Trial Outcomes & Findings for Conservative Treatment of Patients With Temporomandibular Disorders (NCT NCT01021306)
NCT ID: NCT01021306
Last Updated: 2017-05-22
Results Overview
The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
2 months
Results posted on
2017-05-22
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
2 Month (Primary Outcome)
STARTED
|
20
|
20
|
19
|
21
|
|
2 Month (Primary Outcome)
COMPLETED
|
14
|
14
|
14
|
17
|
|
2 Month (Primary Outcome)
NOT COMPLETED
|
6
|
6
|
5
|
4
|
|
6 Month (Follow-up)
STARTED
|
14
|
14
|
14
|
17
|
|
6 Month (Follow-up)
COMPLETED
|
11
|
13
|
14
|
14
|
|
6 Month (Follow-up)
NOT COMPLETED
|
3
|
1
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Conservative Treatment of Patients With Temporomandibular Disorders
Baseline characteristics by cohort
| Measure |
Chiropractic w/Activator & Self Care
n=20 Participants
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
n=20 Participants
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
n=19 Participants
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
n=21 Participants
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
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
35.0 years
STANDARD_DEVIATION 11.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
21 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 monthsThe Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).
Outcome measures
| Measure |
Chiropractic w/Activator & Self Care
n=20 Participants
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
n=20 Participants
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
n=19 Participants
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
n=21 Participants
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.
|
|---|---|---|---|---|
|
Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)
|
0.9 units on a scale
Interval -0.1 to 1.8
|
1.4 units on a scale
Interval 0.3 to 2.5
|
1.6 units on a scale
Interval 0.6 to 2.6
|
0.7 units on a scale
Interval -0.1 to 1.5
|
SECONDARY outcome
Timeframe: 2 monthsThe 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.
Outcome measures
| Measure |
Chiropractic w/Activator & Self Care
n=20 Participants
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
n=20 Participants
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
n=19 Participants
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
n=21 Participants
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.
|
|---|---|---|---|---|
|
Oral Health Impact Profile (OHIP-14)
|
1.3 units on a scale
Interval -2.3 to 5.0
|
3.6 units on a scale
Interval 0.1 to 7.2
|
2.0 units on a scale
Interval -1.8 to 5.8
|
2.8 units on a scale
Interval -0.4 to 6.1
|
SECONDARY outcome
Timeframe: 2 monthsPossible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)
Outcome measures
| Measure |
Chiropractic w/Activator & Self Care
n=20 Participants
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
n=20 Participants
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
n=19 Participants
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
n=21 Participants
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.
|
|---|---|---|---|---|
|
Bothersomeness of Symptoms
|
2.3 units on a scale
Interval 0.5 to 4.1
|
2.4 units on a scale
Interval 0.6 to 4.2
|
2.3 units on a scale
Interval 0.7 to 4.0
|
1.8 units on a scale
Interval 0.3 to 3.3
|
Adverse Events
Chiropractic w/Activator & Self Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dental Care & Self Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham AMCT & Self Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-care Only Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. James DeVocht
Palmer Center for Chiropractic Research, Palmer College of Chiropractic
Phone: 563.884.5150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place