Ignite Creation Date:
2024-05-06 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05146960
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2021-10-29
Brief Title:
Relation Between Temporal Summation and Fatigue
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
The Effect of Evoked Temporal Summation in the Lateral Elbow Region on Cervical Muscle Endurance and Fatigue Characteristics
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Central sensitization CS is a common feature in chronic musculoskeletal pain conditions including rheumatoid arthritis chronic whiplash syndrome fibromyalgia temporomandibular joint disorders low back pain and lateral elbow pain CS is defined as an amplification of neural signaling within the central nervous system that elicits pain hypersensitivity Clinical signs are allodynia hyperalgesia and widespread pain originating from the enhanced activity of central nervous system to peripheral afferent input from unimodal and polymodal receptors
CS not only induces abnormal pain processing it may also lead to motor performance dysfunction in chronic pain population CS induce cortical reorganization including changes in gray matter cortical representation and cortical excitability both in motor and somatosensory cortex This process ultimately generates sensorimotor conflict that described as a mismatch between motor intention and sensory feedback and may directly effect on motor performance The structural changes in basal ganglia and reduced GABAergic activity in the motor cortex contribute to the alteration of the motor performance It has been known that CS and fatigue another indicator of the motor performance has a bidirectional effect and fatigue is predicted by CS independently of the presence of pain CS affect fatigue via causing disrupted reward process increased effort and pain expactation
The increased cervical spine hypersensitivity in patients with LEP even if there is no accompanied neck or upper limb pain may also indicate of the fatigue as pain does not always suggest an injury and biomechanical damage to a tissue does not always suggest that an individual will experience pain If neck muscle fatigue is effected by central sensitization in patients with LEP it can be important to develop therapeutic strategies to prevent neck muscle fatigue as there is a relationship between fatigue and increased risk of injury Despite the fact that central sensitization effect on neck pain has been well documented in patients with LEP its role on fatigue had not gain enough clinical and research attention To know about central sensitization effect on motor performance can also be useful for determine subgroup of population who have central sensitization However it is unknown whether remote body endurance alteration occur in lateral elbow pain or not
CS not only induces abnormal pain processing it may also lead to motor performance dysfunction in chronic pain population CS induce cortical reorganization including changes in gray matter cortical representation and cortical excitability both in motor and somatosensory cortex This process ultimately generates sensorimotor conflict that described as a mismatch between motor intention and sensory feedback and may directly effect on motor performance The structural changes in basal ganglia and reduced GABAergic activity in the motor cortex contribute to the alteration of the motor performance It has been known that CS and fatigue another indicator of the motor performance has a bidirectional effect and fatigue is predicted by CS independently of the presence of pain CS affect fatigue via causing disrupted reward process increased effort and pain expactation
The increased cervical spine hypersensitivity in patients with LEP even if there is no accompanied neck or upper limb pain may also indicate of the fatigue as pain does not always suggest an injury and biomechanical damage to a tissue does not always suggest that an individual will experience pain If neck muscle fatigue is effected by central sensitization in patients with LEP it can be important to develop therapeutic strategies to prevent neck muscle fatigue as there is a relationship between fatigue and increased risk of injury Despite the fact that central sensitization effect on neck pain has been well documented in patients with LEP its role on fatigue had not gain enough clinical and research attention To know about central sensitization effect on motor performance can also be useful for determine subgroup of population who have central sensitization However it is unknown whether remote body endurance alteration occur in lateral elbow pain or not
Detailed Description:
EMG assessment Electrode Placement Before electrode placement the skin will be cleaned with alcohol to reduce skin impedance
Sternocleidomastoid Muscle SCM Electrode Placement Electrodes will be placed to the the sternal head of the SCM while participants were sitting in a erect position A line will be drawn from the sternal notch to the mastoid process and marked at 13 of the distance from the sternal notch Electrodes initially will placed adjacent to the this point with 20 mm apart and over the muscle belly based on the muscle palpation during manually resisted neck flexion contractions This location is anticipated to place between the innervation zone and the tendon In supine the head will be placed in a neutral anatomic position that craniocervical and cervical spine is in a mid position It will be ensured visually by examiner that cervical spine is in the neutral position which means from the middle of the subjects forehead to the middle of the chin is horizontal and a line bisecting the neck longitudinally is parallel to the treatment plinth Participants will asked to completely relax in this position For normalization isometric neck flexor contraction will be carried out in supine position via applying manual resistance on frontal region by gradually increasing force that reached maximum force level in 2 second and then contracted maximally for 5 second This procedure will be repeated 3 times with a 30 second time interval
Upper Trapezius UT Muscle Electrode Placement Electrodes will be attached 20 laterally to the midpoint between the dorsal processes of C4 and the posterior lateral third of the clavicle For normalization manual resistance will be given neck extensor while participant lying in prone position Contraction will be lasted 5 second for 3 times with 30 interval
After electrode placement a 5 seconds rest recording will be performed for eliminating basal noise from recording During the endurance test participants will asked not to cough laugh or talk and head position will be controlled by inclinometer adapted to EMG system Participants will be given 3 minutes resting time between neck flexorextensor endurance tests for the experimental group
Neck Flexor Endurance Test An examiner will place her hand under the occiput of the participant while the participant is lying in supine position with the knees bend and the arms resting on the abdomen Cranicervical flexion will be taught to the participants For this participants will asked to place tongue on roof of the mouth with lips together and teeth slightly apart while cervical spine is in neutral position Participants will not be allowed to open mouth during the test Participants will be requested to perform gentle head nodding as if saying yes via sliding head in caudal and cephalic directions on the bed and concentrate feeling of back of the head After learning of the craniocervical flexion the participant will be requested to head off from the examiners hand approximately 25 cm from the plint vhile maintaining the craniocervical flexion and then sustain this position as long as possible The holding time will be recorded with a stopwatch The test will be ended once the participant is unable to hold their head in a correct position that chances occur more than 5 degree for more than one second can no longer maintain craniocervical flexion or head position due to fatigue
Neck Extensor Endurance Test Participants will be asked to lie in a prone position maintaining thoracal extension with a strap at the level of T6 arms in their side and head is end of the plinth The subjects head and neck will be positioned in a comfortable neutral position with the chin retracted 2 kg weight will be placed around the participants head Participants will be asked to sustain this position as long as possible after removing support from the head The test will be ended when the participant can no longer sustain a correct position or when the head position changes more than 5 degrees The holding time will be recorded with a stopwatch
Experimental group
Experimental pain induction Temporal Summation Then participants will be asked to seat in a comfortable position placing their volar faces of the tested dominant arm in elbow flexion on a table during the experiment The tested area will be marked with a pen to apply every stimulus in the same place
Temporal summation will be evoked in a predetermined area
1 ECRL muscle origin Distal humerus supracondylar ridge
2 ECRB muscle belly identified with resisted radial wrist flexion
3 Brachioradialis 2 cm distal from in the middle of the line extend from lateral epicondyle to middle of the fossa cubiti via identifying resisted elbow flexion in 90 elbow flexion and wrist in neutral position Pressure pain thresholds PPTs will be identified two times with a 30 s interval for each predetermined area via applying circular probe in a perpendicular direction with an increasing pressure at a rate of approximately 1 kgs PPTs will be recorded when the sensation of the mechanical pressure stimulus changes into the first painful sensation The average of two measurements will be used as a PPTs value Temporal summation was induced two minutes after last PPTs was recorded To evoke temporal summation at the lateral elbow the probe will be applied with the pressure of the predefined PPT threshold at the rate of approximately 2 kgs where it will be maintained for 1 s before being released with a 1 s interstimulus interval ISI This procedure will be repeated 10 times in each predetermined area Pain intensity will be asked to participants at first fifth and tenth pulse using a Visual Analog Scale range from 0 indicate no pain to 10 most painful
Placebo Group After flexor and extensor endurance test participants will be provided 20 minutes resting time PPTs value will be evaluted once in each predetermined region with a 30 s interval
Before PPTs assessment in predetermined area on lateral elbow a familirisation session for the perceived PTTs by participants will be performed on palm of the non dominant arm for each group
