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Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.

U

Universidad de Concepcion

Status

Enrolling

Conditions

Whiplash-associated Disorders

Treatments

Procedure: specific neck exercises with the Spinetrack
Procedure: specific neck exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT06580990
CEBB 1682-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

102 participants in 3 patient groups

Specific neck exercises with the Spinetrack
Experimental group
Description:
Exercise the deep neck muscles using the Spinetrak twice a week for 6 weeks.
Treatment:
Procedure: specific neck exercises with the Spinetrack
Standard specific neck exercises
Active Comparator group
Description:
Exercise programme for the deep neck musculature twice a week for 6 weeks.
Treatment:
Procedure: specific neck exercises
Usual care group
No Intervention group
Description:
This group will receive instructions from the doctor based on their assessment, taking into account education and analgesics

Trial contacts and locations

1

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Central trial contact

María A RodríguezTastets, PhD; María D RodríguezTastets, PhD

Data sourced from clinicaltrials.gov

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