NCT05146960

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

November 9, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

October 29, 2021

Last Update Submit

December 8, 2023

Conditions

Keywords

motor performancepaintemporal summation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Sternocleidomastoid muscle normalized median frequency of the slope at 20 minutes

    It shows fatigue characteristic of the muscle

    Baseline and minutes 20

Secondary Outcomes (3)

  • Change from baseline upper trapezius muscle normalized median frequency of the slope at 20 minutes

    Baseline and minutes 20

  • Changes from baseline mean amplitude of the sternocleidomastoid muscle at 20 minutes

    Baseline and minutes 20

  • Changes from baseline mean amplitude of the upper trapezius muscle at 20 minutes

    Baseline and minutes 20

Study Arms (2)

Temporal summation

EXPERIMENTAL

Temporal summation will be evoked in ECRL muscle origin, ECRB muscle belly, Brachioradialis. Pressure pain thresholds (PPTs) will be identified two times with a 30 s interval for each predetermined area. 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 kg/s 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

Other: Temporal summation

Placebo

PLACEBO COMPARATOR

pressure pain threshold will be evaluated once in each predetermined region with a 30 second interval.

Other: Placebo

Interventions

Temporal summation will be evoked in each predetermined area

Temporal summation
PlaceboOTHER

PPTs will be assessed once in each predetermined area

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be healthy

You may not qualify if:

  • have suffered pain at an intensity of more than 2/10 for more than 8 days in the preceding year;
  • having had a pain condition in the last 6 months for which treatment was sought;
  • have undergone surgery in the neck or elbow region in the preceding year;
  • suffer major depression or psychiatric illness (diagnosed by a psychiatrist and being in medical or psychiatric treatment);
  • be diagnosed with life threatening, metabolic, cardiovascular, neurologic, systemic diseases;
  • be pregnant or have given birth in the preceding year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

  • Canli K, Palmans T, Meeus M, De Meulemeester K. Excitation of the bottom-up pathways has no effect on remote muscle fatigue in healthy participants. Exp Brain Res. 2024 Nov 27;243(1):2. doi: 10.1007/s00221-024-06958-w.

MeSH Terms

Conditions

FatiguePain

Interventions

Postsynaptic Potential Summation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Synaptic TransmissionSignal TransductionBiochemical PhenomenaChemical PhenomenaSynaptic PotentialsMembrane PotentialsCell Physiological PhenomenaElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

December 7, 2021

Study Start

November 9, 2021

Primary Completion

December 20, 2021

Study Completion

January 1, 2022

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations