Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602375
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals with Temporomandibular Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals with Temporomandibular Disorders a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized clinical trial among US military active-duty service-members with temporomandibular disorders TMD is to determine whether standard care plus 6-weeks of tailored individualized physical therapy PT treatment provides greater benefit than standard care alone in patient-reported outcomes and maximal mouth opening
The aims of the study are to compare outcomes in individuals with TMD that receive standard care treatment versus standard care plus PT interventions at 0- 6- and 12-weeks The investigators anticipate that subjects in the standard care plus PT group will exhibit improved patient-reported outcomes and maximal mouth opening compared to those who received standard care alone
Additionally the investigators will compare the amount and type of healthcare utilization between the two groups Standard Care and Standard Care PT in the 12-month period following enrollment in the study
All participants will be managed by their primary dental provider and receive care as deemed appropriate by their provider All participants will complete patient-reported outcome measures and have their jaw motion measured Those randomized to the standard care plus PT group will also receive a tailored PT evaluation followed by an individualized plan of care two times per week for up to six weeks
The aims of the study are to compare outcomes in individuals with TMD that receive standard care treatment versus standard care plus PT interventions at 0- 6- and 12-weeks The investigators anticipate that subjects in the standard care plus PT group will exhibit improved patient-reported outcomes and maximal mouth opening compared to those who received standard care alone
Additionally the investigators will compare the amount and type of healthcare utilization between the two groups Standard Care and Standard Care PT in the 12-month period following enrollment in the study
All participants will be managed by their primary dental provider and receive care as deemed appropriate by their provider All participants will complete patient-reported outcome measures and have their jaw motion measured Those randomized to the standard care plus PT group will also receive a tailored PT evaluation followed by an individualized plan of care two times per week for up to six weeks
Detailed Description:
The following procedures will be conducted once the subject has signed and received their informed consent and Health Insurance Portability and Accountability Act HIPAA documents
Inclusionexclusion will be reviewed including the TMD Pain Screener Subjects will then be provided with research questionnaires and patient-reported outcome measures for completion All outcomes will be obtained through direct interaction with subjects
Subjects will then undergo measurements for pain-free mouth opening and maximal mouth opening MMO ranges of motion All subjects will undergo the same measurement protocol
Following the above measures subjects will then be randomized into one of two parallel treatment arms standard care control group or standard care PT interventions experimental group The groups are further described below The method of group assignment will be sequentially numbered opaque sealed envelopes SNOSE To minimize the risk of predicting the treatment assignment of the next eligible subject randomization will be performed in permuted blocks of 2 or 4 with random variation of the blocking number Due to the nature of the study it is not possible to blind the subjects or the clinician providing the intervention to the treatment received Assessors will be blinded to group allocation and clinicians will be blinded to outcomes
After randomization enrolled subjects who have already received care from a dental provider will continue with their dental provider for routine TMD care Any enrolled subjects not being seen by a dental provider for their TMD concerns will be referred to the prosthodontist associated with this study
These enrollment procedures may last up to one hour
Those randomized to the standard care control group will follow the plan of care determined by their treating dental provider This group will receive standard routine care from the dental provider for the treatment of TMD These decisions will be based on the clinical judgment of the dental provider as is customary with routine care for TMD
Participants randomized to the standard care PT interventions experimental group will receive standard care from their treating dental provider In addition they will receive routine physical therapy interventions over a 6-week - 2 week period Study participants will receive treatment based on their clinical examination as is typical for routine physical therapy clinical practice Subjects will attend up to 12 sessions over 6-weeks - 2 weeks as is typical for physical therapy management of TMD conditions The initial physical therapy visit will be 60-minutes long with all subsequent appointments being 30-minutes to include any booster sessions
The interventions will be pragmatic in nature with provided treatment being specific to the subjects specific complaints goals and examination identified impairments as is customary for physical therapist management of TMD conditions Physical therapists will progress the program at the rate perceived to be most efficacious for the participants needs All PT interventions utilized in this study are considered routine care for individuals with TMD
