Temporomandibular DisorderNCT03300297
Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder
A study testing Cervical Spine Thrust Joint Manipulation, Home Program and Suboccipital Release in people with Temporomandibular Disorder, run by Bradley University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Cervical Spine Thrust Joint Manipulation, Home Program and Suboccipital Release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2017to 6 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 y/o
- primary complaint of TMD pain
- positive TMD screen
- proficiency in English language
- availability to attend 4 sessions
- minimum level of disability (NPRS 2 or greater)
- minimum level of disability (pain free mouth opening 50 mm or less).
Who cannot join
- traumatic onset of symptoms
- whiplash in the last 6 weeks
- prior neck surgery
- medical red flags suggestive on on-musculoskeletal origin of pain, systemic disease, or neurological disease
- contraindications to thrust joint manipulation (TJM),
- previous TJM in the last 3 months
- Worker's compensation
- pending litigation regarding pain or injury.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rock Valley Physical Therapy
Peoria, Illinois, 61614
Rock Valley Physical Therapy
Washington, Illinois, 61571
About this study
Official title: Thrust Joint Manipulation to the Cervical Spine in Participants With a Primary Complaint of Temporomandibular Disorder (TMD): A Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Temporomandibular Disorder
- Being tested
- Cervical Spine Thrust Joint Manipulation, Cervical Spine Sham Manipulation, Home Program, Suboccipital Release
- Keywords
- Temporomandibular joint, Physical Therapy, Cervical spine thrust joint manipulation, therapy, exercise, Temporomandibular Disorders
- Medical subject headings
- Temporomandibular Joint Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Spine Thrust Joint ManipulationOther
Also called Grade V manipulation
High velocity, short amplitude thrust to the cervical spine
Cervical Spine Sham ManipulationOther
Manipulative hold position shy of end range without a thrust
Home ProgramOther
therapeutic exercise program and education
Suboccipital ReleaseOther
Also called soft tissue mobilization
suboccipital soft tissue mobilization
| Study group | Role | What they receive |
|---|---|---|
| Cervical Spine Thrust Joint Manipulation | Active comparator | Thrust Manipulation delivered to C0/1 and C2/3 on both the right and left side Receives: Other: Cervical Spine Thrust Joint Manipulation; Other: Home Program; Other: Suboccipital Release |
| Cervical Spine Sham Manipulation | Sham comparator | Sham Manipulation delivered to C0/1 and C2/3 on both the right and left side Receives: Other: Cervical Spine Sham Manipulation; Other: Home Program; Other: Suboccipital Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Mouth Opening Range of Motion (mm)
Jaw ROM, mouth opening
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: immediate, 1 week, 4 week
Secondary outcomes (6)
Change in Function with Neck Disability Index
10 item self report assessment of neck disability
Measured: baseline, 1 week, 4 week, 3 month, 6 month
Change in Function with TMD Disability Index
10 item self report assessment of jaw dysfunction
Measured: baseline, 1 week, 4 week, 3 month, 6 month
Patient Acceptable Symptom State
Self report acceptable nature of current state
Measured: 4 week, 3 month, 6 month
Change in Cervical Spine range of motion
bubble inclinometer measurement of neck motion
Measured: baseline, immediate, 1 week, 4 week
Change in Pain pressure threshold
digital algometer assessment of threshold
Measured: baseline, immediate, 1 week, 4 week
PHQ-2 Depression Screen
2 question screen
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start18 Oct 2017
- Primary completion2 Oct 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two intervention groups. Both will receive intervention and one group will receive cervical spine thrust joint manipulation while the other receives sham manipulation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bradley University
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Southeastern University, University of Nevada, Las Vegas
- Responsible party
- Principal investigator, Breanna Reynolds, Bradley University
- Investigators
- Breanna C Reynolds, DPT, Principal investigator, Bradley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300297
- Sponsor's protocol ID
- BU 59-16
- Status last verified
- Feb 2019
- First submitted
- 28 Sep 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
PubMed 22036893Harrison AL, Thorp JN, Ritzline PD. A proposed diagnostic classification of patients with temporomandibular disorders: implications for physical therapists. J Orthop Sports Phys Ther. 2014 Mar;44(3):182-97. doi: 10.2519/jospt.2014.4847.
PubMed 24579796Kraus SL. Characteristics of 511 patients with temporomandibular disorders referred for physical therapy. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Oct;118(4):432-9. doi: 10.1016/j.oooo.2014.06.005. Epub 2014 Jul 2.
PubMed 25240990Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.
PubMed 26144684Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
PubMed 26294683McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25.
PubMed 16649894Paco M, Peleteiro B, Duarte J, Pinho T. The Effectiveness of Physiotherapy in the Management of Temporomandibular Disorders: A Systematic Review and Meta-analysis. J Oral Facial Pain Headache. 2016 Summer;30(3):210-20. doi: 10.11607/ofph.1661.
