Influence of Directional Preference on Movement Coordination Deficits in Individuals With Whiplash Associated Disorders
NCT ID: NCT06143228
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
65 participants
OBSERVATIONAL
2023-12-30
2024-12-30
Brief Summary
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The primary research question this study aims to answer is:
1\. 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.
1. Numeric Pain Rating Scale (NPRS)
2. Optimal Screening for Prediction and Referral and Outcome-Yellow Flag (OSPRO-YF)
3. Neck Disability Index (NDI)
4. Craniocervical Flexion Test (CCFT)
5. Neck Flexor Endurance Test
6. 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).
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
19 Years
70 Years
ALL
Yes
Sponsors
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D'Youville College
OTHER
Responsible Party
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Principal Investigators
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Jane Borgehammar, DSc
Role: STUDY_DIRECTOR
Midwestern University
Locations
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Center for Orthopedic & Sports Physical Therapy
Tallahassee, Florida, United States
OrthoPT Spine & Joint Specialists Clinic
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Ritchie 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.
Ritchie 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.
Garcia 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.
Jull 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.
Domenech 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.
Other Identifiers
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081469
Identifier Type: -
Identifier Source: org_study_id
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