This study is intentionally pragmatic in that study participants will receive treatment as they are comfortable and as recommended by the treating providers For example it is not expected that every patient receives cervical spine mobilizations during physical therapy however in some of the participants this may be needed to aid in beneficial treatment Similarly dental providers are not required to provide splinting or medications to all participants Provided treatment will be based on providers clinical reasoning as it customary
Both groups will have follow-up outcomes collected at 6-weeks - 3 days following study enrollment All outcomes will be obtained through direct interaction with subjects
Between the 6- and 12-week data collection appointments all subjects may continue with standard care interventions and processes as indicated and recommended by the overseeing dental provider Subjects assigned to the experimental group will have the option of booster treatment sessions with one of the research team members Booster sessions refer to the subject choosing to attend more appointments after their course of care has been completed should their symptoms return In this case booster sessions would be available between the 6 and 12-week follow-up time points Booster sessions will be limited to two sessions as is typical with physical therapy practice Booster sessions will last 30-minutes and are routinely offered for patients at the participating Physical Therapy Clinic as part of typical clinical practice for physical therapy management of musculoskeletal conditions
Both groups will have follow-up outcomes collected at 12-weeks - 3 days following study enrollment
Subjects enrolled in the standard care only group who are not satisfied with their clinical progress will be offered physical therapy services at this time This care will be unrelated to study aim 1 of this research and no additional data collection will occur
Healthcare utilization data will be collected from the Military Health System Data Repository MDR database and will be confirmed via electronic health record system review Healthcare utilization data will be used to determine any subsequent medical utilization related to TMD To collect this information a Data Sharing Agreement DSA will be completed between the research team and the Defense Health Agency DHA A signed completed IRB protocol is required prior to submitting the DSA However this should not impact the timing of this study as the data pull will be completed after the last enrolled subjectamp39s final follow-up at 12-weeks post-enrollment This will provide enough time to complete the data sharing agreement DSA with both agencies before performing this analysis Details for determining the health care utilization are outlined below
The goal of the MDR database will be to determine which of these subjects sought health care related to TMD in the 12-month period after treatment in this study This data will allow us to determine the extent of healthcare utilization incidence in both groups
Recording of Extracted Data with Identifiers The data will be provided in a coded manner from the data analysts These analysts are Defense Health Agency DHA employees with full authorized access to these Department of Defense DoD databases They must have a signed Data Sharing Agreement from the Privacy Board of the DHA to pull the requested data They have full authorization to access and pull this data as they do this regularly for business operations and operational decision making by leaders at the DHA As they have done before with members of our team on prior projects they extract all the required data based upon the name age and DoD identification number that the Research Team provides to the analyst to identify the correct subjects that were in the study Investigators will see the provided PII via secure safe AMRDC or encrypted government email as they need this for the extraction However they will replace everything with a pseudo identification number that aligns with the study subject ID before returning the coded de-identified data back to the research team for analysis Before any personal identifying information PII is released each research subject will authorize the release through a signed HIPAA Authorization Document The analyst will also assign a pseudo identification number matched with the list of our subject PHI that the investigators provided to them Therefore the final working set they provide us for analysis will not have any identifying PHIPII associated with it If additional follow-up is needed to clarify a health care utilization event in MHS GENESIS the research team can check the master subject record stored by the PI on an encrypted computer to link the pseudo identification number to DOD ID Therefore prior to analysis occurring only files with coded identifiers will be used Confidentiality of protected health information will always be maintained by the PI The final working database to be used in the data analysis will not include PHI information
Location of Extracted and Recorded Data The health care utilization data will be extracted from the MDR database Even though the data is now coded the extracted data will still be maintained in an encrypted password protected file kept at the participating physical therapy clinic Brooke Army Medical Center by the PI All data collection forms and the master participant list will be secured in an office at the participating physical therapy clinic All data maintained on a computer will be password protected and only accessible by the study investigators
