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

This study has been completed.
Sponsor:
Collaborators:
University of Iowa
Schaeffer Chiropractic
Information provided by (Responsible Party):
Palmer College of Chiropractic
ClinicalTrials.gov Identifier:
NCT01021306
First received: November 24, 2009
Last updated: November 14, 2014
Last verified: November 2014
Results First Received: October 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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
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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
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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  
Number of Participants  
[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  
Gender  
[units: participants]
         
Female     16     17     15     16     64  
Male     4     3     4     5     16  
Region of Enrollment  
[units: participants]
         
United States     20     20     19     21     80  



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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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:

Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT01021306     History of Changes
Other Study ID Numbers: DCRC1-P2, 5U19AT004663-02
Study First Received: November 24, 2009
Results First Received: October 31, 2014
Last Updated: November 14, 2014
Health Authority: United States: Institutional Review Board