Is E-health a Way to Increase Ability and Health and Make Health Care More Effective in Chronic Whiplash? A Prospective Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
Neck pain is fourth among the most common conditions worldwide associated with longer periods of living with disability. Annually, about 30 000 people in Sweden undergo a whiplash trauma (WAD), and half of those individuals will develop chronic problems with high costs for the individual and society. Evidence for chronic WAD treatment is scarce, although neck-specific training at a physiotherapy clinic (2 times a week for 3 months) has demonstrated good results. A more efficient, flexible rehabilitation with reduced waiting times and lower costs is needed, ideally replacing lengthy on-site treatment series by health care providers. Internet-based care has proven to be a viable alternative to personal care meetings for a variety of diseases and interventions, but studies are lacking on Internet-based interventions for individuals with chronic neck problems. The purpose of this study is to investigate if A) neck-specific training delivered through Internet-based care differs from B) a longer series of treatments at a physiotherapy clinic regarding, e.g., work ability, sick-leave and disability. This prospective, randomized study involves 140 participants. Measurement is done at baseline, 3 months (end of treatment), and 15 months (12 months after end of treatment in the study) and will include ratings of work ability, sick-leave, work presenteeism, disability, pain, health, satisfaction with care, quality of life, and cost-effectiveness. The study results may contribute to the development of a more effective rehabilitation, flexible and equal care, shorter waiting times, increased availability and lower costs for health care and society. The program can be implemented on a broader scale in neck pain patients.
详细描述
The purpose of the study is to investigate if the effect of neck-specific exercises in people with chronic WAD (at risk for or at sick-leave) differs based on distribution via Internet-based care in combination with three visits (+ a first examination visit due to Swedish law) to the physiotherapist compared to a longer series (2 times/week for 3 months, i.e., 24 times + a first visit) of exercises at the physiotherapy clinic. Outcomes are for instance work ability, sick-leave, physical and psychological disability, pain, quality of life, satisfaction with treatment, and cost effectiveness. Further objectives are to a) describe the level of work ability, work presenteeism, and sick leave; b) determine which factors are related to a good work ability; c) identify factors predictive of a favourable outcome regarding work ability, disability, and pain; and d) describe how the participants perceived an Internet-based rehabilitation.
Hypothesis: Internet-based support combined with a few (three) physiotherapist visits has an equivalent effect to a longer exercise period (24 times) at a physiotherapist clinic and yields lower economic costs for society.
Design This is an experimental, longitudinal, prospective, multicentre randomized controlled trial (RCT) with two treatment arms. Treatment that has previously been shown to be effective (neck-specific exercises guided by a physiotherapist and performed at the physiotherapist clinic) for the current population constitutes the control treatment for the new Internet-based neck-specific exercise treatment. A total of 140 people are expected to be included, 70 in each group (sample size estimated by statisticians). Independent physiotherapists in primary care clinical practice will distribute the treatment. The project manager will not be a test leader.
Recruitment and randomization Interested patients will contact the research team (experienced physiotherapists), and after a small survey filled in by the potential participant, a project team member will perform a telephone interview, ask about the medical history, and perform a physical examination to ensure that criteria for study participation are met. If the study criteria are met and after written and oral informed consent of the patient, the patient will fill out a questionnaire (baseline data) and undergo physical measurements of neck-related function. Baseline measurements must be completed for inclusion.
The patient will be randomized through a computerized randomization list (block randomization conducted by a statistician, stratification by gender) to one of two groups of 3 months of treatment with neck-specific exercises: A) exercises at a physiotherapy clinic 2 times/week for 3 months; or B) Internet-based support exercises in combination with four visits to the physiotherapist. The test leader is blinded for group allocation. The randomization is performed by an independent researcher not otherwise involved in any of the test or treatments. The researcher sends an opaque envelope containing the name and contact details of the patient and information about the randomization group to the treating physiotherapist, who calls the patient to a new clinical examination (by law) before treatment can start. Due to the nature of the study neither participants nor treating therapists can be blinded, however all tests are done by blinded test leaders. Data collection in the form of questionnaires and tests of physical neck-related function occurs at baseline (before randomization) and after 3 months (when the treatment ends) and 15 months (12 months after completion of the intervention in the project). The treating physiotherapists will receive oral and written information and a day of practical training. The treating physiotherapist is also able to consult with the project managers at any time if necessary. An exercise diary is maintained by patients in both groups, and the number of care contacts is recorded by the physiotherapist. Seventy people per group, i.e., a total of 140 participants with chronic WAD grades 2 and 3, will be recruited.
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
- Single (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
- •Individuals with a whiplash injury in a traffic accident with a four-wheeled motor vehicle at least 6 months ago but less than 5 years ago, with chronic neck problems corresponding to Quebec Task Force (QTF) grades 2-3 verified in clinical examination
- •No participation in a neck-specific exercise program in a previous research study;
- •Average estimated pain in the preceding week more than 20 mm on the visual analogue scale (VAS)
- •Neck disability for more than 20% of the Neck Disability Index
- •Working age, between 18 and 63 years
- •Daily access to computer/tablet/smart phone and Internet
- •Time to follow the treatment program
- •Neck symptoms within the first week after the injury (neck pain, neck stiffness, or radiculopathy from the neck).
排除标准
- •Any of the following signs of brain damage at the time of injury: 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 column
- •Known or suspected serious physical pathology included myelopathy, spinal tumours, spinal infection, or 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 column
- •Generalized or more dominant pain elsewhere in the body
- •Other illness/injury that may prevent full participation in the study and/or where neck exercises are contraindicated
- •Inability to understand and write in Swedish
- •Diagnosed severe mental illness, e.g., psychosis, schizophrenia, personality disorders
- •Current alcohol or drug abuse.
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up
Self-reported neck-specific function
次要结局
- 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)
- 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)
- Pain intensity in neck, head, and arm and dizziness by a VAS (0-100 mm)(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)
- 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)
- 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(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)
- 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)
- 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)
- Hospital Anxiety and Depression Scale(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)(Baseline)
- 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)
- 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)
- Sickness presence by the Stanford presenteeism scale(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)
- 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)
- 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)
- 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)
- 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)
- Neurology such as reflexes, sensibility, muscle weakness, Spurling´s test, neural tension test(Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up)
- Ultrasound registrations may be measured in a sub-group, deformation and deformation rate(Change from baseline to 3 months follow-up)
- MRI may be measured in a sub-group.(Change from baseline to 3 months follow-up)
研究者
Anneli Peolsson
Professor, PhD, PT
Linkoeping University