Conservative Treatment of Patients With Temporomandibular Disorders (D1P2-TMD)

April 17, 2017 updated by: Palmer College of Chiropractic
At any given time, 10 million Americans suffer from temporomandibular disorders (TMD), with a lifetime prevalence of 45% and costs for direct care exceeding $2 billion/year. Little evidence exists regarding the efficacy of specific conservative interventions used to treat TMD and currently there is no "gold standard" of care that is widely accepted by the dental or medical community. This study is a prospective, randomized 4 arm parallel observer-masked pilot study comparing: 1) Activator Methods Chiropractic Technique (AMCT), 2) a conservative dental approach with reversible interocclusal splint therapy, 3) a sham AMCT, and 4) a self-care only group, which includes a standard checklist of self-care jaw relaxation techniques, for a total of 80 patients with chronic myofascial TMD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All patients will be offered the self-care checklist of homecare approaches at baseline. Patients will be treated for two months with follow up at 3 and 6 months after enrollment. The primary outcome measure will be an 11 point Numerical Rating Scale for average TMD pain during the past week. Secondary outcomes will include the Oral Health Impact Profile (OHIP-14), believability of the sham AMCT compared to active AMCT, expectations of and satisfaction with care, medication use, bothersomeness of symptoms and health care utilization. Our project is a collaborative effort between the Palmer Center for Chiropractic Research (PCCR) and the University of Iowa (UI) through the College of Dentistry and the General Clinical Research Center (GCRC) Oral and Craniofacial Unit. The PCCR Clinic and Data Core will serve as the data coordinating center and will develop a web-based data collection system for this project. Patient eligibility will be assessed by dental examiners at the UI College of Dentistry using the Research Diagnostic Criteria for Temporomandibular Disorders to diagnose chronic, Axis I myofascial TMD. Dental care will be provided by a dentist at UI GCRC and chiropractic care will be provided by a private practitioner in close proximity to UI. The aims of this project are to assess the feasibility of conducting a full-scale randomized clinical trial to evaluate the effectiveness of AMCT for patients with chronic myofascial TMD; determine the most appropriate control group(s) for a full-scale randomized controlled trial; and to estimate the sample size needed for an adequately-powered trial and the recruitment period that would be required. In general, there is a lack of evidence for the efficacy of non-surgical treatment for patients with TMD, including chiropractic interventions. If the beneficial effects of the AMCT are supported in this pilot study, the logistical information gained will allow us to plan a full scale trial for patients suffering pain and disability due to TMD. It is anticipated that such a trial will allow clinicians to make more informed recommendations for treatment of patients with TMD. At the conclusion of this project, we will be well-positioned to prepare an R01 level grant application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Coralville, Iowa, United States, 52241
        • Schaeffer Chiropractic
      • Davenport, Iowa, United States, 52803
        • Palmer College of Chirpractic
      • Iowa City, Iowa, United States, 52242
        • University of Iowa College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 21 years or older
  • TMD symptoms for at least 6 months
  • Must have 7-8 teeth per dental arch that are in occlusion (can be restored teeth or dental implants with crowns or fixed dental bridgework)
  • Typical TMD pain during the past week > = 3 on an 11 point Numerical Rating Scale
  • RDC/TMD Axis I diagnosis of myofascial pain (Group Ia or Ib) with or without a concurrent diagnosis of arthralgia (Group IIIa) or disk displacement with reduction (Group IIa)
  • Stable prescription medication plan: no changes in prescription medication for pain during the past month

Exclusion Criteria:

