Pathophysiological Mechanism Behind Prolonged Whiplash Associated Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Balance test
研究概览
简要总结
The knowledge of pathophysiological mechanisms behind prolonged Whiplash Associated Disorders (WAD) is insufficient and whether changes can be restored by rehabilitation or not is unknown. The aim of these studies are to investigate different parameters to further learn about pathophysiological mechanisms (neck muscle fatty infiltration, cross-sectional area, volume, inflammation and function, brain structure and activity, biomarkers for stress and inflammation, cervical kinaesthesia and balance before and after intervention) and the association for clinical outcomes in individuals with chronic WAD (n=30) compared with age and gender matched healthy individuals (n=30). Measurements will be made at baseline (patients and healthy) and at 3 months (patients only, at the end of treatment). However, for the blood and saliva samples, they will be re-investigated in the healthy group as well. The study results may contribute to the development of improved understanding and diagnostics in chronic WAD that may improve future rehabilitation.
详细描述
BACKGROUND There is no consensus regarding the injury mechanism in complex prolonged Whiplash Associated Disorders (WAD) cases. Often, tissue damage and physiological alterations is not detectable. In order to improve future rehabilitation, a greater understanding of the mechanisms underlying whiplash injury and their importance for treatment success is required. It is also important to investigate if pathophysiological changes can be restored by rehabilitation.
AIM The projects aims to investigate neck muscle structure and function, biomarkers and the association with pain, disability and other outcomes before and after neck-specific exercises.
METHODS Design These are sub-group trials, each one independent of the others, in a prospective, multicentre, randomized controlled trial (RCT) with two parallel treatment arms conducted according to a protocol established before recruitment started (ClinicalTrials.gov Protocol ID: NCT03022812). Physiotherapist-led neck-specific exercise previously shown to be effective for the current population constitutes the control treatment for the new Internet-based neck-specific exercise treatment. In the RCT, a total of 140 patients will be included (70 from each group), whereof 30 (both randomization arms equally) consecutively will be asked to participate in the present sub-group study. The sub-group studies aims to start September 2019. Independent physiotherapists in primary health care will distribute the treatment.
In sub-group of individuals, additional measurements will be performed before and after interventions end (3 months follow-up). The physical measurements will be performed by independent specially trained test-leaders blinded to randomization.
Additionally, 30 neck healthy individuals without serious diseases matched for age and gender will consecutively be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor blinded if a patient or a healthy control
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study population
- •The inclusion criteria for patients are:
- •Chronic neck problems corresponding to WAD grades 2-3 verified by clinical examination
- •Average estimated pain in the last week at least 20 mm on the visual analogue scale (VAS)
- •Neck disability of more than 20% on the Neck Disability Index (NDI) [10]
- •Working age (18 - 63 years)
- •Daily access to a computer/tablet/smart phone and Internet
- •Neck symptoms within the first week after the injury (i.e., neck pain, neck stiffness, or cervical radiculopathy).
- •For the present sub group study additional criteria were:
- •Right handed
- •Dominant right sided or equal sided pain
- •Inclusion criteria for healthy controls:
- •Age and gender matched healthy individuals without neck pain and disability (VAS <10mm, NDI <5%) that feel overall healthy without known diseases.
排除标准
- •for patients:
- •Individuals with any of the following signs of head injury at the time of whiplash injury will be excluded: loss of consciousness, amnesia before or after the injury, altered mental status (e.g., confusion, disorientation), focal neurological changes (changes in smell and taste).
- •Previous fractures or dislocation of the cervical spine
- •Known or suspected serious physical pathology included myelopathy,
- •Spinal tumours
- •Spinal infection
- •Ongoing malignancy
- •Previous severe neck problems that resulted in sick leave for more than a month in the year before the current whiplash injury
- •surgery in the cervical spine
- •Generalized or more dominant pain elsewhere in the body
- •Other illness/injury that may prevent full participation
- •Inability to understand and write in Swedish
- •Additional criteria in the present sub group:
- •Increased risk of bleeding,
- •Contraindications of MRI such as metal, severe obesity, pacemaker and pregnancy.
- •Exclusion criteria for healthy controls:
- •Earlier neck injury,
- •Recurrent neck pain,
- •Earlier treatment for neck pain.
- •Increased risk of bleeding,
- •Contraindications of MRI such as metal, severe obesity, pacemaker and pregnancy.
结局指标
主要结局
Balance test
时间窗: Baseline, 3 months. The outcome measure is going to report a change over time for patients.
Postural sway during single and double leg stance
Speckle tracking analyses of neck and shoulder muscle function
时间窗: Baseline and at 3 months follow-up when intervention ended. The outcome measure is going to report a change over time for patients.
Measured with medical ultrasonography during neck and arm exercises
Cervikal kinaesthesia
时间窗: Baseline, 3 months. The outcome measure is going to report a change over time for patients.
Neck-eye coordination
Cross-sectional area, volume, fatty infiltration and inflammation of neck muscles
时间窗: Baseline, 3 months. The outcome measure is going to report a change over time for patients.
Neck and some whole body imaging measured with 3.0 T MRI scanner
Biomarkers for inflammation and stress
时间窗: Baseline, 3 months. The outcome measure is going to report a change over time for patients.
Measured with blood samples and saliva
Brain function in cortical networks related to pain
时间窗: Baseline, 3 months. The outcome measure is going to report a change over time for patients.
Measured with a resting-state fMRI protocol with an echo planar imaging (EPI) sequence
次要结局
- Dizziness/balance by the Dizziness Handicap Inventory (DHI)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Headache Questions by VAS and the Headache Impact Test (HIT-6)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Pain Catastrophizing Scale (PCS), total scores range from 0 - 52; 0=no catastrophizing, 52= maximum catastrophizing(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Whiplash Disability Questionnaire(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Use of pain medications(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- EuroQuol five dimensions(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Patient-specific functional scale (PSFS)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Symptoms Satisfaction scale(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Physical activity score, a combination score of the 2 questions (everyday physical activity and exercise/sport/open-air activity) to a combined 4-point score(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Health care consumption, number of visits(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Self-Efficacy Scale (SES)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Fear Avoidance Beliefs Questionnaire (FABQ)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Post Traumatic Stress Disorder checklist (PCL-S)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Range of neck motion(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Sickness presence by the Stanford presenteeism scale (SPS-6)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Sick-leave registration, number of days and episodes(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Neck Disability Index (NDI)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Pain intensity in neck, head, and arm and dizziness by a Visual Analogue Scale (VAS) (0-100 mm; where 0=no pain, 100= worst imaginable pain )(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Distribution of pain by a pain drawing assessed with images(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Frequency of pain(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Effort Reward Imbalance questionnaire(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Hospital Anxiety and Depression Scale (HAD)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Ergonomics questions and how work is perceived(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Cognitive failures questionnaire (CFQ)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Neck muscle endurance of ventral and dorsal neck muscles in seconds(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Balance measured in seconds, standing on one leg with eyes closed(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Patient Enablement Instrument (PEI) questionnaire(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Consumption of analgesic drugs prescribed through the drug registry(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Sensorimotor control of the neck muscles, mm Hg(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Global rating of change scale(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Neurology(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Work Ability Index (WAI)(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
研究者
Anneli Peolsson
Professor, PhD, PT
Linkoeping University