Clinical trial NCT06580990: Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Official title: Effectiveness of a Telerehabilitation Programme Based on Specific Neck Specific Neck Exercises in Patients With Whiplash-associated Disorders. Randomised Clinical Trial Controlled and Multicentric
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Whiplash-associated Disorders
Keywords: Whiplash
Exercise
Pain
Disability
Telerehabilitation
Lead sponsor: Universidad de Concepcion
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a single-blinded, randomised, controlled clinical trial and multicentric
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain intensity as measured by Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, at 6 and 12 weeks
measure: Disability as measured by Neck disability Index (NDI)
timeFrame: Baseline, at 6 and 12 weeks
Secondary outcomes:
measure: Global Perceived Effect as measured by Global Perceived Effect Scale (-7 to +7 Likert Scale)
timeFrame: Baseline, at 6 and 12 weeks
measure: Self-perception of vestibular difficulty as measured by Dizziness Handicap Inventory (DHI)
timeFrame: Baseline, at 6 and 12 weeks
measure: dizziness induced by dynamic visual input as measured by Visual vertigo analogue scale (VVAS)
timeFrame: Baseline, at 6 and 12 weeks
measure: Impact of headaches on daily life Headache intensity as measured by The Headache Impact Test (HIT-6)
timeFrame: Baseline, at 6 and 12 weeks
measure: Fear or excessive aversion to physical movement or exercise, also called kinesiophobia as measured by Tampa Scale of Kinesiophobia (TSK)
timeFrame: Baseline, at 6 and 12 weeks
measure: depression and anxiety as measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, at 6 and 12 weeks
measure: Difficulties people sometimes have after stressful life events as measured by Impacto of event scale (IES)
timeFrame: Baseline, at 6 and 12 weeks
measure: Measures the somatic and emotional symptoms common to central sensitization syndrome (CSS) as measured by the Central Sensitization Inventory (CSI)
timeFrame: Baseline, at 6 and 12 weeks
Other outcomes:
Locations:
city: Concepción
country: Chile
facility: Universidad de Concepción
state: Región Del Bío-Bío
Study officials:
affiliation: Universidad de Concepcion
name: Mario Muñoz Bustos, MSc
role: PRINCIPAL_INVESTIGATOR
References: