Conservative Treatment of Patients With Temporomandibular Disorders

NCT01021306 | Completed Results DMC

• 2 other identifiers: DCRC1-P25U19AT004663-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Temporomandibular Disorders

Outcome Measures

Primary Outcomes (1)

• 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).

  2 months

Secondary Outcomes (2)

• Oral Health Impact Profile (OHIP-14)

  2 months

• Bothersomeness of Symptoms

  2 months

Study Arms (4)

Chiropractic w/Activator & Self Care

ACTIVE COMPARATOR

This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.

Device: Chiropractic w/Activator & Self Care

Dental Care & Self Care

ACTIVE COMPARATOR

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

Sham AMCT & Self Care

SHAM COMPARATOR

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

Self-care only group

PLACEBO COMPARATOR

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

Interventions

Chiropractic w/Activator & Self Care DEVICE

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.

Chiropractic w/Activator & Self Care

Dental Care & Self Care DEVICE

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.

Dental Care & Self Care

Sham AMCT OTHER

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.

Sham AMCT & Self Care

Self-Care Only Group OTHER

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.

Self-care only group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Iowa: collaborator
• Schaeffer Chiropractic: collaborator

Study Sites (3)

Schaeffer Chiropractic

Coralville, Iowa, 52241, United States

Location

Palmer College of Chirpractic

Davenport, Iowa, 52803, United States

Location

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

• 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.

  PMID: 25478142 BACKGROUND

• 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.

  PMID: 24487602 BACKGROUND

• Digregorio CJ. Questioning chiropractics. J Am Dent Assoc. 2014 Feb;145(2):127. doi: 10.1016/s0002-8177(14)60211-7. No abstract available.

  PMID: 24487601 BACKGROUND

• 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.

  PMID: 24487603 BACKGROUND

• 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.

  PMID: 24080932 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Self Care; Dental Care

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Dentistry; Dental Health Services

Results Point of Contact

• Title: Dr. James DeVocht
• Organization: Palmer Center for Chiropractic Research, Palmer College of Chiropractic

james.devocht@palmer.edu

563.884.5150

Study Officials

• James W DeVocht, DC, PhD

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 26, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 22, 2017
• Results First Posted: November 17, 2014

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)