Nature of Identifying Data Timeframes will be requested in reference to the baseline enrollment date rather than the actual date of the visit For example the date of appointment will be required initially to determine when the healthcare visit associated with the TMD occurred However this data will be coded differently in the working spreadsheet Data will be returned with the days from the index date enrollment listed rather than a date For example a subject was enrolled on 1 Jun 2024 and then had a medical visit of interest on 15 July 2024 The encounter will be 45 as an indicator of the visit occurring 45 days after enrollment Analysis of the data will only occur in the coded spreadsheet that will not have dates
Status of the extracted data after completion of the research study At the study completion the Master Key file linking the participants PII to the study will be deleted The PI will then provide an electronic copy of the most current version of the protocol IRB approval letter final report signed HIPAA Authorizations and the most current version of the ICD for indefinite archiving The PI will submit a copy of all ICD signature pages as well An electronic copy of all signed HIPAAs and ICDs will be provided to the Protocol Office during each Progress Report submittal After at least six years the data will be destroyed in accordance with research department protocol Full compliance with Health Insurance Portability and Accountability Act HIPAA standards will be upheld throughout the investigation to protect confidentiality
Inclusionexclusion will be reviewed including the TMD Pain Screener Subjects will then be provided with research questionnaires and patient-reported outcome measures for completion All outcomes will be obtained through direct interaction with subjects
Subjects will then undergo measurements for pain-free mouth opening and maximal mouth opening MMO ranges of motion All subjects will undergo the same measurement protocol
Following the above measures subjects will then be randomized into one of two parallel treatment arms standard care control group or standard care PT interventions experimental group The groups are further described below The method of group assignment will be sequentially numbered opaque sealed envelopes SNOSE To minimize the risk of predicting the treatment assignment of the next eligible subject randomization will be performed in permuted blocks of 2 or 4 with random variation of the blocking number Due to the nature of the study it is not possible to blind the subjects or the clinician providing the intervention to the treatment received Assessors will be blinded to group allocation and clinicians will be blinded to outcomes
After randomization enrolled subjects who have already received care from a dental provider will continue with their dental provider for routine TMD care Any enrolled subjects not being seen by a dental provider for their TMD concerns will be referred to the prosthodontist associated with this study
These enrollment procedures may last up to one hour
Those randomized to the standard care control group will follow the plan of care determined by their treating dental provider This group will receive standard routine care from the dental provider for the treatment of TMD These decisions will be based on the clinical judgment of the dental provider as is customary with routine care for TMD
Participants randomized to the standard care PT interventions experimental group will receive standard care from their treating dental provider In addition they will receive routine physical therapy interventions over a 6-week - 2 week period Study participants will receive treatment based on their clinical examination as is typical for routine physical therapy clinical practice Subjects will attend up to 12 sessions over 6-weeks - 2 weeks as is typical for physical therapy management of TMD conditions The initial physical therapy visit will be 60-minutes long with all subsequent appointments being 30-minutes to include any booster sessions
The interventions will be pragmatic in nature with provided treatment being specific to the subjects specific complaints goals and examination identified impairments as is customary for physical therapist management of TMD conditions Physical therapists will progress the program at the rate perceived to be most efficacious for the participants needs All PT interventions utilized in this study are considered routine care for individuals with TMD
This study is intentionally pragmatic in that study participants will receive treatment as they are comfortable and as recommended by the treating providers For example it is not expected that every patient receives cervical spine mobilizations during physical therapy however in some of the participants this may be needed to aid in beneficial treatment Similarly dental providers are not required to provide splinting or medications to all participants Provided treatment will be based on providers clinical reasoning as it customary
Both groups will have follow-up outcomes collected at 6-weeks - 3 days following study enrollment All outcomes will be obtained through direct interaction with subjects
Between the 6- and 12-week data collection appointments all subjects may continue with standard care interventions and processes as indicated and recommended by the overseeing dental provider Subjects assigned to the experimental group will have the option of booster treatment sessions with one of the research team members Booster sessions refer to the subject choosing to attend more appointments after their course of care has been completed should their symptoms return In this case booster sessions would be available between the 6 and 12-week follow-up time points Booster sessions will be limited to two sessions as is typical with physical therapy practice Booster sessions will last 30-minutes and are routinely offered for patients at the participating Physical Therapy Clinic as part of typical clinical practice for physical therapy management of musculoskeletal conditions
