Whiplash Injury of Cervical SpineNCT06143228
Influence of Directional Preference on Movement Coordination Deficits in Individuals With Whiplash Associated Disorders
An observational study of Whiplash Injury of Cervical Spine and Muscle Weakness, run by D'Youville College at 2 sites in United States.
Trial summary
The aim of this prospective observational study is to investigate whether the presence or absence of directional preference impacts movement coordination impairments as measured in patients with Whiplash Associated Disorders (WAD). The primary research question this study aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Whiplash Injury of Cervical Spine, Muscle Weakness
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Dec 2023to 30 Dec 2024
- Phase
- Observational
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of interest for this study will consist of subjects meeting inclusion criteria referred by their physician to one of two out-patient physical therapy clinics located in the southwestern United States.
Who may be able to join
- Age 19-70
- Symptom complaints are related to a motor vehicle collision or trauma.
- Pain presents as unilateral or bilateral head/neck, upper back, or arm pain and/or stiffness
- Patient has been previously screened by their MD and received appropriate imaging to rule out the possibility of cervical fracture.
Who cannot join
- Neck pain is determined to be of non-cervical origin
- Malignancy/infection
- Presence of progressive neurological deficits
- Cranial or cervical vascular disorder
- Substance use or withdrawal
- Acute post cervical surgery
- Psychosis/psychiatric disorder/post-traumatic stress disorder
- Vertigo with nystagmus is present
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Center for Orthopedic & Sports Physical Therapy
Tallahassee, Florida, 32308
Katey Larson, DPT, 847-975-6468, kahterine.larson@impact.com
Katey Larson, DPT
- Recruiting
OrthoPT Spine & Joint Specialists Clinic
Tampa, Florida, 33613
Jonathan Dolutan, DPT, 843-343-7000, OrthoPTSpineJoint@icloud.com
Jonathan Dolutan, DPT
About this study
Official title: The Influence of Directional Preference on Movement Coordination Deficits in Individuals With Whiplash Associated Disorders
The aim of this prospective observational study is to investigate whether the presence or absence of directional preference impacts movement coordination impairments as measured in patients with Whiplash Associated Disorders (WAD).
The primary research question this study aims to answer is:
Read more
- Is the presence of directional preference in patients with WADs associated with more favorable improvements in the specific outcome measures as compared to those patients with WADs without the presence of directional preference.
Patients in this study will asked to complete the following measures at baseline, during care, discharge, and 3 month follow up.
- Numeric Pain Rating Scale (NPRS)
- Optimal Screening for Prediction and Referral and Outcome-Yellow Flag (OSPRO-YF)
- Neck Disability Index (NDI)
- Craniocervical Flexion Test (CCFT)
- Neck Flexor Endurance Test
- Cervical Range of Motion
Patients demonstrating a directional preference will be managed utilizing a Mechanical Diagnosis and Treatment approach (MDT) while those without directional preference will be managed according to published clinical practice guidelines for patients with Neck Pain and Movement Coordination Deficits (WADs).
Read the detailed description
Objective The primary aim of this prospective observational study is to investigate whether the presence or absence of directional preference impacts movement coordination impairments as measured at the start of care, during care, discharge, and at 3 month follow up. It is hypothesized that the presence of directional preference in patients with WADs may be associated with more favorable improvements in the specific outcome measures as compared to the group without the presence of directional preference.
Design: Prospective Observation Cohort Design
Background: Neck pain ranks 19th in global disability-adjusted life years with an overall prevalence of 27 per 1000 population with variation based on geographic location amongst other factors. The clinical course of neck pain is variable and not always favorable. A research dearth remains in whiplash associated disorders (WAD) and movement coordination issues for the cervical spine.
Movement coordination impairments are commonly associated with whiplash associated disorders. Poorer prognosis is associated with older age, higher initial neck disability index, high initial pain intensity. Recovery slows down after the first 6-12 weeks, and some patients have with persistent pain and disability even 1 year after the whiplash associated disorder. However, the prognostic value of limited cervical mobility and altered motor control has also been questioned. The use of mechanical diagnosis and therapy (MDT) has been associated with better function, range of motion, and overall lower costs in whiplash associated disorders at both the 6 and 36 month mark but whether the results differ from natural history or other approaches is debatable.
