WhiplashNCT06028308
The Effect of Adding Auditory Information on Head Movements in People With Traumatic Neck Pain
A study testing Smartphone playing a sound in people with Whiplash and Healthy, run by Aalborg University at 2 sites in Denmark.
Trial summary
This study sets out to investigate the potential effect of auditory disturbances on human movement Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Smartphone playing a sound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesDenmark
- Study dates
- 31 Aug 2023to 30 Sep 2026
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to speak, read and understand Danish/English
- Traumatic onset of neck pain
- Able to speak, read and understand Danish/English
- Reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion
Who cannot join
- Pain from the neck or shoulder area during the past 6 months
- Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
- Former surgery in neck or shoulder
- Current or previous chronic or recurrent pain condition that could affect the results
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
Show all 18Show fewer
- Previous neurologic, musculoskeletal or mental illnesses that could affect the results
- Regular use of analgesics
- Abnormally disrupted sleep in the last 24 hours preceding the experiment
- Lack of ability to cooperate
- Neck pain group:
- Experience of DOMS during the week leading up to the test session
- Former surgery in neck or shoulder
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal (other than neck pain) or mental illnesses that could affect the results
- Abnormally disrupted sleep in the 24 hours preceding the experiment
- Lack of ability to cooperate
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
FysioDanmark Aalborg
Aalborg, 9000
Dept. Of Health Science and Technology, Aalborg University
Gistrup, 9260
About this study
This study sets out to investigate the potential effect of auditory disturbances on human movement
Read the detailed description
Clinicians routinely investigate/test human movement but if/how this is effect by auditory disturbances is unclear. This study sets out to investigate the impact of auditory disturbances on head movements.
- Being tested
- Smartphone playing a sound
- Keywords
- Whiplash, Neck pain, Kinematics
- Medical subject headings
- Whiplash Injuries, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone playing a soundDevice
A sound will be played from a portable device (smartphone mounted with earphones) during movement
| Study group | Role | What they receive |
|---|---|---|
| Sound 1 | Experimental | A sound will be played while moving the head Receives: Device: Smartphone playing a sound |
| Sound 2 | Experimental | A sound (different from Sound 1) will be played while moving the head Receives: Device: Smartphone playing a sound |
| No Sound | No intervention | No sound will be played while moving the head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Range of motion will be assessed during head rotations (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position)
Measured: During a single test session (approximately 45minutes) at day 1
Secondary outcomes (5)
Head repositioning accuracy
Head repositioning accuracy will be assessed as the error between the starting point and the end point following a head rotation (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position) and will be repressed in degrees.
Measured: During a single test session (approximately 45minutes) at day 1
Quality of head movement
Quality of movement (smoothness) will be determined using calculations of jerk variance (Jerk is the time derivative of acceleration which will be measures using an inertial measurement unit. The measure will be converted to a unitless measure where higher values indicates less smooth movements), assessed during head rotations (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position).
Measured: During a single test session (approximately 45minutes) at day 1
Perceived stiffness during movement
Participants will rate their perceived stiffness during head movement using a 0-100 numerical rating scale, where 0 = no stiffness and 100 = worst stiffness imaginable.
Measured: During a single test session (approximately 45minutes) at day 1
Perceived difficultness of performing movement
Participants will rate the Perceived difficultness of performing head movements using a 6-point Likert scale going from 0 = no problems, 1 = minimally difficult; 2 = somewhat difficult; 3 = fairly difficult; 4 = very difficult; 5 = unable to perform
Measured: During a single test session (approximately 45minutes) at day 1
Perceived neck pain intensity
Participants will rate ant potential pain during the session using a 0-11 numeric rating scale (NRS) with 0 = no pain and 10 = worst imaginable pain
Measured: During a single test session (approximately 45minutes) at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start31 Aug 2023 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WhiplashStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffan Wittrup Christensen, Aalborg University
- Investigators
- Steffan WM Christensen, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028308
- Sponsor's protocol ID
- AAU031-1025976b
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Auditory Information on Head Movements in People With Traumatic Neck Pain
- ClinicalTrials.gov ID
- NCT06028308
- Acronym / sponsor ID
- AAU031-1025976b
- Keywords
- Whiplash, Neck pain, Kinematics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 31 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Sep 2023 (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.
This study sets out to investigate the potential effect of auditory disturbances on human movement
Detailed description
Clinicians routinely investigate/test human movement but if/how this is effect by auditory disturbances is unclear. This study sets out to investigate the impact of auditory disturbances on head movements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sound 1 | Experimental | Device: Smartphone playing a soundA sound will be played while moving the head |
| Sound 2 | Experimental | Device: Smartphone playing a soundA sound (different from Sound 1) will be played while moving the head |
| No Sound | No intervention | –No sound will be played while moving the head |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to speak, read and understand Danish/English
- Traumatic onset of neck pain
- Able to speak, read and understand Danish/English
- Reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion
Key exclusion criteria (18 listed)
- Pain from the neck or shoulder area during the past 6 months
- Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
- Former surgery in neck or shoulder
- Current or previous chronic or recurrent pain condition that could affect the results
- Pregnancy
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 |
|---|---|---|
| Smartphone playing a soundA sound will be played from a portable device (smartphone mounted with earphones) during movement | Device | Sound 1, Sound 2 |
Primary outcome
Range of motion
Time frame: During a single test session (approximately 45minutes) at day 1
Range of motion will be assessed during head rotations (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position)
5 secondary outcomes
Head repositioning accuracy
Time frame: During a single test session (approximately 45minutes) at day 1
Quality of head movement
Time frame: During a single test session (approximately 45minutes) at day 1
Perceived stiffness during movement
Time frame: During a single test session (approximately 45minutes) at day 1
Perceived difficultness of performing movement
Time frame: During a single test session (approximately 45minutes) at day 1
Perceived neck pain intensity
Time frame: During a single test session (approximately 45minutes) at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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.
Steffan WM Christensen, PhD principal investigator
Aalborg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone playing a sound in people with Whiplash and Healthy, run by Aalborg University at 2 sites in Denmark.
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 4 inclusion and 18 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
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?
Contact Steffan WM Christensen, PhD ((+45) 99408889, stc@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: During a single test session (approximately 45minutes) at day 1). 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 8 Sep 2023.