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.
Inclusion/exclusion 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 subject's 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 participant's
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 subject's 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 PHI/PII 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 participant's 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.
