Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01770912
First received: January 11, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment.

All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A pregnancy test (urine test) will be conducted on all women of child-bearing age to verify that the patient is not pregnant before the rinsing procedure. The patient will fill out a short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.


Condition Intervention Phase
Pain
Drug: Lactated Ringers
Drug: Triamcinolone hexacetonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change from Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks [ Time Frame: Baseline and 12 weeks post-treatment ] [ Designated as safety issue: No ]
    TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).


Secondary Outcome Measures:
  • Change from Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
    TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).

  • Change from Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]
    TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).

  • Change From Pre-Treatment in Mandibular Range of Motion at 2 Weeks [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion.

  • Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]
    Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion.

  • Change From Pre-Treatment in Mandibular Range of Motion at 12 Weeks [ Time Frame: Baseline and 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion.

  • Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation). A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations.

  • Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]
    Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation). A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations.

  • Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks [ Time Frame: Baseline and 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation). A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations.

  • Change From Pre-Treatment Pain Location at 2 Weeks [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain location in jaw joint, muscles or both and right or left side of pain.

  • Change From Pre-Treatment Pain Location at 6 Weeks [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain location in jaw joint, muscles or both and right or left side of pain.

  • Change From Pre-Treatment Pain Location at 12 Weeks [ Time Frame: Baseline and 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain location in jaw joint, muscles or both and right or left side of pain.

  • Change From Pre-Treatment Joint Sounds in 2 Weeks [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.

  • Change From Pre-Treatment Joint Sounds in 6 Weeks [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]
    Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.

  • Change From Pre-Treatment Joint Sounds in 12 Weeks [ Time Frame: Baseline and 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.

  • Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain is assessed for average chewing pain intensity using a visual analog scale.

  • Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain is assessed for average chewing pain intensity using a visual analog scale.

  • Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks [ Time Frame: Baseline and 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain is assessed for average chewing pain intensity using a visual analog scale.

  • Change From Pre-Treatment Jaw Opening Pain at 2 weeks [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain is assessed during mandibular opening as present or absent.

  • Change From Pre-Treatment Jaw Opening Pain at 6 weeks [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain is assessed during mandibular opening as present or absent.

  • Change From Pre-Treatment Jaw Opening Pain at 12 weeks [ Time Frame: Baseline and 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Pain is assessed during mandibular opening as present or absent.

  • Change From Pre-Treatment Jaw Opening Pattern at 2 Weeks [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
    Jaw opening patterns are assessed as one of 5 different types.

  • Change From Pre-Treatment Jaw Opening Pattern at 6 Weeks [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]
    Jaw opening patterns are assessed as one of 5 different types.

  • Change From Pre-Treatment Jaw Opening Pattern at 12 Weeks [ Time Frame: Baseline and 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Jaw opening patterns are assessed as one of 5 different types.


Estimated Enrollment: 36
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lactated Ringers
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Drug: Lactated Ringers
Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Other Name: Lactated Ringers
Active Comparator: Triamcinolone hexacetonide
1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.
Drug: Triamcinolone hexacetonide
1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.
Other Names:
  • Aristospan
  • steroid

Detailed Description:

Temporomandibular joint disorders are common and poorly understood in terms of etiology and pathogenesis. These disorders are multifactorial in origin including physical and psychosocial aspects; however, there is little understanding as to how much each of these components are associated with a particular diagnosis and subsequent treatment outcome of temporomandibular joint disorders. There is also a paucity of information regarding the relative effectiveness of different therapies for the treatment of patients with temporomandibular joint disorders. The identification of the least invasive and most efficacious therapy is vital to proper management of these patients with temporomandibular joint pain.

Patients enrolled into the study will be examined and treated at the Department of Oral and Maxillofacial Surgery. At the first appointment, they will be examined following standard procedures to determine if they would potentially benefit from the TMJ arthrocentesis procedure. If the patient meets the inclusion criteria for the study and with their informed consent, they will be required to complete a questionnaire about their physical and pain symptoms and undergo a standardized clinical exam. At the next appointment, the patients will undergo the standard clinical protocol for TMJ arthrocentesis with either only normal saline or normal saline with adjunctive steroids (triamcinolone hexacetonide). Follow-up appointments will be at 2 weeks, 6 weeks and 12 weeks where the pain VAS and clinical exams will be completed.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 18-60 years of age
  • TMJ arthralgia
  • Masticatory myalgia
  • TMJ sounds
  • History of at least 6 weeks use of occlusal appliance therapy

Exclusion Criteria:

  • Contraindication to sedation including pregnancy or medical history
  • History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
  • History of steroidal injection into TMJ
  • History of trauma to TMJ
  • TMJ pain longer than 3 years
  • History of narcotic drug use on a scheduled basis
  • Current active infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770912

Contacts
Contact: Charles G. Widmer, DDS, MS 352-273-5696 widmer@dental.ufl.edu
Contact: Melvin (Frank) F. Dolwick, DMD, PhD 352-273-6750 fdolwick@dental.ufl.edu

Locations
United States, Florida
University of Florida College of Dentistry Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Charles G. Widmer, DDS, MS         
Principal Investigator: Melvin (Frank) F. Dolwick, DMS, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Charles G. Widmer, DDS, MS University of Florida
  More Information

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01770912     History of Changes
Other Study ID Numbers: 351-2012
Study First Received: January 11, 2013
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
facial pain
temporomandibular joint
arthrocentesis
steroid

Additional relevant MeSH terms:
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014