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Alterations in Central Control of Shoulder Muscles in Office Workers With Non-specific Chronic Neck Pain

Primary Purpose

Non-specific Chronic Neck Pain, Office Workers, Transcranial Magnetic Stimulation

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

30-minute computer typing task

30-minute rest

About this trial

This is an interventional other trial for Non-specific Chronic Neck Pain focused on measuring Non-specific chronic neck pain, Transcranial magnetic Stimulation, Corticospinal system, Scapular kinematics, Scapular muscles activation

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria of Patients with Non-specific Chronic Neck Pain

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

Inclusion Criteria of Healthy Subjects in the control group

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

Inclusion Criteria of Healthy subjects in the Pilot Study

Ages ranges from 20-40 years old
No history of neck and/or shoulder pain sustained over one week in the past one year

Exclusion Criteria of Patients with Non-specific Chronic Neck Pain and All Healthy Subjects)

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

Sites / Locations

National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Experimental group: Non-specific chronic neck pain group

Control group: Healthy subjects group

Pilot study: Healthy subjects group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Neurophysiological measures - Active motor threshold

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

Neurophysiological measures - Motor evoked potential

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

Neurophysiological measures - Cortical silent period

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

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

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

Neurophysiological measures - Area of cortical mapping

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

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

Neurophysiological measures - Center of gravity of cortical mapping

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

Neurophysiological measures - Area of cortical mapping

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

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

Neurophysiological measures - Center of gravity of cortical mapping

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

Secondary Outcome Measures

Scapular kinematics during arm elevation

Scapular kinematics, including anterior/posterior tilt, upward/downward rotation, and internal/external rotation in scapula plane elevation at 30°, 60°, 90°, and 120°, and will be described with degree (°).

Scapular kinematics during performing the computer task

The average of scapular kinematics, including anterior/posterior tilt, upward/downward rotation, and internal/external rotation will be calculated with a window of 10 seconds and will be described with degree (°).

Scapular muscles activation during arm elevation

The root mean square of electromyography (EMG) data of the upper trapezius, lower trapezius, and serratus anterior will be normalized by the maximum voluntary contraction amplitude (percentage of maximal voluntary contraction, %) and calculated over three 30° increments of motion during arm elevation from 30° to 120°, including 30° - 60°, 60° - 90°, and 90° - 120°.

Scapular muscles activation during performing the computer task

The root mean square of electromyography (EMG) data of the upper trapezius, lower trapezius, and serratus anterior will be calculated with a window of 10 seconds and will be normalized by the maximum voluntary contraction amplitude (percentage of maximal voluntary contraction, %).

Craniovertebral angle

Craniovertebral angle will be measured as the included angle between the tragus, C7 spinous process and the horizontal line and will be described with degree (°)

Craniovertebral angle

Craniovertebral angle will be measured as the included angle between the tragus, C7 spinous process and the horizontal line and will be described with degree (°)

Scapular kinematics during arm elevation

Scapular muscles activation during arm elevation

Craniovertebral angle

Craniovertebral angle will be measured as the included angle between the tragus, C7 spinous process and the horizontal line and will be described with degree (°)

Full Information

NCT ID

NCT05000177

First Posted

July 18, 2021

Last Updated

September 18, 2022

Sponsor

National Yang Ming University

1. Study Identification

Unique Protocol Identification Number

NCT05000177

Brief Title

Alterations in Central Control of Shoulder Muscles in Office Workers With Non-specific Chronic Neck Pain

Official Title

Alterations in Corticospinal and Neuromuscular Control of Shoulder Complex in Office Workers With Non-specific Chronic Neck Pain

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

December 21, 2021 (Actual)

Primary Completion Date

May 13, 2022 (Actual)

Study Completion Date

May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-specific Chronic Neck Pain, Office Workers, Transcranial Magnetic Stimulation, Neuromuscular Control

Keywords

Non-specific chronic neck pain, Transcranial magnetic Stimulation, Corticospinal system, Scapular kinematics, Scapular muscles activation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group: Non-specific chronic neck pain group

Arm Type

Other

Arm Description

Arm Title

Control group: Healthy subjects group

Arm Type

Other

Arm Description

Arm Title

Pilot study: Healthy subjects group

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

30-minute computer typing task

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

30-minute rest

Intervention Description

Rest for 30 minutes

Primary Outcome Measure Information:

Title

Neurophysiological measures - Active motor threshold

Description

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

Time Frame

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

Title

Neurophysiological measures - Motor evoked potential

Description

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

Time Frame

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

Title

Neurophysiological measures - Cortical silent period

Description

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

Time Frame

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

Title

Neurophysiological measures - Short interval cortical inhibition

Description

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

Time Frame

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

Title

Neurophysiological measures - Short interval cortical facilitation

Description

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

Time Frame

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

Title

Neurophysiological measures - Area of cortical mapping

Description

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

Time Frame

Before 30-minute computer typing task

Title

Neurophysiological measures - Volume of cortical mapping

Description

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

Time Frame

Before 30-minute computer typing task

Title

Neurophysiological measures - Center of gravity of cortical mapping

Description

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

Time Frame

Before 30-minute computer typing task

Title

Neurophysiological measures - Area of cortical mapping

Description

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

Time Frame

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

Title

Neurophysiological measures - Volume of cortical mapping

Description

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

Time Frame

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

Title

Neurophysiological measures - Center of gravity of cortical mapping

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Scapular kinematics during arm elevation

Description

Time Frame

Before 30-minute computer typing task

Title

Scapular kinematics during performing the computer task

Description

Time Frame

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

Title

Scapular muscles activation during arm elevation

Description

Time Frame

Before 30-minute computer typing task

Title

Scapular muscles activation during performing the computer task

Description

Time Frame

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

Title

Craniovertebral angle

Description

Craniovertebral angle will be measured as the included angle between the tragus, C7 spinous process and the horizontal line and will be described with degree (°)

Time Frame

Before 30-minute computer typing task

Title

Craniovertebral angle

Description

Craniovertebral angle will be measured as the included angle between the tragus, C7 spinous process and the horizontal line and will be described with degree (°)

Time Frame

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

Title

Scapular kinematics during arm elevation

Description

Time Frame

Change from baseline scapular kinematics after 30-minute rest (pilot subjects)

Title

Scapular muscles activation during arm elevation

Description

Time Frame

Change from baseline scapular muscles activation after 30-minute rest (pilot subjects)

Title

Craniovertebral angle

Description

Craniovertebral angle will be measured as the included angle between the tragus, C7 spinous process and the horizontal line and will be described with degree (°)

Time Frame

Change from baseline craniovertebral angle after 30-minute rest (pilot subjects)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria of Patients with Non-specific Chronic Neck Pain 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 Inclusion Criteria of Healthy Subjects in the control group 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 Inclusion Criteria of Healthy subjects in the Pilot Study Ages ranges from 20-40 years old No history of neck and/or shoulder pain sustained over one week in the past one year Exclusion Criteria of Patients with Non-specific Chronic Neck Pain and All Healthy Subjects) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yin-Liang Lin, PhD

Organizational Affiliation

National Yang Ming University

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Yang-Ming University

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

12. IPD Sharing Statement

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Alterations in Central Control of Shoulder Muscles in Office Workers With Non-specific Chronic Neck Pain

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