PubMed 27472523Silveira A, Gadotti IC, Armijo-Olivo S, Biasotto-Gonzalez DA, Magee D. Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders. Biomed Res Int. 2015;2015:512792. doi: 10.1155/2015/512792. Epub 2015 Mar 26.
PubMed 25883963Olivo SA, Fuentes J, Major PW, Warren S, Thie NM, Magee DJ. The association between neck disability and jaw disability. J Oral Rehabil. 2010 Sep;37(9):670-9. doi: 10.1111/j.1365-2842.2010.02098.x. Epub 2010 May 27.
PubMed 20524969La Touche R, Fernandez-de-las-Penas C, Fernandez-Carnero J, Escalante K, Angulo-Diaz-Parreno S, Paris-Alemany A, Cleland JA. The effects of manual therapy and exercise directed at the cervical spine on pain and pressure pain sensitivity in patients with myofascial temporomandibular disorders. J Oral Rehabil. 2009 Sep;36(9):644-52. doi: 10.1111/j.1365-2842.2009.01980.x. Epub 2009 Jul 14.
PubMed 19627454La Touche R, Paris-Alemany A, Mannheimer JS, Angulo-Diaz-Parreno S, Bishop MD, Lopez-Valverde-Centeno A, von Piekartz H, Fernandez-Carnero J. Does mobilization of the upper cervical spine affect pain sensitivity and autonomic nervous system function in patients with cervico-craniofacial pain?: A randomized-controlled trial. Clin J Pain. 2013 Mar;29(3):205-15. doi: 10.1097/AJP.0b013e318250f3cd.
PubMed 22874091Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, Ohrbach R. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011 Oct;142(10):1183-91. doi: 10.14219/jada.archive.2011.0088.
PubMed 21965492Kraus S. Temporomandibular disorders, head and orofacial pain: cervical spine considerations. Dent Clin North Am. 2007 Jan;51(1):161-93, vii. doi: 10.1016/j.cden.2006.10.001.
PubMed 17185065Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73.
PubMed 16813476Calixtre LB, Moreira RF, Franchini GH, Alburquerque-Sendin F, Oliveira AB. Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials. J Oral Rehabil. 2015 Nov;42(11):847-61. doi: 10.1111/joor.12321. Epub 2015 Jun 7.
PubMed 26059857
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrust Joint Manipulation to the Cervical Spine in Participants With a Primary Complaint of Temporomandibular Disorder (TMD): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03300297
- Acronym / sponsor ID
- BU 59-16
- Conditions
- Temporomandibular Disorder
- Keywords
- Temporomandibular joint, Physical Therapy, Cervical spine thrust joint manipulation, therapy, exercise, Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bradley UniversityUniversity, hospital or other
- Collaborators
- Nova Southeastern University, University of Nevada, Las Vegas
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two intervention groups. Both will receive intervention and one group will receive cervical spine thrust joint manipulation while the other receives sham manipulation.
| Arm | Type | Receives |
|---|---|---|
| Cervical Spine Thrust Joint Manipulation | Active comparator | Other: Cervical Spine Thrust Joint Manipulation, Other: Home Program, Other: Suboccipital ReleaseThrust Manipulation delivered to C0/1 and C2/3 on both the right and left side |
| Cervical Spine Sham Manipulation | Sham comparator | Other: Cervical Spine Sham Manipulation, Other: Home Program, Other: Suboccipital ReleaseSham Manipulation delivered to C0/1 and C2/3 on both the right and left side |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-65 y/o
- primary complaint of TMD pain
- positive TMD screen
- proficiency in English language
- availability to attend 4 sessions
Key exclusion criteria (8 listed)
- traumatic onset of symptoms
- whiplash in the last 6 weeks
- prior neck surgery
- medical red flags suggestive on on-musculoskeletal origin of pain, systemic disease, or neurological disease
- contraindications to thrust joint manipulation (TJM),
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 |
|---|---|---|
| Cervical Spine Thrust Joint ManipulationAlso: Grade V manipulationHigh velocity, short amplitude thrust to the cervical spine | Other | Cervical Spine Thrust Joint Manipulation |
| Cervical Spine Sham ManipulationManipulative hold position shy of end range without a thrust | Other | Cervical Spine Sham Manipulation |
| Home Programtherapeutic exercise program and education | Other | Cervical Spine Sham Manipulation, Cervical Spine Thrust Joint Manipulation |
| Suboccipital ReleaseAlso: soft tissue mobilizationsuboccipital soft tissue mobilization | Other | Cervical Spine Sham Manipulation, Cervical Spine Thrust Joint Manipulation |
Primary outcome
Change in Maximal Mouth Opening Range of Motion (mm)
Time frame: baseline, immediate, 1 week, 4 week
Jaw ROM, mouth opening
Change in Pain with Numeric Pain Rating Scale
Time frame: baseline, immediate, 1 week, 4 week
NPRS, self-reported intensity of pain on 0-10 pain rating scale
Change in Function with Jaw Functional Limitation Scale
Time frame: baseline, 1 week, 4 week, 3 month, 6 month
JFLS, self report jaw functions rated 0-10 based on difficulty
Change in Fear with Tampa Scale of Kinesiophobia-TMD version
Time frame: baseline, 1 week, 4 week, 3 month, 6 month
self report scale to assess level of fear rating 12 items on a 1-4 scale
Global Rating of Change
Time frame: immediate, 1 week, 4 week
perception of overall change in a self report scale from -7 to +7
6 secondary outcomes
Change in Function with Neck Disability Index
Time frame: baseline, 1 week, 4 week, 3 month, 6 month
Change in Function with TMD Disability Index
Time frame: baseline, 1 week, 4 week, 3 month, 6 month
Patient Acceptable Symptom State
Time frame: 4 week, 3 month, 6 month
Change in Cervical Spine range of motion
Time frame: baseline, immediate, 1 week, 4 week
Change in Pain pressure threshold
Time frame: baseline, immediate, 1 week, 4 week
PHQ-2 Depression Screen
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Background: PubMed 22036893Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
- Background: PubMed 24579796Harrison AL, Thorp JN, Ritzline PD. A proposed diagnostic classification of patients with temporomandibular disorders: implications for physical therapists. J Orthop Sports Phys Ther. 2014 Mar;44(3):182-97. doi: 10.2519/jospt.2014.4847.
