PainPhase 2NCT01770912
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
A Phase 2 study testing Lactated Ringers and Triamcinolone hexacetonide in people with Pain, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Lactated Ringers and Triamcinolone hexacetonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 24 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 18-80 years of age
- TMJ arthralgia
- Masticatory myalgia
- TMJ sounds
- History of at least 6 weeks use of occlusal appliance therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida College of Dentistry
Gainesville, Florida, 32610
About this study
Official title: A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Lactated Ringers, Triamcinolone hexacetonide
- Keywords
- facial pain, temporomandibular joint, arthrocentesis, steroid
- Medical subject headings
- Pain, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated RingersDrug
Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Triamcinolone hexacetonideDrug
Also called Aristospan, steroid
1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringers | Placebo comparator | 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure. Receives: Drug: Lactated Ringers |
| Triamcinolone acetonide | Active comparator | 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure. Receives: Drug: Triamcinolone hexacetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Measured: Baseline and 12 weeks post-treatment
Secondary outcomes (14)
Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Measured: Baseline and 2 weeks post-treatment
Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Measured: Baseline and 6 weeks post-treatment
Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks
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. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Measured: Baseline and 2 weeks post-treatment
Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks
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. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Measured: Baseline and 6 weeks post-treatment
Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks
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. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Measured: Baseline and 12 weeks post-treatment
Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks
Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Measured: Baseline and 2 weeks post-treatment
Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks
Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Measured: Baseline and 6 weeks post-treatment
Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks
Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Measured: Baseline and 12 weeks post-treatment
Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Measured: Baseline and 2 weeks post-treatment
Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Measured: Baseline and 6 weeks post-treatment
Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Measured: Baseline and 12 weeks post-treatment
Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks
Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".
Measured: Baseline and 2 weeks post-treatment
Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks
Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".
Measured: Baseline and 6 weeks post-treatment
Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks
Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".
Measured: Baseline and 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startMar 2013
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles G. Widmer, DDS, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770912
- Sponsor's protocol ID
- IRB201600060
- Status last verified
- Sep 2020
- First submitted
- 11 Jan 2013
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.
PubMed 1298767
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis
- ClinicalTrials.gov ID
- NCT01770912
- Acronym / sponsor ID
- IRB201600060
- Conditions
- Pain
- Keywords
- facial pain, temporomandibular joint, arthrocentesis, steroid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringers | Placebo comparator | Drug: Lactated Ringers1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure. |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone hexacetonide1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- 18-80 years of age
- TMJ arthralgia
- Masticatory myalgia
- TMJ sounds
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactated RingersSolution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure. | Drug | Lactated Ringers |
| Triamcinolone hexacetonideAlso: Aristospan, steroid1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure. | Drug | Triamcinolone acetonide |
Primary outcome
Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks
Time frame: Baseline and 12 weeks post-treatment
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
14 secondary outcomes
Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks
Time frame: Baseline and 2 weeks post-treatment
Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks
Time frame: Baseline and 6 weeks post-treatment
Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks
Time frame: Baseline and 2 weeks post-treatment
Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks
Time frame: Baseline and 6 weeks post-treatment
Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks
Time frame: Baseline and 12 weeks post-treatment
Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks
Time frame: Baseline and 2 weeks post-treatment
Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks
Time frame: Baseline and 6 weeks post-treatment
Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks
Time frame: Baseline and 12 weeks post-treatment
Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks
Time frame: Baseline and 2 weeks post-treatment
Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks
Time frame: Baseline and 6 weeks post-treatment
Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks
Time frame: Baseline and 12 weeks post-treatment
Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks
Time frame: Baseline and 2 weeks post-treatment
Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks
Time frame: Baseline and 6 weeks post-treatment
Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks
Time frame: Baseline and 12 weeks post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1298767Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles G. Widmer, DDS, MS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactated Ringers and Triamcinolone hexacetonide in people with Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks (time frame: Baseline and 12 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01770912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.