  • Current or pending litigation for a personal injury case, worker's compensation, or disability
  • Participants with unstable periodontitis and/or a dental condition with untreated disease (e.g., caries). Participants may elect to have her/his dental care provided to stabilize their dental condition prior to randomization.
  • Subjects with Canine Class II malocclusion that would prohibit fabrication of RIST appliance
  • Cases that need further diagnostic procedures to rule in or rule out the condition (i.e., MRI or CT scan)
  • Systemic arthritis or other serious medical condition necessitating maximum daily dosing of COX-2 inhibitor or NSAIDs, (All NSAID use will be recorded in the daily diary as a part of the Self-Care data recording).
  • Participants presenting with complete dentures
  • Any treatment for TMD during the previous month, except for non-prescription medications or a stable prescription medication regimen for TMD.
  • Inability to read or verbally comprehend English
  • Unwillingness to be enrolled in any of the four intervention groups.
  • Unwillingness to postpone other forms of treatment for TMD during the two month active care phase (except for non-prescription medications or continuation of a stable prescription medication regimen).
  • Unwillingness to postpone any chiropractic care during the two month active care phase.
  • Intention to move from the area during the next seven months
  • Ever had active chiropractor care for TMD pain
  • Drug or alcohol abuse
  • Pregnant or planning to be pregnant during next seven months
  • MVA or other trauma in the last six months
  • Facial pain/TMD not worst pain
  • General poor health
  • Extensive dental work in past 6 months including orthodontics
  • Serious co-morbid conditions, including: Lupus Erythematosus, Sjogren's Syndrome, Multiple Sclerosis, Symptomatic Trigeminal Neuralgia (tic/tic douloureux) or any other neuralgia of the face, Thyroid problem not controlled by medication, Uncontrolled diabetes, Rheumatoid arthritis, Fibromyalgia, Polymyalgia Rheumatic, Giant Cell Arteritis, Psoriatic Arthritis, Reiters Syndrome, Bechets Syndrome, Crohn's Disease, Ulcerative Colitis, Parkinson's Disease, Tardive Dyskinesia, Active seizure disorder, Stroke with head and neck symptoms, Addison's Disease, Cushing's Disease
  • Have had or ever had any type of head or neck surgery within the last 6 months
  • Have had or ever had radiation treatment to the head and/or neck
  • Have had or ever had surgery of your jaw joints, not including arthroscopic surgery
  • Have had or ever had Herpes Zoster or shingles in the face

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Chiropractic w/Activator & Self Care
This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.
Device: Chiropractic w/Activator & Self Care
This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw.
Active Comparator: Dental Care & Self Care
Intraoral splints are removable orthopedic appliances fabricated of hard acrylic resin positioned between the remaining teeth of the patient. They are designed in theory to support the function of the TMJ and relieve associated pain. Stabilization splints are believed to function by stabilizing the intracapsular structure of the TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).
Device: Dental Care & Self Care
Following the dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions made. Interocclusal records will be made with a fast setting silicone using a metal tray. A commercial laboratory will then wax and heat process a clear acrylic resin splint attempting to capture the mandibular cusp tips in the occlusal plan of the splint. The splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. The splint will then be polished and home care instruction provided. Patients will be instructed to wear the splint at night and two hours per day.
Sham Comparator: Sham AMCT & Self Care
This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.
Other: Sham AMCT
This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient.
Placebo Comparator: Self-care only group
All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.
Other: Self-Care Only Group
Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)
Time Frame: 2 months
The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oral Health Impact Profile (OHIP-14)
Time Frame: 2 months
The OHIP-14 contains 2 questions about each of 7 dimensions (14 items), indicating how often the participant had experienced each difficulty in the previous month; possible responses range from 0 (never) to 4 (very often). The OHIP score was obtained by summing the 14 ratings.
2 months
Bothersomeness of Symptoms
Time Frame: 2 months
Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Palmer College of Chiropractic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Iowa
National Center for Complementary and Integrative Health (NCCIH)
Schaeffer Chiropractic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James W DeVocht, DC, PhD, Palmer College of Chiropractic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCRC1-P2
  • 5U19AT004663-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Once the resulting manuscripts have been published, data sets will be provided for public access. Potential investigators can contact one of the Co-PIs to present their hypothesis, study design, instruments and/or data on which to focus, and resources required. Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified or limited data sets that are transmitted to the requesting parties for additional analyses.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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