Both groups will have follow-up outcomes collected at 12-weeks - 3 days following study enrollment
Subjects enrolled in the standard care only group who are not satisfied with their clinical progress will be offered physical therapy services at this time This care will be unrelated to study aim 1 of this research and no additional data collection will occur
Healthcare utilization data will be collected from the Military Health System Data Repository MDR database and will be confirmed via electronic health record system review Healthcare utilization data will be used to determine any subsequent medical utilization related to TMD To collect this information a Data Sharing Agreement DSA will be completed between the research team and the Defense Health Agency DHA A signed completed IRB protocol is required prior to submitting the DSA However this should not impact the timing of this study as the data pull will be completed after the last enrolled subjectamp39s final follow-up at 12-weeks post-enrollment This will provide enough time to complete the data sharing agreement DSA with both agencies before performing this analysis Details for determining the health care utilization are outlined below
The goal of the MDR database will be to determine which of these subjects sought health care related to TMD in the 12-month period after treatment in this study This data will allow us to determine the extent of healthcare utilization incidence in both groups
Recording of Extracted Data with Identifiers The data will be provided in a coded manner from the data analysts These analysts are Defense Health Agency DHA employees with full authorized access to these Department of Defense DoD databases They must have a signed Data Sharing Agreement from the Privacy Board of the DHA to pull the requested data They have full authorization to access and pull this data as they do this regularly for business operations and operational decision making by leaders at the DHA As they have done before with members of our team on prior projects they extract all the required data based upon the name age and DoD identification number that the Research Team provides to the analyst to identify the correct subjects that were in the study Investigators will see the provided PII via secure safe AMRDC or encrypted government email as they need this for the extraction However they will replace everything with a pseudo identification number that aligns with the study subject ID before returning the coded de-identified data back to the research team for analysis Before any personal identifying information PII is released each research subject will authorize the release through a signed HIPAA Authorization Document The analyst will also assign a pseudo identification number matched with the list of our subject PHI that the investigators provided to them Therefore the final working set they provide us for analysis will not have any identifying PHIPII associated with it If additional follow-up is needed to clarify a health care utilization event in MHS GENESIS the research team can check the master subject record stored by the PI on an encrypted computer to link the pseudo identification number to DOD ID Therefore prior to analysis occurring only files with coded identifiers will be used Confidentiality of protected health information will always be maintained by the PI The final working database to be used in the data analysis will not include PHI information
Location of Extracted and Recorded Data The health care utilization data will be extracted from the MDR database Even though the data is now coded the extracted data will still be maintained in an encrypted password protected file kept at the participating physical therapy clinic Brooke Army Medical Center by the PI All data collection forms and the master participant list will be secured in an office at the participating physical therapy clinic All data maintained on a computer will be password protected and only accessible by the study investigators
Nature of Identifying Data Timeframes will be requested in reference to the baseline enrollment date rather than the actual date of the visit For example the date of appointment will be required initially to determine when the healthcare visit associated with the TMD occurred However this data will be coded differently in the working spreadsheet Data will be returned with the days from the index date enrollment listed rather than a date For example a subject was enrolled on 1 Jun 2024 and then had a medical visit of interest on 15 July 2024 The encounter will be 45 as an indicator of the visit occurring 45 days after enrollment Analysis of the data will only occur in the coded spreadsheet that will not have dates
Status of the extracted data after completion of the research study At the study completion the Master Key file linking the participants PII to the study will be deleted The PI will then provide an electronic copy of the most current version of the protocol IRB approval letter final report signed HIPAA Authorizations and the most current version of the ICD for indefinite archiving The PI will submit a copy of all ICD signature pages as well An electronic copy of all signed HIPAAs and ICDs will be provided to the Protocol Office during each Progress Report submittal After at least six years the data will be destroyed in accordance with research department protocol Full compliance with Health Insurance Portability and Accountability Act HIPAA standards will be upheld throughout the investigation to protect confidentiality
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