Influence of Directional Preference on Movement Coordination Deficits in Individuals With Whiplash Associated Disorders

Muscle Weakness Clinical Trial

Official title:

The Influence of Directional Preference on Movement Coordination Deficits in Individuals With Whiplash Associated Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143228
• Other study ID #: 081469
• Status: Recruiting
• Start date: December 30, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: D'Youville College
• Contact: Eric Miller, DSc
• Phone: 7169129046
• Email: millere[@]dyc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Whiplash Injuries
• Whiplash Injury of Cervical Spine

Locations

Country	Name	City	State
United States	Center for Orthopedic & Sports Physical Therapy	Tallahassee	Florida
United States	OrthoPT Spine & Joint Specialists Clinic	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
D'Youville College

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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: 10.2 — View 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. — View 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: — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 3 weeks, 6 weeks
Primary	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.	Baseline, 3 weeks, 6 weeks
Primary	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	Baseline, 3 weeks, 6 weeks
Secondary	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'.	Baseline, 3 weeks, 6 weeks, 3 months
Secondary	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	Baseline, 3 weeks, 6 weeks, 3 months
Secondary	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.	Baseline, 3 weeks, 6 weeks, 3 months