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

• 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: Palmer College of Chiropractic
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); University of Iowa; Schaeffer Chiropractic
• Information provided by (Responsible Party): Palmer College of Chiropractic

Study Description

Brief 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" 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.

Condition or disease	Intervention/treatment	Phase
Temporomandibular Disorders	Device: Chiropractic w/Activator & Self Care; Device: Dental Care & Self Care; Other: Sham AMCT; Other: Self-Care Only Group	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Conservative Treatment of Patients With Temporomandibular Disorders
• Study Start Date: January 2010
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: May 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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. Bothersomeness of Symptoms [ Time Frame: 2 months ]
   Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Iowa

Schaeffer Chiropractic

Coralville, Iowa, United States, 52241

Palmer College of Chirpractic

Davenport, Iowa, United States, 52803

University of Iowa College of Dentistry

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Palmer College of Chiropractic

National Center for Complementary and Integrative Health (NCCIH)

University of Iowa

Schaeffer Chiropractic

Investigators

• Principal Investigator: James W DeVocht, DC, PhD; Palmer College of Chiropractic

More Information

Publications of Results:

DeVocht 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.

Other 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.

Dodes JE. More about chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127.

Digregorio CJ. Questioning chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127.

Glick M, Pihlstrom BL. Response from the JADA Editor and the Associate Editor, Research. J Am Dent Assoc. 2014 Feb;145(2):127-8.

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

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

Additional relevant MeSH terms:

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes