Effectiveness of a Telerehabilitation Programme Based on Specific Neck Specific Neck Exercises in Patients With Whiplash-associated Disorders. Randomised Clinical Trial Controlled and Multicentric
概览
- 阶段
- 不适用
- 干预措施
- Usual care group
- 疾病 / 适应症
- Whiplash-associated Disorders
- 发起方
- Universidad de Concepcion
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Pain intensity as measured by Numeric Pain Rating Scale (NPRS)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
Whiplash-associated disorders (WAD) are common injuries from motor vehicle accidents, typically treated with a return to normal activity and neck exercises. The Spinetrack device has been approved for deep neck musculature training, but its impact on pain and disability in subacute WAD patients in a virtual setting hasn't been evaluated yet. This study aims to assess the effect of a telerehabilitation programme using the Spinetrack device on pain and self-perceived disability in subacute WAD I and II patients. The single-blinded, randomised, controlled clinical trial will involve 102 participants divided into three groups: a telerehabilitation group using Spinetrack, a group with a standard telerehabilitation programme, and a usual care group. Training will be conducted via video call for six weeks. The study expects to confirm that deep neck musculature training reduces pain and disability in WAD patients and establish Spinetrack as an efficient tool for subacute WAD treatment.
详细描述
Introduction: Whiplash-associated disorders (WAD) are a group of clinical manifestations experienced by individuals following a sudden acceleration-deceleration mechanism of the neck. WAD are the most common injuries resulting from a motor vehicle accident. The mainstays of WAD treatment are a return to normal activity and both general and deep neck musculature exercises. Recently, a device called Spinetrack has been validated to facilitate training of the deep craniocervical musculature. This device can even be adapted for use in a virtual format. However, to date, it has not been determined how this device contributes to the improvement of pain and disability in individuals with subacute WAD in a virtual context. Objective: The aim of this study is to evaluate the effect of a telerehabilitation programme, which is based on specific neck exercises with the Spinetrack, on pain and self-perceived disability in people with WAD I and II in the subacute stage. Methods: This study is a single-blinded, randomised, controlled clinical trial. A total of 102 subjects with WAD I and II will be recruited according to the Quebec Task Force classification in the subacute stage. The participants will be randomised into three groups: a telerehabilitation group based on specific neck exercises with the Spinetrack (SES), a treatment group with a telerehabilitation programme with standard specific neck exercises (SSE), and a usual care group (UCG). Training will be carried out via video call over 12 sessions distributed over six weeks, with two sessions per week. The main outcome variables will be pain and perceived disability. Expected Results: The investigators anticipate that training the deep neck musculature will reduce pain and disability in patients with WAD. It is expected to demonstrate the device's function as a tool for self-management of neck symptoms and to provide the health care system with an efficient device for the treatment of subacute WAD.
研究者
Mario Muñoz Bustos
Associate professor
Universidad de Concepcion
入排标准
入选标准
- •Age between 18-65 years
- •Patients with WAD, defined as cervical pain or disability resulting from a resulting from a collision or similar trauma, grade I-II according to QTF8 in subacute stage from 7 days to 12 weeks.
- •Have internet connection and a device to communicate (telephone, television, computer).
- •NPRS up to moderate category (4 out of 10).38
- •IDC score up to moderate category (15 out of 50).
排除标准
- •Screening for cervical fractures ruled out by the National Emergency X-ray Utilization Study (NEXUS) criteria. (Focal neurological deficits such as paralysis, paraesthesia, speech, vision or hearing impairment; Midline spinal cord tenderness; Altered spinal cord level Altered level of consciousness; Intoxication; Distraction injury defined as a serious injury to another part of the body; or other serious injury to another part of the body that could distract from the neck injury).
- •Previous cervical spine, jaw and upper extremity surgeries
- •Traumatic brain injury
- •Neck pain and disability from abuse, domestic violence or fights
- •Difficulty hearing and understanding instructions
研究组 & 干预措施
Usual care group
This group will receive instructions from the doctor based on their assessment, taking into account education and analgesics
Specific neck exercises with the Spinetrack
Exercise the deep neck muscles using the Spinetrak twice a week for 6 weeks.
Standard specific neck exercises
Exercise programme for the deep neck musculature twice a week for 6 weeks.
结局指标
主要结局
Pain intensity as measured by Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, at 6 and 12 weeks
NPRS is a validated instrument assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no pain) to (wort possible pain).
Disability as measured by Neck disability Index (NDI)
时间窗: Baseline, at 6 and 12 weeks
This questionnaire has been validated to give information as to how the neck pain has affected the ability to manage in everyday life.The original report provided scoring intervals for interpretation, as follows: 0 to 4 = no disability 5 to 14 = mild 15 to 24 = moderate 25 to 34 = severe Above 34 = complete.
次要结局
- Global Perceived Effect as measured by Global Perceived Effect Scale (-7 to +7 Likert Scale)(Baseline, at 6 and 12 weeks)
- Self-perception of vestibular difficulty as measured by Dizziness Handicap Inventory (DHI)(Baseline, at 6 and 12 weeks)
- dizziness induced by dynamic visual input as measured by Visual vertigo analogue scale (VVAS)(Baseline, at 6 and 12 weeks)
- Impact of headaches on daily life Headache intensity as measured by The Headache Impact Test (HIT-6)(Baseline, at 6 and 12 weeks)
- Fear or excessive aversion to physical movement or exercise, also called kinesiophobia as measured by Tampa Scale of Kinesiophobia (TSK)(Baseline, at 6 and 12 weeks)
- depression and anxiety as measured by Hospital Anxiety and Depression Scale (HADS)(Baseline, at 6 and 12 weeks)
- Difficulties people sometimes have after stressful life events as measured by Impacto of event scale (IES)(Baseline, at 6 and 12 weeks)
- Measures the somatic and emotional symptoms common to central sensitization syndrome (CSS) as measured by the Central Sensitization Inventory (CSI)(Baseline, at 6 and 12 weeks)