NCT06143228

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. 1.Numeric Pain Rating Scale (NPRS)
  2. 2.Optimal Screening for Prediction and Referral and Outcome-Yellow Flag (OSPRO-YF)
  3. 3.Neck Disability Index (NDI)
  4. 4.Craniocervical Flexion Test (CCFT)
  5. 5.Neck Flexor Endurance Test
  6. 6.Cervical Range of Motion

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

November 16, 2023

Last Update Submit

February 20, 2024

Conditions

Keywords

Whiplash Associated DisordersMovement Coordination DeficitsMcKenzieNeck Pain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • The Numerical Pain Rating System (NPRS)

    Baseline, 3 weeks, 6 weeks, 3 months

  • Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF)

    Baseline, 3 weeks, 6 weeks, 3 months

  • The Neck Disability Index (NDI)

    Baseline, 3 weeks, 6 weeks, 3 months

Study Arms (2)

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.

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Orthopedic & Sports Physical Therapy

Tallahassee, Florida, 32308, United States

RECRUITING

OrthoPT Spine & Joint Specialists Clinic

Tampa, Florida, 33613, United States

RECRUITING

Related 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.

  • 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.

MeSH Terms

Conditions

Muscle WeaknessNeck Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPain

Study Officials

  • Jane Borgehammar, DSc

    Midwestern University

    STUDY DIRECTOR

Central Study Contacts

Eric Miller, DSc

CONTACT

Jane Borgehammar, DSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

December 30, 2023

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations