Real-time Ultrasound Imaging as Feedback for Deep Cervical Extensors Activation

The aim of this study will be to determine the value of adding real-time ultrasound imaging (RUSI) as an external feedback tool for teaching the contraction of the deep cervical extensors (DCE) in healthy subjects. The potential benefit of RUSI to facilitate activation of the DCE during a specific motor task as well as the retention capacity of this motor task after a short period of training will be investigated

Study Overview

• Status: Unknown
• Conditions: Neck Disorder
• Intervention / Treatment: Other: DCE without RUSI feedback; Other: DCE + RUSI feedback about performance

Detailed Description

Participants will be randomly allocated into two exercise groups: "DCE exercise without RUSI feedback (DCE)" and "DCE exercise with RUSI feedback (DCE+RUSI)".

Participants assigned to DCE will perform an exercise known to selectively activate the semispinalis cervicis muscles. By the other hand, participants in the DCE+RUSI group will perform the same exercise as the DCE group to selectively activate the semispinalis cervicis muscle but receiving RUSI feedback about correct performance. In both groups, a total of 10 sets of 10 repetitions will be performed with one minute of rest between each set.

Ultrasound measurement will be used to asses the antero-posterior dimension (thickness) of the DCE both at rest and during contraction at the level of C4 at baseline, immediately after the DCE exercise activation protocol and one-week follow-up in order to evaluate retention capacity.

All participants will be asked to not perform any other cervical motor control exercise or exercise using RUSI feedback until the last time point assessment will be finished.

All participants will be asked to avoid any exercises or treatments for neck pain between sessions.

All ultrasound images will be analysed off-line using Image J software. Thickness and percent thickness change will be measured. The percent thickness change will be calculated by using the following equation: thickness contracted - thickness rest / thickness rest.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • Faculty of Physiotherapy. University of Valencia
    • Contact: Fernando Dominguez, Pt; Phone Number: (+34) 608 592 581; Email: fernando.dominguez@uv.es
    • Principal Investigator: Enrique Lluch Girbes, Pt, PhD
    • Sub-Investigator: Fernando Dominguez Navarro, Pt
    • Sub-Investigator: Jose Manuel Martinez De la Fuente, Pt
    • Sub-Investigator: Jochen Schomacher, Pt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No actual neck pain
• Being able to understand Spanish language

Exclusion Criteria:

• Neck pain in the last 3 months
• Previous surgery in the neck region
• Neurological diseases or any other condition that may alter voluntary muscle contraction
• Previous experience with cervical motor control training exercises
• Previous experience using RUSI as an external feedback tool in any other body area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DCE group; DCE exercise without RUSI feedback	Other: DCE without RUSI feedback; Participants assigned to this group will perform an exercise known to selectively activate the semispinalis cervicis muscle
Experimental: DCE + RUSI group; DCE exercise with RUSI feedback	Other: DCE + RUSI feedback about performance; Participants in this group will perform the same exercise as the DCE group to selectively activate the semispinalis cervicis muscle but receiving RUSI feedback about correct performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deep cervical extensors function at baseline	Ultrasound measurements will be used to asses the antero-posterior dimension (thickness) of the deep cervical extensors both at rest and during contraction at the level of C4	Baseline
Change of the deep cervical extensors function from baseline to immediately after intervention	Ultrasound measurements will be used to asses the antero-posterior dimension (thickness) of the deep cervical extensors both at rest and during contraction at the level of C4	From baseline to immediately after intervention
Change of the deep cervical extensors function from baseline to one week after intervention	Ultrasound measurements will be used to asses the antero-posterior dimension (thickness) of the deep cervical extensors both at rest and during contraction at the level of C4	From baseline to one week after intervention

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Anticipated): February 20, 2020
• Study Completion (Anticipated): April 20, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1574447392087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No