these alternative healing paradigms
TMD is often found in association with other problems depression anxiety sleep disturbances gastrointestinal symptoms frequent infections etc This project proposes to holistically address patient symptoms through three different approaches Naturopathic Medicine NM Traditional Chinese Medicine TCM and usual care at KPNW We will conduct a pilot test and Phase II trial to evaluate the two alternative healing approaches TCM n50 and NM n50 delivered by TCM and NM practitioners are as effective as usual TMD care n50 provided by dental clinicians in the KPNW TMD Clinic Subjects will be females 25-55 years of age with multiple health problems defined as patients who have had at least 4 organ system-grouped diagnoses in the past year not including TMD Subjects will be evaluated at baseline 6 and 12 months after start of treatment The primary endpoint is change from baseline in the Axis II Pain Related Disability and Psychological Status Scale Clinical examinations saliva samples to assess salivary cortisol levels and responses to a series of questionnaires to assess pain chronic pain psychosocial functioning and other physical symptoms will be used to assess outcomes We will passively monitor health care utilization within KPNW using clinical research and administrative databases to determine whether the interventions have an impact on overall health care utilization If either of these alternative interventions is shown to merit Phase III trial our goal is to design and implement such a clinical trial to further evaluate the health consequences and costs of these alternative healing paradigms
Detailed Description:
See brief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50AT000076-01 | NIH | None | httpsreporternihgovquickSearchP50AT000076-01 |