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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Whiplash
• Intervention / Treatment: Device: Smartphone playing a sound

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: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	During a single test session (approximately 45minutes) at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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	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	During a single test session (approximately 45minutes) at day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index (NDI)	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)	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	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)	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

• Sponsor: Aalborg University
• Investigators: Principal Investigator: Steffan WM Christensen, PhD, Aalborg University

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Neck pain; Whiplash; Kinematics
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Neck Injuries; Neck Pain; Whiplash Injuries
• Other Study ID 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