Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
NCT Number: NCT06580990
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Whiplash-associated Disorders
Interventions: PROCEDURE: specific neck exercises with the Spinetrack|PROCEDURE: specific neck exercises
Sponsor: Universidad de Concepcion
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-05
Locations: Universidad de Concepción, Concepción, Región Del Bío-Bío, 4070312, Chile

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.

Primary Outcome Measures: Pain intensity as measured by Numeric Pain Rating Scale (NPRS), 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)., Baseline, at 6 and 12 weeks|Disability as measured by Neck disability Index (NDI), 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., Baseline, at 6 and 12 weeks
Secondary Outcome Measures: Global Perceived Effect as measured by Global Perceived Effect Scale (-7 to +7 Likert Scale), The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter. Patients are routinely asked to make global ratings on changes in regards to their level of well-being since the previous week's treatment on a 15-point self-report scale (from -7 to 7), Baseline, at 6 and 12 weeks|Self-perception of vestibular difficulty as measured by Dizziness Handicap Inventory (DHI), The DHI is a 25-item self-reported measure with three categories: functional, emotional, and physical. The patient rates their perceived disability due to their dizziness by answering each question with - yes, sometimes, or no., Baseline, at 6 and 12 weeks|dizziness induced by dynamic visual input as measured by Visual vertigo analogue scale (VVAS), Vertigo symptoms that are triggered by visual stimuli. Scale have 9 items and each one is answered from 0 (no vertigo) to 10 (maximum vertigo)., Baseline, at 6 and 12 weeks|Impact of headaches on daily life Headache intensity as measured by The Headache Impact Test (HIT-6), HIT-6 is a questionnaire for measuring the impact of headache. A total of six questions are completed by the patient. They focus on daily activities such as work, education, home situation and leisure time. The HIT-6 gives a general overview of the impact of headache, including pain intensity, impairment and other items. A higher score corresponds to higher impact., 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), The TSK is a 17 item assessment checklist. It uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury, Baseline, at 6 and 12 weeks|depression and anxiety as measured by Hospital Anxiety and Depression Scale (HADS), The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21), Baseline, at 6 and 12 weeks|Difficulties people sometimes have after stressful life events as measured by Impacto of event scale (IES), Post-traumatic stress disorder (PTSD) symptoms. Event Impact Scale-Revised has 22 items and 3 subscales: Intrusion, Avoidance and Hyperarousal. It uses a Likert-type scale to evaluate the intensity of the of the symptomatology (0,1,2,2,3,4. From 'Not at all' to 'Extremely').

to 'Extremely'), 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), Pathophysiologic process in which the central nervous system undergoes changes that alter its processing of pain and other sensory stimuli, may be the mechanism underlying various conditions in which patients have unexplained pain and fatigue. The CSI consists of two parts; Part A includes 25 questions related to common CSS symptoms. Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression., Baseline, at 6 and 12 weeks|How the neck pain affects the ability to function in everyday life as measured by the Neck OutcOme Score (NOOS), the Neck OutcOme Score (NOOS) is a reliable, valid, and responsive measure of self-reported disability in neck pain patients. The scale contains 34 items and takes 10-15 min to complete. It is divided into subdomains: 'Mobility'; 'Stiffness'; 'Symptoms'; 'Sleep disorders'; 'Daily Activities and Pain'; 'Participation in everyday life'; and 'Quality of life'. The patient assigns a score from 0 to 5 for each question, with 0 being no problems and 5 being the highest level of difficulty or pain., Baseline, at 6 and 12 weeks