An interventional study of Cervical Spine Thrust Joint Manipulation and Cervical Spine Sham Manipulation in Temporomandibular Disorder, sponsored by Bradley University. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by Bradley University · Not applicable, Interventional, and Treatment
Among 59 studies in Temporomandibular Joint Disorders with a site in United States — 17 open to participants now, 20 under way, none of them phase 3. Temporomandibular Joint Disorders · United States.
Among the 59 studies in Temporomandibular Joint Disorders with a site in United States, this one is the 28th largest by enrollment of the 46 interventional ones that give a count, is the only one that started in 2017, is one of 29 with no phase, and was the 25th registered.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
Browse Temporomandibular Joint Disorders studies →17 of the 59 studies in Temporomandibular Joint Disorders with a site in United States are open now. Recruiting first, the newest first:
Arpana Church · Sites in United States
University of Minnesota · Sites in United States
University of North Carolina, Chapel Hill · Sites in United States
University of Minnesota · Sites in United States
Theranica · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 75 Temporomandibular Joint Disorders studies recruiting now, 26 (35%) set no upper age limit and 45 (60%) stop at 75 or younger; 7 take children under 18; 23 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 12 · Phase 3 2 · Phase 4 1
First in 1997; this study’s year is marked. 1 started in 2017.
This study's enrollment of 50 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Median enrollment 60 across the 46 interventional studies, 180 across the 11 observational. Of the 36 that completed or were terminated, 16 (44%) have results posted.
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5 of 59 have an industry lead sponsor. The 10 most frequent:
Bradley University is the lead sponsor of 3 studies on the registry; none are open to participants now.
Bradley University has 1 study filed under Temporomandibular Joint Disorders — fewer than ten, so there is no comparison to draw.
10 of the studies in Temporomandibular Joint Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06977100University of FloridaJournaling Intervention for Temporomandibular Disorder (TMD) and Chronic Overlapping Pain | 2026-11 |
| NCT07226505Loyola UniversityEffects of Core Strengthening Exercises for Treating TMD | 2026-12-01 |
| NCT06617494University of MinnesotaEndogenous Pain Inhibition Deficiency in Chronic TMD Pain | 2026-12-31 |
| NCT07153107University of MinnesotaR01_Pilot Jaw Muscle Phenotypes | 2027-01-12 |
| NCT04376333UConn HealthIndividualized Assessment and Treatment for TMD | 2027-03-31 |
Among the 59 studies in Temporomandibular Joint Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Background: Temporomandibular disorder (TMD) is a common and costly problem that often leads to chronic pain or dysfunction. There is moderate evidence to support physical therapy (PT) interventions for individuals with TMD, yet they continue to be an underserved population. A known relationship between TMD and the cervical spine exists with some evidence to support the use of cervical interventions for TMD. Cervical spine thrust joint manipulation (TJM) is an effective PT intervention that has been explored in a limited fashion for this population.
The purpose of this trial is to determine the immediate and short term (1 and 4 week) effects of cervical TJM delivered by a physical therapist on pain, dysfunction, and perception of change in persons with a primary complaint of TMD. The hypothesis is that all participants will improve, and those in the cervical TJM group may have a greater degree of improvement.
Design: Participants will be randomized to one of two groups and all will receive physical therapy. Forty-two willing participants, age 18-65 with TMD will complete the informed consent process and screening for eligibility before being admitted. Participants will receive a combined treatment of 1) behavioral education, a home exercise program, soft tissue mobilization, and cervical spine TJM or 2) behavioral education, a home exercise program, soft tissue mobilization, and sham manipulation. Participants will receive 4 treatments over a period of 4 weeks.
Significance: The results of this clinical trial will provide evidence relative to the impact of cervical spine TJM in the treatment of persons with TMD. Determining the effectiveness of cervical spine TJM included with a combined treatment approach has clinical implication for physical therapists and the patients they serve.
Methods: Research design following CONSORT guidelines. A blinded assessor will measure ROM and PPT. Treating therapists will know group allocation and will receive training to standardize assessments and treatments. Self-report and objective measurements will be taken at baseline, immediately after treatment one, and at one and four week follow-ups.
Data Analysis (primary): Sample size estimations were completed using G-Power, a free online downloadable program. An F-test family with ANOVA: Repeated measures, within-between interaction protocol was selected. While it is optimal to power sample size estimations around a functional outcome measure, the limited use of functional measures in this population created an obstacle. The sample size estimation for this project was powered around maximal mouth opening (MMO) as this most closely relates to function in the TMD population. In order to account for 15% attrition, and maintain equal participants in each arm of this study, the desired sample size is 42 participants.
A 2 x 4 mixed model analysis of variance (ANOVA) will be used with treatment group as the between-subjects factor and time as the within-subjects factor. Separate ANOVAs will be performed for dependent variables and the hypothesis of interest will be group by time interaction for each ANOVA.
To determine if missing data points associated with dropouts were missing at random or missing for systematic reasons, we will perform Little's Missing Completely at Random (MCAR) Test. Intention to treat analysis will be performed by using expectation maximization whereby missing data are computed using regression equations. Planned pair-wise comparisons will examine the difference between baseline and follow-up periods using the Bonferroni equality at an alpha level of 0.05.
Success will be dichotomized using the GROC scale. A cut-off score of +5 or higher on the GROC will be used as a measure of success. Correlations between outcome measures (change scores) and success will be analyzed using an independent t-test to determine if differences between groups exist. Number needed to treat (NNT) will be calculated. Correlations among dependent variables will be analyzed with Pearson/Spearman correlations. Examples include the following: correlation between NDI and jaw functional measures, correlation among PPT at various areas tested, and correlation between change in ROM and change in functional scores. Data analysis will include 95% confidence intervals, and tables, charts, or other figures will be utilized to display findings to enhance reader understanding. Effect size of primary outcome measures including jaw ROM, JFLS, and TMD Disability Index will be calculated and reported. If there is no significant difference between groups noted, a post-hoc power analysis will be performed to determine the risk of Type II error.
Data Safety Plan/Subject Confidentiality: The PI will be responsible for educating all clinicians, research assistants, and front office staff with RVPT, Bradley University, and UNLV in confidentiality measures and data safety plans. This information will be part of the live training and included in the Manuals of Standard Operating Procedures. The PI will also periodically check in with each participating clinician, blinded assessor, and clinic office staff member to review procedures and monitor recruitment and retention. This check will occur once per month over the phone.
Standard Operating Procedures: Manual developed and used in training.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thrust Manipulation delivered to C0/1 and C2/3 on both the right and left side
Other: Cervical Spine Thrust Joint Manipulation · Other: Home Program · Other: Suboccipital Release
Sham Manipulation delivered to C0/1 and C2/3 on both the right and left side
Other: Cervical Spine Sham Manipulation · Other: Home Program · Other: Suboccipital Release
High velocity, short amplitude thrust to the cervical spine
Also known as: Grade V manipulation
Manipulative hold position shy of end range without a thrust
therapeutic exercise program and education
suboccipital soft tissue mobilization
Also known as: soft tissue mobilization
Change in Maximal Mouth Opening Range of Motion (mm)
Jaw ROM, mouth opening
Time frame: baseline, immediate, 1 week, 4 week
Change in Pain with Numeric Pain Rating Scale
NPRS, self-reported intensity of pain on 0-10 pain rating scale
Time frame: baseline, immediate, 1 week, 4 week
Change in Function with Jaw Functional Limitation Scale
JFLS, self report jaw functions rated 0-10 based on difficulty
Time frame: baseline, 1 week, 4 week, 3 month, 6 month
Change in Fear with Tampa Scale of Kinesiophobia-TMD version
self report scale to assess level of fear rating 12 items on a 1-4 scale
Time frame: baseline, 1 week, 4 week, 3 month, 6 month
Global Rating of Change
perception of overall change in a self report scale from -7 to +7
Time frame: immediate, 1 week, 4 week
Change in Function with Neck Disability Index
10 item self report assessment of neck disability
Time frame: baseline, 1 week, 4 week, 3 month, 6 month
Change in Function with TMD Disability Index
10 item self report assessment of jaw dysfunction
Time frame: baseline, 1 week, 4 week, 3 month, 6 month
Patient Acceptable Symptom State
Self report acceptable nature of current state
Time frame: 4 week, 3 month, 6 month
Change in Cervical Spine range of motion
bubble inclinometer measurement of neck motion
Time frame: baseline, immediate, 1 week, 4 week
Change in Pain pressure threshold
digital algometer assessment of threshold
Time frame: baseline, immediate, 1 week, 4 week
PHQ-2 Depression Screen
2 question screen
Time frame: baseline
Plan to share: No
Ran from Oct 2017 to primary completion in Oct 2018, 11 months.
Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 11 months is close to that.
Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders →