NCT05000177

Brief Summary

Non-specific chronic neck pain (NCNP) is commonly seen in office workers. Individuals with NCNP not only demonstrate impaired neck movement control and muscle activation, but also show abnormal scapular kinematics and muscle activation timing. Office workers with NCNP also show higher activity of upper trapezius during computer typing and have difficulty relaxing upper trapezius after typing. These changes related to scapula may increase strain over neck. In addition to the altered neuromuscular control, recent studies found neuroplasticity changes in the central nervous system on patients of chronic musculoskeletal disorders. Therefore, few studies found shifts and alterations of motor cortex representation of neck muscles in individuals with NCNP, which was correlated with delayed muscle activation of deep neck flexors muscle in functional activities. However, no studies have explored that whether this corticospinal adaptation also happens over scapular muscles, especially after a computer typing task. The objectives of this proposal are to investigate the differences in corticospinal and neuromuscular control of shoulder complex between office workers with and without NCNP. Thirty-five individuals with NCNP and 35 healthy controls will be recruited. Twenty young healthy subjects will be also recruited for a pilot study to test the reliability of all the measures. Scapular kinematics and muscle activation will be tested during arm elevation. Corticospinal parameters of trapezius and serratus anterior will be tested with transcranial magnetic stimulation (TMS), including active motor threshold, motor evoked potential, cortical silent period, short interval intracortical facilitation, short interval intracortical inhibition and cortical mapping. Corticospinal parameters, except cortical mapping, will be measured again after a 30-minute computer typing task. Scapular muscle activation will be also recorded during the typing task.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 21, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

July 18, 2021

Last Update Submit

September 18, 2022

Conditions

Keywords

Non-specific chronic neck painTranscranial magnetic StimulationCorticospinal systemScapular kinematicsScapular muscles activation

Outcome Measures

Primary Outcomes (11)

  • Neurophysiological measures - Active motor threshold

    Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).

    Change from baseline AMT after 30-minute computer typing task or 30-minute rest

  • Neurophysiological measures - Motor evoked potential

    Motor evoked potential (MEP) will be described with millivolt (mV).

    Change from baseline MEP after 30-minute computer typing task or 30-minute rest

  • Neurophysiological measures - Cortical silent period

    Cortical silent period (CSP) will be measured with millisecond (ms)

    Change from baseline CSP after 30-minute computer typing task or 30-minute rest

  • Neurophysiological measures - Short interval cortical inhibition

    Short interval cortical inhibition (SICI) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is below 5 ms

    Change from baseline SICI after 30-minute computer typing task or 30-minute rest

  • Neurophysiological measures - Short interval cortical facilitation

    Short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms

    Change from baseline SICF after 30-minute computer typing task or 30-minute rest

  • Neurophysiological measures - Area of cortical mapping

    Area of cortical mapping will be described with square millimeter (mm2)

    Before 30-minute computer typing task

  • Neurophysiological measures - Volume of cortical mapping

    Volume of cortical mapping will be calculated with multiplying summation of motor evoke potentials on the map (mV) by the area of the map (mm2) with the unit of mV\*mm2

    Before 30-minute computer typing task

  • Neurophysiological measures - Center of gravity of cortical mapping

    Center of gravity of cortical mapping will be described in a x-y coordinate system (mm).

    Before 30-minute computer typing task

  • Neurophysiological measures - Area of cortical mapping

    Area of cortical mapping will be described with square millimeter (mm2)

    Change from baseline area of cortical mapping after 30-minute rest (pilot subjects)

  • Neurophysiological measures - Volume of cortical mapping

    Volume of cortical mapping will be calculated with multiplying summation of motor evoke potentials on the map (mV) by the area of the map (mm2) with the unit of mV\*mm2

    Change from baseline volume of cortical mapping after 30-minute rest (pilot subjects)

  • Neurophysiological measures - Center of gravity of cortical mapping

    Center of gravity of cortical mapping will be described in a x-y coordinate system (mm).

    Change from baseline center of gravity of cortical mapping of cortical mapping after 30-minute rest (pilot subjects)

Secondary Outcomes (9)

  • Scapular kinematics during arm elevation

    Before 30-minute computer typing task

  • Scapular kinematics during performing the computer task

    Change from baseline during the 30-minute computer typing task at 5, 10, 15, 20, 25, 30 minutes of the task

  • Scapular muscles activation during arm elevation

    Before 30-minute computer typing task

  • Scapular muscles activation during performing the computer task

    Change from baseline during the 30-minute computer typing task at 5, 10, 15, 20, 25, 30 minutes of the task

  • Craniovertebral angle

    Before 30-minute computer typing task

  • +4 more secondary outcomes

Study Arms (3)

Experimental group: Non-specific chronic neck pain group

OTHER

Subjects with non-specific chronic neck pain will be included to perform 30-minute computer typing task and assess neurophysiological measurements of scapular muscles, scapular kinematics and muscle activation.

Other: 30-minute computer typing task

Control group: Healthy subjects group

OTHER

Healthy subjects will be included to compare the differences in neurophysiological measurements of scapular muscles, scapular kinematics and muscle activation between healthy subjects and subjects with non-specific chronic neck pain. Subjects in this group will received the same assessment as the NCNP group.

Other: 30-minute computer typing task

Pilot study: Healthy subjects group

OTHER

Healthy subjects will be included to test reliability of single-pulse and paired-pulse TMS, including its associated neurophysiological measurements, and also to test reliability of Liberty electromagnetic tracing system and surface electromyography. Subjects in this group will received the same assessment as the NCNP group.

Other: 30-minute rest

Interventions

The subject sits in front of a computer screen and perform computer typing tasks for 30 minutes. The same computer table and chair were used for all subjects. The height of the table and screen, and the distance of the keyboard from the subject were adjusted according to their familiar and comfortable position.

Control group: Healthy subjects groupExperimental group: Non-specific chronic neck pain group

Rest for 30 minutes

Pilot study: Healthy subjects group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages ranges from 20-40 years old
  • Work with the computer at least 25 hours per week
  • Neck pain of idiopathic origin ≥ 6 months during the past year
  • Minimum of 3/10 on the numerical rating scale (NRS) in past 7 days
  • No structural abnormalities which are confirmed by neck X-ray or negative results of all the following special tests
  • Exclude nerve root compression: Cervical distraction test and Spurling's test
  • Exclude cervical radiculopathy: Valsalva test
  • Exclude cervical instability: Alar ligament test and Sharp-Purser test
  • Specific head movements or maintaining the fixed posture for a long time reproduced neck pain
  • Ages ranges from 20-40 years old
  • Work with the computer at least 25 hours per week
  • No history of neck and/or shoulder pain sustained over one week in the past one year
  • Ages ranges from 20-40 years old
  • No history of neck and/or shoulder pain sustained over one week in the past one year

You may not qualify if:

  • Any known pathology or impairment in the shoulder joint, which is the origin of neck pain
  • Current episode of neck pain related to a traumatic event (e.g., whiplash injury)
  • Have a history of cervical and/or shoulder pathology (e.g., fracture, dislocation, trauma, surgery of spinal or shoulder joint, inflammatory disease, frequent headache or dizziness)
  • Brain injury and neurological impairment (e.g., radiculopathy, myelopathy or stroke)
  • Systematic diseases (e.g., rheumatoid arthritis, ankylosing spondylitis), fibromyalgia, tumor
  • Contraindications to the use of transcranial magnetic stimulation (TMS), assessed with a safety screening questionnaire, including pregnancy, history of seizure, epilepsy and syncope, having cochlear implant, having medal implant and taking anti-depressant medication
  • Any kind of previous manual and/or movement therapy on upper extremity and neck during in recent 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

MeSH Terms

Interventions

RE1-silencing transcription factor

Study Officials

  • Yin-Liang Lin, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2021

First Posted

August 11, 2021

Study Start

December 21, 2021

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations