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NCT Number: NCT06028308

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

This study sets out to investigate the potential effect of auditory disturbances on human movement

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Key information

Conditions

Whiplash Healthy Neck Injuries Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Whiplash Injuries Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FysioDanmark Aalborg, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone playing a sound

Device

A sound will be played from a portable device (smartphone mounted with earphones) during movement

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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

  5. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Steffan WM Christensen, PhD

CONTACT

[email protected]

(+45) 99408889

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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