- Background: PubMed 25240990Kraus SL. Characteristics of 511 patients with temporomandibular disorders referred for physical therapy. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Oct;118(4):432-9. doi: 10.1016/j.oooo.2014.06.005. Epub 2014 Jul 2.
- Background: PubMed 26144684Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, Lagoa Goncalves KF, Bonini-Rocha AC, Dugailly PM, de Oliveira RJ. Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: A systematic review with meta-analysis. Man Ther. 2016 Feb;21:10-7. doi: 10.1016/j.math.2015.06.009. Epub 2015 Jun 25.
- Background: PubMed 26294683Armijo-Olivo S, Pitance L, Singh V, Neto F, Thie N, Michelotti A. Effectiveness of Manual Therapy and Therapeutic Exercise for Temporomandibular Disorders: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jan;96(1):9-25. doi: 10.2522/ptj.20140548. Epub 2015 Aug 20.
- Background: PubMed 16649894McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25.
- Background: PubMed 27472523Paco M, Peleteiro B, Duarte J, Pinho T. The Effectiveness of Physiotherapy in the Management of Temporomandibular Disorders: A Systematic Review and Meta-analysis. J Oral Facial Pain Headache. 2016 Summer;30(3):210-20. doi: 10.11607/ofph.1661.
- Background: PubMed 25883963Silveira A, Gadotti IC, Armijo-Olivo S, Biasotto-Gonzalez DA, Magee D. Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders. Biomed Res Int. 2015;2015:512792. doi: 10.1155/2015/512792. Epub 2015 Mar 26.
- Background: PubMed 20524969Olivo SA, Fuentes J, Major PW, Warren S, Thie NM, Magee DJ. The association between neck disability and jaw disability. J Oral Rehabil. 2010 Sep;37(9):670-9. doi: 10.1111/j.1365-2842.2010.02098.x. Epub 2010 May 27.
- Background: PubMed 19627454La Touche R, Fernandez-de-las-Penas C, Fernandez-Carnero J, Escalante K, Angulo-Diaz-Parreno S, Paris-Alemany A, Cleland JA. The effects of manual therapy and exercise directed at the cervical spine on pain and pressure pain sensitivity in patients with myofascial temporomandibular disorders. J Oral Rehabil. 2009 Sep;36(9):644-52. doi: 10.1111/j.1365-2842.2009.01980.x. Epub 2009 Jul 14.
- Background: PubMed 22874091La Touche R, Paris-Alemany A, Mannheimer JS, Angulo-Diaz-Parreno S, Bishop MD, Lopez-Valverde-Centeno A, von Piekartz H, Fernandez-Carnero J. Does mobilization of the upper cervical spine affect pain sensitivity and autonomic nervous system function in patients with cervico-craniofacial pain?: A randomized-controlled trial. Clin J Pain. 2013 Mar;29(3):205-15. doi: 10.1097/AJP.0b013e318250f3cd.
- Background: PubMed 21965492Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, Ohrbach R. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011 Oct;142(10):1183-91. doi: 10.14219/jada.archive.2011.0088.
- Individual participant dataSharing planned: No
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Temporomandibular Joint Disorders
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.
Breanna C Reynolds, DPT principal investigator
Bradley University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Spine Thrust Joint Manipulation, Home Program and Suboccipital Release in people with Temporomandibular Disorder, run by Bradley University at 2 sites 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 7 inclusion and 8 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Maximal Mouth Opening Range of Motion (mm) (time frame: baseline, immediate, 1 week, 4 week). The study lists 5 primary outcomes in all. 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 NCT03300297, which also lists 23 linked publications.
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 18 Feb 2019.