Setting:
The settings for subject recruitment and all data collection are two outpatient physical therapy clinics located in the southeastern United States during the period of September 2023 to September 2024. Prior approval for data collection will be obtained in writing from the clinic directors of both sites.
Sample and Population:
Convenience sampling will be utilized for this study. A G-power a priori power analysis with a medium effect size determined that a sample size of 55 is required to achieve a statistical power of .80 with an alpha level of .05. A total of 65 subjects will be recruited between the two data collection sites to account for an expected 20% attrition rate on follow up.
Procedures: Subjects referred to one of two out-patient physical therapy clinics meeting inclusion criteria will be evaluated, classified using a Mechanical Diagnosis and Treatment (MDT) approach. Those patients demonstrating a directional preference will be managed using an MDT approach while those not demonstration a directional preference will be managed using published clinical practice guidelines for patients with Movement Coordination Deficits (WADs). Outcome measures will be taken at baseline, visit 5, visit 10 or discharge (whichever comes first) and 3 month follow up.
Data Analyses:
Descriptive statistics will be used to assess patient baseline and change scores on the dependent variables of interest. Inferential statistics (linear regression) will be utilized to assess for statistically significant changes over time and between groups for the variables of interest.
- Conditions
- Whiplash Injury of Cervical Spine, Muscle Weakness
- Keywords
- Whiplash Associated Disorders, Movement Coordination Deficits, McKenzie, Neck Pain
- Medical subject headings
- Muscle Weakness, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Whiplash Associated Disorder with Directional Preference | Movements that reduce, abolish, or centralize the patient symptoms are recognized as a directional preference. Directional preference is ultimately used to guide the treatment of neck pain related to derangement syndrome.If the patient neck impairments are related to a Derangement syndrome, the patient will be instructed to perform the movements in the identified directional preference every 2-3 hours for 10-12 repetitions or to hold the cervical spine in a sustained position for 1-2 minutes. If the response to the intervention plateaus, the exercise intensity is progressed through the application of patient self-overpressure. If warranted clinician overpressure and mobilization may be utilized as a progression beyond patient generated forces. to achieve a favorable response. | |
| Whiplash Associated Disorder without Direction Preference | Patients with WADs that do not demonstrate directional preference will be managed based on the published Clinical Practice Guidelines (2017) for management of WADs with related movement coordination deficits. Treatment and progression of care for this group will be determined by the treating therapist but will consist of education, multimodal care inclusive of therapeutic exercise, mobilization, aerobic exercise, flexibility, and postural education. In addition, if the patient symptoms are chronic in nature treatment may include exercise progression, education and reassurance, transcutaneous nerve electrical stimulation, and cognitive behavioral therapy are recommended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniocervical Flexion Test (CCFT)
Measures the holding capacity of the deep cervical flexor muscles: longus capitis and longus coli.To measure the deficit, an inflatable pressure biofeedback device (Stabilizer, Chattanooga, Tennessee, USA) is placed behind the patient's neck while the patient is hook-lying in the supine position. The pressure sensor is inflated to a baseline pressure of 20 mmHg. The patient is then instructed to perform head nodding motions of craniocervical flexion. The patient is instructed to hold a head-nodding motion for ten seconds at a baseline of 20 mmHg. After this step, the patient's pressure is progressively increased by 2 mmHg in 10 second intervals until a maximum of 30 mmHg is achieved. If the patient failed to maintain the head-nodding position at a certain pressure, then the measurement is recorded.
Measured: Baseline, 3 weeks, 6 weeks
Neck Flexor Endurance Test:
Used to measure the holding capacity of the deep cervical flexor muscles. The participant was instructed to tuck their chin, lift their head off the table, and hold that position until exhaustion, or onset of symptoms. The physical therapist administering the test used a stopwatch to assess duration of hold. The test was concluded if the patient demonstrated any of the following: protrusion, shaking, onset or worsening of symptoms, or touching the table with their head.18, neck pain versus no neck pain.
Measured: Baseline, 3 weeks, 6 weeks
Cervical Range of Motion (CROM)
A standard goniometer will be used to measure patient range of motion for flexion, extension, side bending, and rotation. All measures will be completed in sitting and repeated two times in each direction. The standard error of measure for goniometry is 2.4 to 4.9 degrees
Measured: Baseline, 3 weeks, 6 weeks
Secondary outcomes (3)
The Numerical Pain Rating System (NPRS)
Used to measure the patients' pain and headache intensity. The NPRS is an 11-point scale where 0 designates 'No pain' and 10 designates 'The worst pain imaginable'.
Measured: Baseline, 3 weeks, 6 weeks, 3 months
Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF)
The OSPRO-YF informs treatment decision-making and facilitates treatment monitoring for patients determined to be at high risk for poor outcomes by existing risk-assessment tools. The 10-item version has been found to have an accuracy of 81% in identifying yellow flags
Measured: Baseline, 3 weeks, 6 weeks, 3 months
The Neck Disability Index (NDI)
A self-reported disability measure used in the study. A 5.5-point reduction in NDI score would deem the treatment clinically meaningful.
Measured: Baseline, 3 weeks, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start30 Dec 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Whiplash Injury of Cervical SpineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Youville College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Borgehammar, DSc, Study director, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143228
- Sponsor's protocol ID
- 081469
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If data is shared it would be deidentified data reported in aggregate format only.
Publications
Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
PubMed 28666405Ritchie C, Sterling M. Recovery Pathways and Prognosis After Whiplash Injury. J Orthop Sports Phys Ther. 2016 Oct;46(10):851-861. doi: 10.2519/jospt.2016.6918. Epub 2016 Sep 3.
PubMed 27594661Ritchie C, Hendrikz J, Jull G, Elliott J, Sterling M. External validation of a clinical prediction rule to predict full recovery and ongoing moderate/severe disability following acute whiplash injury. J Orthop Sports Phys Ther. 2015 Apr;45(4):242-50. doi: 10.2519/jospt.2015.5642.
PubMed 25827122Garcia AN, Costa LDCM, de Souza FS, de Almeida MO, Araujo AC, Hancock M, Costa LOP. Reliability of the Mechanical Diagnosis and Therapy System in Patients With Spinal Pain: A Systematic Review. J Orthop Sports Phys Ther. 2018 Dec;48(12):923-933. doi: 10.2519/jospt.2018.7876. Epub 2018 Jun 22.
PubMed 29932871Jull GA, O'Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. J Manipulative Physiol Ther. 2008 Sep;31(7):525-33. doi: 10.1016/j.jmpt.2008.08.003.
PubMed 18804003Domenech MA, Sizer PS, Dedrick GS, McGalliard MK, Brismee JM. The deep neck flexor endurance test: normative data scores in healthy adults. PM R. 2011 Feb;3(2):105-10. doi: 10.1016/j.pmrj.2010.10.023.
PubMed 21333948
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Directional Preference on Movement Coordination Deficits in Individuals With Whiplash Associated Disorders
- ClinicalTrials.gov ID
- NCT06143228
- Acronym / sponsor ID
- 081469
- Conditions
- Whiplash Injury of Cervical Spine, Muscle Weakness
- Keywords
- Whiplash Associated Disorders, Movement Coordination Deficits, McKenzie, Neck Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- D'Youville CollegeUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Nov 2023 (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.
The aim of this prospective observational study is to investigate whether the presence or absence of directional preference impacts movement coordination impairments as measured in patients with Whiplash Associated Disorders (WAD).
The primary research question this study aims to answer is:
- Is the presence of directional preference in patients with WADs associated with more favorable improvements in the specific outcome measures as compared to those patients with WADs without the presence of directional preference.
Patients in this study will asked to complete the following measures at baseline, during care, discharge, and 3 month follow up.
- Numeric Pain Rating Scale (NPRS)
- Optimal Screening for Prediction and Referral and Outcome-Yellow Flag (OSPRO-YF)
- Neck Disability Index (NDI)
- Craniocervical Flexion Test (CCFT)
- Neck Flexor Endurance Test
- Cervical Range of Motion
Patients demonstrating a directional preference will be managed utilizing a Mechanical Diagnosis and Treatment approach (MDT) while those without directional preference will be managed according to published clinical practice guidelines for patients with Neck Pain and Movement Coordination Deficits (WADs).
