Conservative Treatment of Patients With Temporomandibular Disorders

Completed · Not applicable · Has a placebo group

Conditions studied: Temporomandibular Disorders

In brief

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.

Key facts

Study ID: NCT01021306
Run by: Palmer College of Chiropractic
People needed: 80
Starts: 2010-01-01
Expected to finish: 2012-05-01
Last updated by the study team: 2017-05-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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