Rehabilitation for Whiplash Associated Disorders; a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Neck disability index (NDI)
研究概览
简要总结
Individuals (n=180) with subacute (<1 month, >3 months) WAD grade I and II with medium to high-risk symptoms of working age will be randomized into three groups with block randomization in a prospective, assessor-blinded randomized controlled trial. Two primary intervention groups (A and B) will receive manual therapy (MT) in the same out-patient clinic. In addition, group A will receive a remote, novel, computer-based cervical kinaesthetic exercise program starting at visit two, whereby quality and quantity of exercise performance, as well as compliance (frequency and duration), will be registered into the physical therapy clinic's system for evaluation. Group B will receive neck exercises (not computer-based) provided by the corresponding physical therapist. Group A will continue remote exercise therapy until 6 months post baseline measurements regardless of whether they are still being treated in-clinic or discharged.
Hypothesis 1.a.: Internet-based neck-specific CKE combined with in-clinic manual therapy and exercises will be superior to manual therapy and exercises alone at a physiotherapy clinic (i.e., treatment A is superior to treatment B) for self-reported and measured (movement performance) outcome measures.
Hypothesis 1.b.: Improvements in self-reported outcomes will positively correlate with outcomes of movement performance testing, as will the pre- to post-intervention changes from baseline to follow-up assessments.
The groups will be compared to a "treatment as usual" group (C). Objective measures include measurements for motor control, proprioception, and cervical range of motion. Neck disability and pain intensity, general health, self-perceived handicap, and physical, emotional and functional difficulties due to dizziness will be measured using questionnaires. Short-term effects will be measured at 10-12 weeks and long-term effects at 6- and 12-months post baseline measurements.
Hypothesis 2.a.: Participants of groups A and B will improve significantly more than those in group C for subjective and objective outcome measures.
详细描述
QUALITY ASSURANCE PLAN:
PhD student will monitor the data and guarantee high data quality. Data will be protected according to the Act on Data Protection and the Processing of Personal data (Icelandic law) and stored at the University Hospital or at a secure NeckCare database. Data will be registered into Microsoft Excel and shared through a secure network with other researchers to promote transparency.
DATA CHECKS:
Data will be checked for outliers.
SOURCE DATA VERIFICATION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subacute (>1 month, <3 months) neck problems corresponding to WAD grades I-II verified by WhipPredict
- •medium to high risk symptoms (NDI score >32% OR subject is >36 years old) OR VAS score >4/10
- •within daily reach of a computer/tablet/smartphone and Internet
- •showed neck symptoms within the first week following the car collision (i.e. neck pain, neck stiffness)
排除标准
- •WAD grades III-IV
- •considerable degree of known or suspected physical pathology (Myelopathy, Spinal tumours, Spinal infection, Ongoing malignancy, Cervical spine surgery, Severe neck problems within their medical history which resulted in sick leave for more than a month in the year before the current whiplash injury, Other illness/injury that may prevent full participation from being feasible, Lack of ability to either understand or write Icelandic, Severe obesity (body mass index; BMI > 35), Pregnancy)
- •unable to complete the assessment
结局指标
主要结局
Neck disability index (NDI)
时间窗: 5 minutes
the NDI is a 10-item self-report questionnaire that has been shown to demonstrate good validity and reliability. Each section is scored on a 0 to 5 rating scale, higher score represents more neck pain related disability.
Whole Cervical Range of Motion (ROM) Test
时间窗: 5 minutes
* Procedure: The subject turns their head using four different types of movements: flexion, extension, rotation (left/right) and lateral flexion (left/right) to measure the maximum range ROM. Each movement is repeated 3 times. * Metrics: An average degree value and standard deviation of the 3 measurements for each movement type.
Head Neck Relocation Test (HNRT)
时间窗: 5 minutes
* Procedure: While blindfolded, the subject is asked to find their "neutral" position. The subject then turns their head to rotate left/right and up/down and attempts to return to the neutral/initial position following each movement, the subject informs the researcher by saying a simple "ok" when he believes he has reached the neutral position. The researcher marks this with one mouse click. * Metrics: (1) Accuracy Error measures the deviation in degrees from the initial position; (2) Constant Error measures under-/overshooting; and (3) Variable Error measures the precision of the head posture.
Visual Analog Scale (VAS)
时间窗: 1 minutes
Neck pain intensity during the past week prior to each measurement measured by a 100 mm visual analogue scale (VAS) with 0mm representing "no pain" and 100mm representing "worst pain imaginable
Butterfly Test
时间窗: 5 minutes
* Procedure: The subject tracks an unpredictable path as accurately as possible using head movement to manipulate the on-screen cursor. There are different trajectories with increasing difficulty. The subject repeats each trajectory path 3 times. * Metrics: (1) Amplitude Accuracy (AA): the absolute distance (radius) in mm between the cursor that represents the head position and the target. (2) Time On Target (ToT): the percentage of time the cursor that represents the head position spends in a mathematically determined, invisible free zone around the target. (3) Smoothness of Movement Index (SMI): The index is calculated based on the third positional derivative with respect to time and is scaled between 0 and 5 with 0 being the best and 5 being the worst.
次要结局
- Dizziness Handicap Inventory (DHI)(5 minutes)
- Central Sensitization Inventory (CSI)(5 minutes)
- SF-36 Health Survey (SF-36) RAND version(10 minutes)