Detailed description
Objective The primary aim of this prospective observational study is to investigate whether the presence or absence of directional preference impacts movement coordination impairments as measured at the start of care, during care, discharge, and at 3 month follow up. It is hypothesized that the presence of directional preference in patients with WADs may be associated with more favorable improvements in the specific outcome measures as compared to the group without the presence of directional preference.
Design: Prospective Observation Cohort Design
Background: Neck pain ranks 19th in global disability-adjusted life years with an overall prevalence of 27 per 1000 population with variation based on geographic location amongst other factors. The clinical course of neck pain is variable and not always favorable. A research dearth remains in whiplash associated disorders (WAD) and movement coordination issues for the cervical spine.
Movement coordination impairments are commonly associated with whiplash associated disorders. Poorer prognosis is associated with older age, higher initial neck disability index, high initial pain intensity. Recovery slows down after the first 6-12 weeks, and some patients have with persistent pain and disability even 1 year after the whiplash associated disorder. However, the prognostic value of limited cervical mobility and altered motor control has also been questioned. The use of mechanical diagnosis and therapy (MDT) has been associated with better function, range of motion, and overall lower costs in whiplash associated disorders at both the 6 and 36 month mark but whether the results differ from natural history or other approaches is debatable.
Setting:
The settings for subject recruitment and all data collection are two outpatient physical therapy clinics located in the southeastern United States during the period of September 2023 to September 2024. Prior approval for data collection will be obtained in writing from the clinic directors of both sites.
Sample and Population:
Convenience sampling will be utilized for this study. A G-power a priori power analysis with a medium effect size determined that a sample size of 55 is required to achieve a statistical power of .80 with an alpha level of .05. A total of 65 subjects will be recruited between the two data collection sites to account for an expected 20% attrition rate on follow up.
Procedures: Subjects referred to one of two out-patient physical therapy clinics meeting inclusion criteria will be evaluated, classified using a Mechanical Diagnosis and Treatment (MDT) approach. Those patients demonstrating a directional preference will be managed using an MDT approach while those not demonstration a directional preference will be managed using published clinical practice guidelines for patients with Movement Coordination Deficits (WADs). Outcome measures will be taken at baseline, visit 5, visit 10 or discharge (whichever comes first) and 3 month follow up.
Data Analyses:
Descriptive statistics will be used to assess patient baseline and change scores on the dependent variables of interest. Inferential statistics (linear regression) will be utilized to assess for statistically significant changes over time and between groups for the variables of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whiplash Associated Disorder with Directional Preference | – | –Movements that reduce, abolish, or centralize the patient symptoms are recognized as a directional preference. Directional preference is ultimately used to guide the treatment of neck pain related to derangement syndrome.If the patient neck impairments are related to a Derangement syndrome, the patient will be instructed to perform the movements in the identified directional preference every 2-3 hours for 10-12 repetitions or to hold the cervical spine in a sustained position for 1-2 minutes. If the response to the intervention plateaus, the exercise intensity is progressed through the application of patient self-overpressure. If warranted clinician overpressure and mobilization may be utilized as a progression beyond patient generated forces. to achieve a favorable response. |
| Whiplash Associated Disorder without Direction Preference | – | –Patients with WADs that do not demonstrate directional preference will be managed based on the published Clinical Practice Guidelines (2017) for management of WADs with related movement coordination deficits. Treatment and progression of care for this group will be determined by the treating therapist but will consist of education, multimodal care inclusive of therapeutic exercise, mobilization, aerobic exercise, flexibility, and postural education. In addition, if the patient symptoms are chronic in nature treatment may include exercise progression, education and reassurance, transcutaneous nerve electrical stimulation, and cognitive behavioral therapy are recommended. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of interest for this study will consist of subjects meeting inclusion criteria referred by their physician to one of two out-patient physical therapy clinics located in the southwestern United States.
Key inclusion criteria (4 listed)
- Age 19-70
- Symptom complaints are related to a motor vehicle collision or trauma.
- Pain presents as unilateral or bilateral head/neck, upper back, or arm pain and/or stiffness
- Patient has been previously screened by their MD and received appropriate imaging to rule out the possibility of cervical fracture.
