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临床试验/NCT06143228
NCT06143228招募中不适用

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

D'Youville College2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
65
试验地点
2
主要终点
Craniocervical Flexion Test (CCFT)

研究概览

简要总结

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).

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Craniocervical Flexion Test (CCFT)

时间窗: 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.

Cervical Range of Motion (CROM)

时间窗: 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

Neck Flexor Endurance Test:

时间窗: 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.

次要结局

  • The Neck Disability Index (NDI)(Baseline, 3 weeks, 6 weeks, 3 months)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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