Ignite Creation Date:
2024-05-06 @ 3:07 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02202070
Status:
WITHDRAWN
Last Update Posted:
2018-01-23
First Post:
2014-07-22
Brief Title:
Botox for Treatment of TMJ Disorder With Bruxism
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Phase 1 Study of Role of Botox in Myofascial Temporomandibular Disorder
Status:
WITHDRAWN
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMJ
Brief Summary:
Hypothesis Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm
This study will examine the use of onabotulinumtoxinA Botox to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder TMD in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up
The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism By the time patients reach the specialists office most have failed maximal conservative therapies including non-chew diet night guard oral analgesics muscle relaxants physical therapy and a portion have even undergone more invasive procedures such as manipulation under anesthesia arthroscopy and arthroplasty surgeries with limited improvement or recurrence Primary outcome of the study will be 50 reduction in pain Secondary outcomes will be 50 reduction in surgical therapy 25 increase in maximal inter-incisal opening MIO The investigators look forward to working with you on the proposed study
This study will examine the use of onabotulinumtoxinA Botox to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder TMD in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up
The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism By the time patients reach the specialists office most have failed maximal conservative therapies including non-chew diet night guard oral analgesics muscle relaxants physical therapy and a portion have even undergone more invasive procedures such as manipulation under anesthesia arthroscopy and arthroplasty surgeries with limited improvement or recurrence Primary outcome of the study will be 50 reduction in pain Secondary outcomes will be 50 reduction in surgical therapy 25 increase in maximal inter-incisal opening MIO The investigators look forward to working with you on the proposed study
Detailed Description:
The study will enroll 32 patients with myofascial TMD Patient will be aged 18-65 Exclusion criteria will include neuromuscular diseases prior botox injections within previous 12 months pregnancy and fibromyalgia All patients will be selected from the outpatient clinic complaining of TMJ disease associated with bruxism Screening will include a thorough history and exam and TMJ CT scan or MRI Patients with neuromuscular disorders musculoskeletal disorders and prior Botox injections will be excluded Patients who have not already undergone conservative treatment will be managed with 3 months conservative therapies prior to becoming eligible All patients will be informed and consented for participation in the study and Botox injections Baseline pain questionnaire physical exam will be performed Patients will be randomized to receive normal saline or botox injections All patients will crossover for the second set of injections at 3 months All patients will receive up to a total of 200 Botox units at either 0 or 3 month time points In this regard patients will act as their own placebo control Botox will be prepared according to the manufacturers instructions Briefly the lyophilized protein will be reconstituted with preservative-free normal saline and drawn into 1-mL syringe While the patient is sitting in the office procedure chair 25 to 50 U of Botox will be injected into each temporalis muscle and 25 to 50 U of Botox will be injected into the each masseter muscle The patient will be instructed to keep head elevated for 8 hours Patients will be called 3 times after the first round of injections to monitor for adverse events Patients will be seen in clinic at 3 months and asked to fill out a second pain questionnaire They will also undergo second physical exam and then receive a second set of injections crossover Patients will be seen in clinic at 6 months and asked to fill out a third pain questionnaire undergo third physical exam Patients will be called 3 times after the second round of injections to monitor for adverse events Patients will be seen in clinic at 6 months and asked to fill out a third pain questionnaire undergo a third physical exam
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