Temporomandibular DisordersD1P2-TMDNCT01021306
Conservative Treatment of Patients With Temporomandibular Disorders
A study testing Chiropractic w/Activator & Self Care, Dental Care & Self Care and Self-Care Only Group in people with Temporomandibular Disorders, run by Palmer College of Chiropractic at 3 sites in United States.
Trial summary
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"… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Chiropractic w/Activator & Self Care, Dental Care & Self Care and Self-Care Only Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Schaeffer Chiropractic
Coralville, Iowa, 52241
Palmer College of Chirpractic
Davenport, Iowa, 52803
University of Iowa College of Dentistry
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Conditions
- Temporomandibular Disorders
- Being tested
- Chiropractic w/Activator & Self Care, Dental Care & Self Care, Sham AMCT, Self-Care Only Group
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic w/Activator & Self CareDevice
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 CareDevice
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 AMCTOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic w/Activator & Self Care | Active comparator | This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. Receives: Device: Chiropractic w/Activator & Self Care |
| Dental Care & Self Care | Active comparator | 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). Receives: Device: Dental Care & Self Care |
| Sham AMCT & Self Care | Sham comparator | 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. Receives: Other: Sham AMCT |
| Self-care only group | Placebo comparator | 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. Receives: Other: Self-Care Only Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)
The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).
Measured: 2 months
Secondary outcomes (2)
Oral Health Impact Profile (OHIP-14)
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.
Measured: 2 months
Bothersomeness of Symptoms
Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palmer College of Chiropractic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Iowa, Schaeffer Chiropractic
- Responsible party
- Sponsor
- Investigators
- James W DeVocht, DC, PhD, Principal investigator, Palmer College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021306
- Sponsor's protocol ID
- DCRC1-P2
- Other IDs
- 5U19AT004663-02
- Acronym
- D1P2-TMD
- Status last verified
- Apr 2017
- First submitted
- 24 Nov 2009
- Last updated
- 22 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
Salsbury SA, DeVocht JW, Hondras MA, Seidman MB, Stanford CM, Goertz CM. Chiropractor interaction and treatment equivalence in a pilot randomized controlled trial: an observational analysis of clinical encounter video-recordings. Chiropr Man Therap. 2014 Dec 3;22(1):42. doi: 10.1186/s12998-014-0042-7. eCollection 2014.
PubMed 25478142Dodes JE. More about chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127. doi: 10.1016/s0002-8177(14)60212-9. No abstract available.
PubMed 24487602Digregorio CJ. Questioning chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127. doi: 10.1016/s0002-8177(14)60211-7. No abstract available.
PubMed 24487601Glick M, Pihlstrom BL. Response from the JADA Editor and the Associate Editor, Research. J Am Dent Assoc. 2014 Feb;145(2):127-8. doi: 10.1016/s0002-8177(14)60213-0. No abstract available.
PubMed 24487603DeVocht JW, Goertz CM, Hondras MA, Long CR, Schaeffer W, Thomann L, Spector M, Stanford CM. A pilot study of a chiropractic intervention for management of chronic myofascial temporomandibular disorder. J Am Dent Assoc. 2013;144(10):1154-63. doi: 10.14219/jada.archive.2013.0034.
PubMed 24080932
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Patients With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT01021306
- Acronym / sponsor ID
- D1P2-TMD / DCRC1-P2
- Conditions
- Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Palmer College of ChiropracticUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Iowa, Schaeffer Chiropractic
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Posted 17 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chiropractic w/Activator & Self Care | Active comparator | Device: Chiropractic w/Activator & Self CareThis technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. |
| Dental Care & Self Care | Active comparator | Device: Dental Care & Self CareIntraoral 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). |
| Sham AMCT & Self Care | Sham comparator | Other: Sham AMCTThis 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. |
| Self-care only group | Placebo comparator | Other: Self-Care Only GroupAll 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic w/Activator & Self CareThis 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. | Device | Chiropractic w/Activator & Self Care |
| Dental Care & Self CareFollowing 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. | Device | Dental Care & Self Care |
| Sham AMCTThis 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. | Other | Sham AMCT & Self Care |
| Self-Care Only GroupSelf 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. | Other | Self-care only group |
Primary outcome
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 secondary outcomes
Oral Health Impact Profile (OHIP-14)
Time frame: 2 months
Bothersomeness of Symptoms
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25478142Salsbury SA, DeVocht JW, Hondras MA, Seidman MB, Stanford CM, Goertz CM. Chiropractor interaction and treatment equivalence in a pilot randomized controlled trial: an observational analysis of clinical encounter video-recordings. Chiropr Man Therap. 2014 Dec 3;22(1):42. doi: 10.1186/s12998-014-0042-7. eCollection 2014.
- Background: PubMed 24487602Dodes JE. More about chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127. doi: 10.1016/s0002-8177(14)60212-9. No abstract available.
- Background: PubMed 24487601Digregorio CJ. Questioning chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127. doi: 10.1016/s0002-8177(14)60211-7. No abstract available.
- Background: PubMed 24487603Glick M, Pihlstrom BL. Response from the JADA Editor and the Associate Editor, Research. J Am Dent Assoc. 2014 Feb;145(2):127-8. doi: 10.1016/s0002-8177(14)60213-0. No abstract available.
- Results publication: PubMed 24080932DeVocht JW, Goertz CM, Hondras MA, Long CR, Schaeffer W, Thomann L, Spector M, Stanford CM. A pilot study of a chiropractic intervention for management of chronic myofascial temporomandibular disorder. J Am Dent Assoc. 2013;144(10):1154-63. doi: 10.14219/jada.archive.2013.0034.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James W DeVocht, DC, PhD principal investigator
Palmer College of Chiropractic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic w/Activator & Self Care, Dental Care & Self Care and Self-Care Only Group in people with Temporomandibular Disorders, run by Palmer College of Chiropractic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01021306, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.