Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066937
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2003-08-07
Brief Title:
Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder TMD
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Pain Management in Temporomandibular Joint Disorders
Status:
COMPLETED
Status Verified Date:
2017-07
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:
The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD
Detailed Description:
This is a randomized controlled trial evaluating pharmacological nortriptyline vs active placebo - benztropine and psychological cognitive-behavioral therapy vs disease education treatments for pain and disability due to temporomandibular joint disorder TMD Patients 18 to 65 years old meeting RDC criteria for TMD and other eligibility criteria complete a 3-week baseline monitoring phase prior to randomization Active treatment consists of weekly visits for 8 week then maintenance treatment for 6 months Outcome measures include pain physical and psychosocial function and are assessed at post-treatment 3-months and 6-months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE013906 | NIH | None | httpsreporternihgovquickSearchR01DE013906 |