Sternocleidomastoid Muscle SCM Electrode Placement Electrodes will be placed to the the sternal head of the SCM while participants were sitting in a erect position A line will be drawn from the sternal notch to the mastoid process and marked at 13 of the distance from the sternal notch Electrodes initially will placed adjacent to the this point with 20 mm apart and over the muscle belly based on the muscle palpation during manually resisted neck flexion contractions This location is anticipated to place between the innervation zone and the tendon In supine the head will be placed in a neutral anatomic position that craniocervical and cervical spine is in a mid position It will be ensured visually by examiner that cervical spine is in the neutral position which means from the middle of the subjects forehead to the middle of the chin is horizontal and a line bisecting the neck longitudinally is parallel to the treatment plinth Participants will asked to completely relax in this position For normalization isometric neck flexor contraction will be carried out in supine position via applying manual resistance on frontal region by gradually increasing force that reached maximum force level in 2 second and then contracted maximally for 5 second This procedure will be repeated 3 times with a 30 second time interval
Upper Trapezius UT Muscle Electrode Placement Electrodes will be attached 20 laterally to the midpoint between the dorsal processes of C4 and the posterior lateral third of the clavicle For normalization manual resistance will be given neck extensor while participant lying in prone position Contraction will be lasted 5 second for 3 times with 30 interval
After electrode placement a 5 seconds rest recording will be performed for eliminating basal noise from recording During the endurance test participants will asked not to cough laugh or talk and head position will be controlled by inclinometer adapted to EMG system Participants will be given 3 minutes resting time between neck flexorextensor endurance tests for the experimental group
Neck Flexor Endurance Test An examiner will place her hand under the occiput of the participant while the participant is lying in supine position with the knees bend and the arms resting on the abdomen Cranicervical flexion will be taught to the participants For this participants will asked to place tongue on roof of the mouth with lips together and teeth slightly apart while cervical spine is in neutral position Participants will not be allowed to open mouth during the test Participants will be requested to perform gentle head nodding as if saying yes via sliding head in caudal and cephalic directions on the bed and concentrate feeling of back of the head After learning of the craniocervical flexion the participant will be requested to head off from the examiners hand approximately 25 cm from the plint vhile maintaining the craniocervical flexion and then sustain this position as long as possible The holding time will be recorded with a stopwatch The test will be ended once the participant is unable to hold their head in a correct position that chances occur more than 5 degree for more than one second can no longer maintain craniocervical flexion or head position due to fatigue
Neck Extensor Endurance Test Participants will be asked to lie in a prone position maintaining thoracal extension with a strap at the level of T6 arms in their side and head is end of the plinth The subjects head and neck will be positioned in a comfortable neutral position with the chin retracted 2 kg weight will be placed around the participants head Participants will be asked to sustain this position as long as possible after removing support from the head The test will be ended when the participant can no longer sustain a correct position or when the head position changes more than 5 degrees The holding time will be recorded with a stopwatch
Experimental group
Experimental pain induction Temporal Summation Then participants will be asked to seat in a comfortable position placing their volar faces of the tested dominant arm in elbow flexion on a table during the experiment The tested area will be marked with a pen to apply every stimulus in the same place
Temporal summation will be evoked in a predetermined area
1 ECRL muscle origin Distal humerus supracondylar ridge
2 ECRB muscle belly identified with resisted radial wrist flexion
3 Brachioradialis 2 cm distal from in the middle of the line extend from lateral epicondyle to middle of the fossa cubiti via identifying resisted elbow flexion in 90 elbow flexion and wrist in neutral position Pressure pain thresholds PPTs will be identified two times with a 30 s interval for each predetermined area via applying circular probe in a perpendicular direction with an increasing pressure at a rate of approximately 1 kgs PPTs will be recorded when the sensation of the mechanical pressure stimulus changes into the first painful sensation The average of two measurements will be used as a PPTs value Temporal summation was induced two minutes after last PPTs was recorded To evoke temporal summation at the lateral elbow the probe will be applied with the pressure of the predefined PPT threshold at the rate of approximately 2 kgs where it will be maintained for 1 s before being released with a 1 s interstimulus interval ISI This procedure will be repeated 10 times in each predetermined area Pain intensity will be asked to participants at first fifth and tenth pulse using a Visual Analog Scale range from 0 indicate no pain to 10 most painful
Placebo Group After flexor and extensor endurance test participants will be provided 20 minutes resting time PPTs value will be evaluted once in each predetermined region with a 30 s interval
Before PPTs assessment in predetermined area on lateral elbow a familirisation session for the perceived PTTs by participants will be performed on palm of the non dominant arm for each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None