N/A
N=80
Conservative Treatment of Patients With Temporomandibular Disorders
Temporomandibular Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01021306 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS) — 0.9; 1.4; 1.6; 0.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chiropractic w/Activator & Self Care (Device); Dental Care & Self Care (Device); Sham AMCT (Other); Self-Care Only Group (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Palmer College of Chiropractic
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS) |
0.9; 1.4; 1.6; 0.7 | — |
| SECONDARY Oral Health Impact Profile (OHIP-14) |
1.3; 3.6; 2.0; 2.8 | — |
| SECONDARY Bothersomeness of Symptoms |
2.3; 2.4; 2.3; 1.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01021306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.