The Effect of Adding Auditory Information on Head Movements in People With Non-traumatic Neck Pain

Healthy Clinical Trial

Official title:

The Effect of Adding Auditory Information on Head Movements in People With Non-traumatic Neck Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06028269
• Other study ID #: AAU031-1025976a
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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):

• Idiopathic 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

Related Conditions & MeSH terms

• Healthy
• Neck Pain

Intervention

Device:
• Smartphone playing a sound
A sound will be played from a portable device (smartphone) 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