The Effect of Adding Auditory Information on Head Movements in People With Traumatic Neck Pain

August 31, 2023 updated by: Steffan Wittrup Christensen, Aalborg University
This study sets out to investigate the potential effect of auditory disturbances on human movement

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Steffan WM Christensen, PhD
  • Phone Number: (+45) 99408889
  • Email: stc@hst.aau.dk

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • FysioDanmark Aalborg
      • Gistrup, Denmark, 9260
        • Dept. Of Health Science and Technology, Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Control group:

Inclusion Criteria (Control):

  • Able to speak, read and understand Danish/English

Exclusion Criteria (Control):

  • 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
  • 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:

Inclusion Criteria (Neck Pain):

  • 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

Exclusion Criteria (Neck Pain):

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sound 1
A sound will be played while moving the head
Device: Smartphone playing a sound
A sound will be played from a portable device (smartphone mounted with earphones) during movement
Experimental: Sound 2
A sound (different from Sound 1) will be played while moving the head
Device: Smartphone playing a sound
A sound will be played from a portable device (smartphone mounted with earphones) during movement
No Intervention: No Sound
No sound will be played while moving the head

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
During a single test session (approximately 45minutes) at day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Head repositioning accuracy
Time Frame: During a single test session (approximately 45minutes) at day 1
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.
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
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).
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
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.
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
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
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
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
During a single test session (approximately 45minutes) at day 1

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neck Disability Index (NDI)
Time Frame: At the beginning of the single test session (approximately 45minutes) at day 1
The NDI questionnaire consists of 10 items (Domains: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, recreation) used to assess how neck pain affects your ability to manage everyday activities. Each item is score on a scale from 0-5 with a higher total score = high level of disability
At the beginning of the single test session (approximately 45minutes) at day 1
Tampa Scale for Kinesiophobia (TSK-11)
Time Frame: At the beginning of the single test session (approximately 45minutes) at day 1
The TSK-11 questionnaire consists of 11 items which is answered using a 4-point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Score can range from 11 to 44 and a higher score indicated a greater kinesiophobia
At the beginning of the single test session (approximately 45minutes) at day 1
Perceived area of neck pain
Time Frame: At the beginning of the single test session (approximately 45minutes) at day 1
Participants will draw the area of perceived neck pain on a body chart
At the beginning of the single test session (approximately 45minutes) at day 1
Fear Avoidance Beliefs Questionnaire-physical activity subscale (FABQpa)
Time Frame: Time Frame: At the beginning of the single test session (approximately 45minutes) at day 1
The FABQpa subscale consists of 4 items which are used to assess the participants beliefs on how physical activity can affect their pain. The items are scored on a 7-point scale with 0 = Completely disagree and 6 = Completely agree. Score ranges from 0-24 with a higher score indicating higher fear avoidance beliefs with regards to physical activity
Time Frame: At the beginning of the single test session (approximately 45minutes) at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steffan WM Christensen, PhD, Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAU031-1025976b

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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