Neck DisorderPhase 2/3NCT04201483
Real-time Ultrasound Imaging as Feedback for Deep Cervical Extensors Activation
A Phase 2/3 study testing DCE without RUSI feedback and DCE + RUSI feedback about performance in people with Neck Disorder, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Disorder
- What is being tested?
- DCE without RUSI feedback and DCE + RUSI feedback about performance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2019to 20 Apr 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No actual neck pain
- Being able to understand Spanish language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physiotherapy. University of Valencia
Valencia, 46010
Fernando Dominguez, Pt, (+34) 608 592 581, fernando.dominguez@uv.es
Enrique Lluch Girbes, Pt, PhD
About this study
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
Read the 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.
- Conditions
- Neck Disorder
- Being tested
- DCE without RUSI feedback, DCE + RUSI feedback about performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCE without RUSI feedbackOther
Participants assigned to this group will perform an exercise known to selectively activate the semispinalis cervicis muscle
DCE + RUSI feedback about performanceOther
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
| Study group | Role | What they receive |
|---|---|---|
| DCE group | Active comparator | DCE exercise without RUSI feedback Receives: Other: DCE without RUSI feedback |
| DCE + RUSI group | Experimental | DCE exercise with RUSI feedback Receives: Other: DCE + RUSI feedback about performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From baseline to one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start5 Dec 2019
- Primary completion20 Feb 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck DisorderStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized clinical trial, with parallel groups and a blinded assessor performed in accordance with CONSORT guidelines. Participants will be randomized into two exercise groups: "DCE exercise without RUSI feedback (DCE)" and "DCE exercise with RUSI feedback (DCE+RUSI)". Randomization will be conducted using computer-generated random numbers (Epidat® version 3.1). Allocation concealment will be ensured using opaque and sealed envelopes
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201483
- Sponsor's protocol ID
- 1574447392087
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Ultrasound Imaging as Feedback for Deep Cervical Extensors Activation
- ClinicalTrials.gov ID
- NCT04201483
- Acronym / sponsor ID
- 1574447392087
- Conditions
- Neck Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 20 Feb 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a randomized clinical trial, with parallel groups and a blinded assessor performed in accordance with CONSORT guidelines. Participants will be randomized into two exercise groups: "DCE exercise without RUSI feedback (DCE)" and "DCE exercise with RUSI feedback (DCE+RUSI)". Randomization will be conducted using computer-generated random numbers (Epidat® version 3.1). Allocation concealment will be ensured using opaque and sealed envelopes
| Arm | Type | Receives |
|---|---|---|
| DCE group | Active comparator | Other: DCE without RUSI feedbackDCE exercise without RUSI feedback |
| DCE + RUSI group | Experimental | Other: DCE + RUSI feedback about performanceDCE exercise with RUSI feedback |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No actual neck pain
- Being able to understand Spanish language
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCE without RUSI feedbackParticipants assigned to this group will perform an exercise known to selectively activate the semispinalis cervicis muscle | Other | DCE group |
| DCE + RUSI feedback about performanceParticipants 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 | Other | DCE + RUSI group |
Primary outcome
Deep cervical extensors function at baseline
Time frame: 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
Change of the deep cervical extensors function from baseline to immediately after intervention
Time frame: 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
Change of the deep cervical extensors function from baseline to one week after intervention
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Physiotherapy. University of Valencia
Valencia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DCE without RUSI feedback and DCE + RUSI feedback about performance in people with Neck Disorder, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep cervical extensors function at baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.