Key exclusion criteria (8 listed)
- Neck pain is determined to be of non-cervical origin
- Malignancy/infection
- Presence of progressive neurological deficits
- Cranial or cervical vascular disorder
- Substance use or withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Craniocervical Flexion Test (CCFT)
Time frame: Baseline, 3 weeks, 6 weeks
Measures the holding capacity of the deep cervical flexor muscles: longus capitis and longus coli.To measure the deficit, an inflatable pressure biofeedback device (Stabilizer, Chattanooga, Tennessee, USA) is placed behind the patient's neck while the patient is hook-lying in the supine position. The pressure sensor is inflated to a baseline pressure of 20 mmHg. The patient is then instructed to perform head nodding motions of craniocervical flexion. The patient is instructed to hold a head-nodding motion for ten seconds at a baseline of 20 mmHg. After this step, the patient's pressure is progressively increased by 2 mmHg in 10 second intervals until a maximum of 30 mmHg is achieved. If the patient failed to maintain the head-nodding position at a certain pressure, then the measurement is recorded.
Neck Flexor Endurance Test:
Time frame: Baseline, 3 weeks, 6 weeks
Used to measure the holding capacity of the deep cervical flexor muscles. The participant was instructed to tuck their chin, lift their head off the table, and hold that position until exhaustion, or onset of symptoms. The physical therapist administering the test used a stopwatch to assess duration of hold. The test was concluded if the patient demonstrated any of the following: protrusion, shaking, onset or worsening of symptoms, or touching the table with their head.18, neck pain versus no neck pain.
Cervical Range of Motion (CROM)
Time frame: Baseline, 3 weeks, 6 weeks
A standard goniometer will be used to measure patient range of motion for flexion, extension, side bending, and rotation. All measures will be completed in sitting and repeated two times in each direction. The standard error of measure for goniometry is 2.4 to 4.9 degrees
3 secondary outcomes
The Numerical Pain Rating System (NPRS)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months
Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months
The Neck Disability Index (NDI)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Results publication: PubMed 28666405Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
- Results publication: PubMed 27594661Ritchie C, Sterling M. Recovery Pathways and Prognosis After Whiplash Injury. J Orthop Sports Phys Ther. 2016 Oct;46(10):851-861. doi: 10.2519/jospt.2016.6918. Epub 2016 Sep 3.
- Results publication: PubMed 25827122Ritchie C, Hendrikz J, Jull G, Elliott J, Sterling M. External validation of a clinical prediction rule to predict full recovery and ongoing moderate/severe disability following acute whiplash injury. J Orthop Sports Phys Ther. 2015 Apr;45(4):242-50. doi: 10.2519/jospt.2015.5642.
- Results publication: PubMed 29932871Garcia AN, Costa LDCM, de Souza FS, de Almeida MO, Araujo AC, Hancock M, Costa LOP. Reliability of the Mechanical Diagnosis and Therapy System in Patients With Spinal Pain: A Systematic Review. J Orthop Sports Phys Ther. 2018 Dec;48(12):923-933. doi: 10.2519/jospt.2018.7876. Epub 2018 Jun 22.
- Results publication: PubMed 18804003Jull GA, O'Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. J Manipulative Physiol Ther. 2008 Sep;31(7):525-33. doi: 10.1016/j.jmpt.2008.08.003.
- Results publication: PubMed 21333948Domenech MA, Sizer PS, Dedrick GS, McGalliard MK, Brismee JM. The deep neck flexor endurance test: normative data scores in healthy adults. PM R. 2011 Feb;3(2):105-10. doi: 10.1016/j.pmrj.2010.10.023.
- Individual participant dataSharing planned: Undecided. If data is shared it would be deidentified data reported in aggregate format only.
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.
Jane Borgehammar, DSc study director
Midwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Whiplash Injury of Cervical Spine and Muscle Weakness, run by D'Youville College 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 4 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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Miller, DSc (7169129046, millere@dyc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craniocervical Flexion Test (CCFT) (time frame: Baseline, 3 weeks, 6 weeks). The study lists 3 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 NCT06143228, which also lists 6 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 22 Feb 2024.