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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06028308
Other study ID # AAU031-1025976b
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 31, 2023
Est. completion date September 30, 2026

Study information

Verified date August 2023
Source Aalborg University
Contact Steffan WM Christensen, PhD
Phone (+45) 99408889
Email stc@hst.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark FysioDanmark Aalborg Aalborg
Denmark Dept. Of Health Science and Technology, Aalborg University Gistrup

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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