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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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.
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.
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 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.
Schaeffer Chiropractic
Coralville, Iowa, United States
Palmer College of Chirpractic
Davenport, Iowa, United States
University of Iowa College of Dentistry
Iowa City, Iowa, United States
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).
Time frame: 2 months
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.
Time frame: 2 months
Bothersomeness of Symptoms
Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)
Time frame: 2 months
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