Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.

NCT ID: NCT06580990

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2026-07-30

Brief Summary

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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

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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.

Conditions

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Whiplash-associated Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a single-blinded, randomised, controlled clinical trial and multicentric
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
the evaluator does not have access to the intervention

Study Groups

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Specific neck exercises with the Spinetrack

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

Group Type EXPERIMENTAL

specific neck exercises with the Spinetrack

Intervention Type PROCEDURE

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

Standard specific neck exercises

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

Group Type ACTIVE_COMPARATOR

specific neck exercises

Intervention Type PROCEDURE

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

Usual care group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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specific neck exercises with the Spinetrack

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

Intervention Type PROCEDURE

specific neck exercises

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

Intervention Type PROCEDURE

Other Intervention Names

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SES SSE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Concepcion

OTHER

Sponsor Role lead

Responsible Party

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Mario Muñoz Bustos

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Muñoz Bustos, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad de Concepcion

Locations

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Universidad de Concepción

Concepción, Región del Biobío, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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María D RodríguezTastets, PhD

Role: CONTACT

+56412204302

María A RodríguezTastets, PhD

Role: CONTACT

+56412204302

Facility Contacts

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mario e muñoz bustos, MSc

Role: primary

+56956878264 ext. +56412207312

mario e muñoz bustos, MSc

Role: backup

956878264 ext. 2207116

Other Identifiers

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CEBB 1682-2024

Identifier Type: -

Identifier Source: org_study_id

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