ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 14 for:    Temporomandibular Joint Disorders | NIH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01021306
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : November 17, 2014
Last Update Posted : May 22, 2017
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
University of Iowa
Schaeffer Chiropractic
Information provided by (Responsible Party):
Palmer College of Chiropractic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Temporomandibular Disorders
Interventions: Device: Chiropractic w/Activator & Self Care
Device: Dental Care & Self Care
Other: Sham AMCT
Other: Self-Care Only Group

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Chiropractic w/Activator & Self Care

This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.

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.

Dental Care & Self Care

Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).

Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i

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.

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.

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.

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.


Participant Flow for 2 periods

Period 1:   2 Month (Primary Outcome)
    Chiropractic w/Activator & Self Care   Dental Care & Self Care   Sham AMCT & Self Care   Self-care Only Group
STARTED   20   20   19   21 
COMPLETED   14   14   14   17 
NOT COMPLETED   6   6   5   4 

Period 2:   6 Month (Follow-up)
    Chiropractic w/Activator & Self Care   Dental Care & Self Care   Sham AMCT & Self Care   Self-care Only Group
STARTED   14   14   14   17 
COMPLETED   11   13   14   14 
NOT COMPLETED   3   1   0   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chiropractic w/Activator & Self Care

This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.

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.

Dental Care & Self Care

Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).

Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i

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.

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.

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.

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.

Total Total of all reporting groups

Baseline Measures
   Chiropractic w/Activator & Self Care   Dental Care & Self Care   Sham AMCT & Self Care   Self-care Only Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   19   21   80 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.7  (7.9)   36.9  (13.5)   33.1  (11.4)   38.0  (12.7)   35.0  (11.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      16  80.0%      17  85.0%      15  78.9%      16  76.2%      64  80.0% 
Male      4  20.0%      3  15.0%      4  21.1%      5  23.8%      16  20.0% 
Region of Enrollment 
[Units: Participants]
         
United States   20   20   19   21   80 


  Outcome Measures

1.  Primary:   Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)   [ Time Frame: 2 months ]

Measure Type Primary
Measure Title Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)
Measure Description The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).
Time Frame 2 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chiropractic w/Activator & Self Care

This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.

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.

Dental Care & Self Care

Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).

Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i

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.

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.

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.

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.


Measured Values
   Chiropractic w/Activator & Self Care   Dental Care & Self Care   Sham AMCT & Self Care   Self-care Only Group 
Participants Analyzed   20   20   19   21 
Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS) 
[Units: Units on a scale]
Mean (95% Confidence Interval)
 0.9 
 (-0.1 to 1.8) 
 1.4 
 (0.3 to 2.5) 
 1.6 
 (0.6 to 2.6) 
 0.7 
 (-0.1 to 1.5) 

No statistical analysis provided for Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)



2.  Secondary:   Oral Health Impact Profile (OHIP-14)   [ Time Frame: 2 months ]

Measure Type Secondary
Measure Title Oral Health Impact Profile (OHIP-14)
Measure Description 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.
Time Frame 2 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chiropractic w/Activator & Self Care

This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.

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.

Dental Care & Self Care

Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).

Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i

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.

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.

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.

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.


Measured Values
   Chiropractic w/Activator & Self Care   Dental Care & Self Care   Sham AMCT & Self Care   Self-care Only Group 
Participants Analyzed   20   20   19   21 
Oral Health Impact Profile (OHIP-14) 
[Units: Units on a scale]
Mean (95% Confidence Interval)
 1.3 
 (-2.3 to 5.0) 
 3.6 
 (0.1 to 7.2) 
 2.0 
 (-1.8 to 5.8) 
 2.8 
 (-0.4 to 6.1) 

No statistical analysis provided for Oral Health Impact Profile (OHIP-14)



3.  Secondary:   Bothersomeness of Symptoms   [ Time Frame: 2 months ]

Measure Type Secondary
Measure Title Bothersomeness of Symptoms
Measure Description Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)
Time Frame 2 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chiropractic w/Activator & Self Care

This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.

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.

Dental Care & Self Care

Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).

Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i

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.

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.

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.

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.


Measured Values
   Chiropractic w/Activator & Self Care   Dental Care & Self Care   Sham AMCT & Self Care   Self-care Only Group 
Participants Analyzed   20   20   19   21 
Bothersomeness of Symptoms 
[Units: Units on a scale]
Mean (95% Confidence Interval)
 2.3 
 (0.5 to 4.1) 
 2.4 
 (0.6 to 4.2) 
 2.3 
 (0.7 to 4.0) 
 1.8 
 (0.3 to 3.3) 

No statistical analysis provided for Bothersomeness of Symptoms




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. James DeVocht
Organization: Palmer Center for Chiropractic Research, Palmer College of Chiropractic
phone: 563.884.5150
e-mail: james.devocht@palmer.edu


Publications of Results:
Other Publications:

Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT01021306     History of Changes
Other Study ID Numbers: DCRC1-P2
5U19AT004663-02 ( U.S. NIH Grant/Contract )
First Submitted: November 24, 2009
First Posted: November 26, 2009
Results First Submitted: October 31, 2014
Results First Posted: November 17, 2014
Last Update Posted: May 22, 2017