Clinical trial NCT01021306: Conservative Treatment of Patients With Temporomandibular Disorders
Official title: Conservative Treatment of Patients With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of Iowa
name: Schaeffer Chiropractic
First posted: 2009-11-26
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)
timeFrame: 2 months
Secondary outcomes:
measure: Oral Health Impact Profile (OHIP-14)
timeFrame: 2 months
measure: Bothersomeness of Symptoms
timeFrame: 2 months
Other outcomes:
Locations:
city: Coralville
country: United States
facility: Schaeffer Chiropractic
state: Iowa
city: Davenport
country: United States
facility: Palmer College of Chirpractic
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa College of Dentistry
state: Iowa
Study officials:
affiliation: Palmer College of Chiropractic
name: James W DeVocht, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Dodes JE. More about chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127. doi: 10.1016/s0002-8177(14)60212-9. No abstract available.
citation: Digregorio CJ. Questioning chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127. doi: 10.1016/s0002-8177(14)60211-7. No abstract available.
citation: Glick 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.
citation: 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. doi: 10.14219/jada.archive.2013.0034.