Clinical trial NCT06143228: Influence of Directional Preference on Movement Coordination Deficits in Individuals With Whiplash Associated Disorders
Official title: The Influence of Directional Preference on Movement Coordination Deficits in Individuals With Whiplash Associated Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Whiplash Injury of Cervical Spine
Muscle Weakness
Keywords: Whiplash Associated Disorders
Movement Coordination Deficits
McKenzie
Neck Pain
Lead sponsor: D'Youville College
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Craniocervical Flexion Test (CCFT)
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Neck Flexor Endurance Test:
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Cervical Range of Motion (CROM)
timeFrame: Baseline, 3 weeks, 6 weeks
Secondary outcomes:
measure: The Numerical Pain Rating System (NPRS)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months
measure: Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months
measure: The Neck Disability Index (NDI)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Center for Orthopedic & Sports Physical Therapy
state: Florida
city: Tampa
country: United States
facility: OrthoPT Spine & Joint Specialists Clinic
state: Florida
Study officials:
affiliation: Midwestern University
name: Jane Borgehammar, DSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.