Clinical trial NCT06474130: Assessing Cervical Sensorimotor Control With VR in Chronic Neck Pain
Official title: Cervical Sensorimotor Control Assessment Using a Virtual Reality System in Individuals With and Without Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neck Pain
Virtual Reality
Sensorimotor
Keywords: Sensorimotor control
Virtual Reality
Chronic neck Pain
cervical
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2024-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CNP will be recruited from the affiliated hospital, local outpatient clinics, local communities and around the campus.

Healthy adults will be recruited from the local communities near the university in the Tainan city.

Brief summary: To develop a cervical SMC VR assessment system incorporating different SMC tests and to compare cervical SMC performance using this self-developed VR assessment system in individuals with and without CNP


Eligibility criteria: Inclusion Criteria:

1. For patients with chronic neck pain:

   * Pain was unilateral or bilateral between the superior nuchal line and 1st thoracic vertebra,
   * Neck pain persisting for 3 months and above,
   * Average pain intensity of last pain episode was between 2 and 8 based on the numerical rating scale (NRS)
2. Healthy asymptomatic adults:

   * Do not have any complaints of current pain and impairments of neuromusculoskeletal systems within the last 6 months

Exclusion Criteria:

* acute or the first onset of neck pain
* previous fracture or surgery of the spine
* diagnosed cardiopulmonary diseases, for example, chronic obstructive pulmonary disease, pulmonary tuberculosis, asthma, chronic bronchitis, pulmonary emphysema
* diagnosed gastrointestinal and abdominal conditions which may interfere daily activities within the past 6 months
* medical conditions that may affect balance and study procedures (e.g. neurological diseases, vestibular disorders, malignant tumors)
* metabolic diseases such as anemia and diabetes
* smoking, plan to pregnant or in pregnancy
* psychological disorders (affect questionnaire responses)
* unable to walk independently
* Corrected visual abnormalities or individuals unable to wear contact lenses for vision correction due to the potential interference of wearing VR head-mounted display with glasses

Primary outcomes:
measure: Cervical Range of Motion (ROM)
timeFrame: One day
measure: Joint Position Error (JPE)
timeFrame: One day
measure: Figure of Eight (FOE)
timeFrame: One day
measure: Subjective Visual Vertical (SVV)
timeFrame: One day
measure: Head Tile Response (HTR)
timeFrame: One day
measure: Saccades
timeFrame: One day
measure: Smooth Pursuit Neck Torsion (SPNT)
timeFrame: One day
measure: Postural Sway (PS)
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References: