Back to resultsThe Effect of Adding Auditory Information on Head Movements in People With Traumatic Neck Pain
Primary Purpose
Whiplash, Healthy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Smartphone playing a sound
Sponsored by
About this trial
This is an interventional basic science trial for Whiplash focused on measuring Whiplash, Neck pain, Kinematics
Eligibility Criteria
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
Sites / Locations
- FysioDanmark Aalborg
- Dept. Of Health Science and Technology, Aalborg University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Sound 1
Sound 2
No Sound
Arm Description
A sound will be played while moving the head
A sound (different from Sound 1) will be played while moving the head
No sound will be played while moving the head
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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).
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06028308
Brief Title
The Effect of Adding Auditory Information on Head Movements in People With Traumatic Neck Pain
Official Title
The Effect of Adding Auditory Information on Head Movements in People With Traumatic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 31, 2023 (Anticipated)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash, Healthy
Keywords
Whiplash, Neck pain, Kinematics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sound 1
Arm Type
Experimental
Arm Description
A sound will be played while moving the head
Arm Title
Sound 2
Arm Type
Experimental
Arm Description
A sound (different from Sound 1) will be played while moving the head
Arm Title
No Sound
Arm Type
No Intervention
Arm Description
No sound will be played while moving the head
Intervention Type
Device
Intervention Name(s)
Smartphone playing a sound
Intervention Description
A sound will be played from a portable device (smartphone mounted with earphones) during movement
Primary Outcome Measure Information:
Title
Range of motion
Description
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)
Time Frame
During a single test session (approximately 45minutes) at day 1
Secondary Outcome Measure Information:
Title
Head repositioning accuracy
Description
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.
Time Frame
During a single test session (approximately 45minutes) at day 1
Title
Quality of head movement
Description
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).
Time Frame
During a single test session (approximately 45minutes) at day 1
Title
Perceived stiffness during movement
Description
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.
Time Frame
During a single test session (approximately 45minutes) at day 1
Title
Perceived difficultness of performing movement
Description
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
Time Frame
During a single test session (approximately 45minutes) at day 1
Title
Perceived neck pain intensity
Description
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
Time Frame
During a single test session (approximately 45minutes) at day 1
Other Pre-specified Outcome Measures:
Title
Neck Disability Index (NDI)
Description
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
Time Frame
At the beginning of the single test session (approximately 45minutes) at day 1
Title
Tampa Scale for Kinesiophobia (TSK-11)
Description
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
Time Frame
At the beginning of the single test session (approximately 45minutes) at day 1
Title
Perceived area of neck pain
Description
Participants will draw the area of perceived neck pain on a body chart
Time Frame
At the beginning of the single test session (approximately 45minutes) at day 1
Title
Fear Avoidance Beliefs Questionnaire-physical activity subscale (FABQpa)
Description
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
Time Frame: At the beginning of the single test session (approximately 45minutes) at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steffan WM Christensen, PhD
Phone
(+45) 99408889
Email
stc@hst.aau.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffan WM Christensen, PhD
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
FysioDanmark Aalborg
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Dept. Of Health Science and Technology, Aalborg University
City
Gistrup
ZIP/Postal Code
9260
Country
Denmark
12. IPD Sharing Statement
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The Effect of Adding Auditory Information on Head Movements in People With Traumatic Neck Pain
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