Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.

NCT06580990 | Recruiting

• 1 other identifier: CEBB 1682-2024
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash-associated Disorders

Keywords

Whiplash; Exercise; Pain; Disability; Telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (3)

Specific neck exercises with the Spinetrack

EXPERIMENTAL

Exercise the deep neck muscles using the Spinetrak twice a week for 6 weeks.

Procedure: specific neck exercises with the Spinetrack

Standard specific neck exercises

ACTIVE COMPARATOR

Exercise programme for the deep neck musculature twice a week for 6 weeks.

Procedure: specific neck exercises

Usual care group

NO INTERVENTION

This group will receive instructions from the doctor based on their assessment, taking into account education and analgesics

Interventions

specific neck exercises with the Spinetrack PROCEDURE

This group will receive an telerehabilitation exercise programme for the deep neck musculature using the spinetrack

Also known as: SES

Specific neck exercises with the Spinetrack

specific neck exercises PROCEDURE

This group will receive a telerehabilitation programme with exercise for the deep neck musculature

Also known as: SSE

Standard specific neck exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Concepcion: lead

Study Sites (1)

Universidad de Concepción

Concepción, Región del Biobío, 4070312, Chile

RECRUITING

MeSH Terms

Conditions

Whiplash Injuries; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mario Muñoz Bustos, MSc

  Universidad de Concepcion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María D RodríguezTastets, PhD

CONTACT

+56412204302; andrea@udec.cl

María A RodríguezTastets, PhD

CONTACT

+56412204302; andrea@udec.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the evaluator does not have access to the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This study will be a single-blinded, randomised, controlled clinical trial and multicentric

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: October 29, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)