Unraveling Back Pain Chronicity: an EMG and EEG Study

NCT03705676 | Completed

• 1 other identifier: 2016/0186
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at examining the influence of both threat of experimentally induced pain and clinical low back pain (LBP) on trunk motor control on the one hand and brain activity related to movement preparation on the other hand. Therefore, 3 groups are studied: healthy controls, people with recurrent LBP, and people with chronic LBP. A comparison in electromyography (EMG) of the trunk muscles and electroencephalography (EEG) activity between the 3 groups will be made in 2 conditions: a control condition without experimental pain on 1 test day, and a fear condition with experimental pain on another test day. In both conditions a motor control task will be performed and muscle and brain activity will be measured during each motor control task. It is hypothesised that motor control will be different between the 3 groups in both conditions, i.e. delayed trunk muscle onset in LBP groups compared with controls. With regards to the brain activity, it is expected that preparation for movement will also be delayed in the LBP groups. Furthermore, it is expected that the fear condition will entail differences in both EMG and EEG within each group.

Conditions

Low Back Pain

Keywords

Sensorimotor control; Event-related potentials; Cortical movement preparation

Outcome Measures

Primary Outcomes (3)

• Trunk muscle EMG latency

  Latency of the activation onset of the trunk muscles on EMG compared to prime mover onset (Anterior Deltoid) in milliseconds.

  2 hours

• Contingent Negative Variation

  A cortical EEG-potential that reflects movement preparation in the timeframe between a warning cue and a go cue in Volt.

  2 hours

• Somatosensory Evoked Potentials

  Cortical EEG-potentials that reflect the awareness and processing of somatosensory information, in this case vibrotactile stimuli on the lower back in Herz.

  2 hours

Secondary Outcomes (11)

• Visual Analogue Scale for Pain

  Before, midway and after each RAM block, with a duration of 10 seconds. This in both test day 1 and 2, which are minimally separated by 5 days between test days.

• Rating of Perceived Exertion/Borg

  After each RAM block, with a duration of 5 seconds. This in both test day 1 and 2, which are minimally separated by 5 days between test days.

• International Physical Activities Questionnaire

  15 minutes at the beginning of each of two test days, which are minimally separated by 5 days between test days.

• General Questionnaire

  10 minutes at the beginning of test day 1

• General Questionnaire - Short

  10 minutes at the beginning of test day 2

Study Arms (6)

Healthy controls - control condition

ACTIVE COMPARATOR

Assesses EMG and EEG activity of healthy controls during a rapid arm task after a warning and go cue. No painful stimuli are administered, only non-painful vibrotactile stimuli.

Behavioral: Rapid Arm Movements; Device: Vibrotactile stimulus

Healthy controls - fear condition

EXPERIMENTAL

Assesses EMG and EEG activity of healthy controls during a rapid arm task after a warning and go cue. Half of the trials are no threat trials, the other half are threat trials. A painful stimulus is administered during arm movement in 25% of the threat trials in order to evoke anticipation of pain during the 75% other threat trials.

Behavioral: Rapid Arm Movements; Device: Unpleasant stimulus; Device: Vibrotactile stimulus

RLBP - control condition

ACTIVE COMPARATOR

Assesses EMG and EEG activity of RLBP subjects during a rapid arm task after a warning and go cue. No painful stimuli are administered, only non-painful vibrotactile stimuli.

Behavioral: Rapid Arm Movements; Device: Vibrotactile stimulus

RLBP - fear condition

EXPERIMENTAL

Assesses EMG and EEG activity of RLBP subjects during a rapid arm task after a warning and go cue. Half of the trials are no threat trials, the other half are threat trials. A painful stimulus is administered during arm movement in 25% of the threat trials in order to evoke anticipation of pain during the 75% other threat trials.

Behavioral: Rapid Arm Movements; Device: Unpleasant stimulus; Device: Vibrotactile stimulus

CLBP - control condition

ACTIVE COMPARATOR

Assesses EMG and EEG activity of CLBP subjects during a rapid arm task after a warning and go cue. No painful stimuli are administered, only non-painful vibrotactile stimuli.

Behavioral: Rapid Arm Movements; Device: Vibrotactile stimulus

CLBP - fear condition

EXPERIMENTAL

Assesses EMG and EEG activity of CLBP subjects during a rapid arm task after a warning and go cue. Half of the trials are no threat trials, the other half are threat trials. A painful stimulus is administered during arm movement in 25% of the threat trials in order to evoke anticipation of pain during the 75% other threat trials.

Behavioral: Rapid Arm Movements; Device: Unpleasant stimulus; Device: Vibrotactile stimulus

Interventions

Rapid Arm Movements BEHAVIORAL

240 trials of RAM in either a forward (50%) or backward (50%) shoulder flexion direction and back to neutral as fast as possible, with maintaining extension in the elbow. Visual cues (arrows) indicated the movement direction.

CLBP - control condition; CLBP - fear condition; Healthy controls - control condition; Healthy controls - fear condition; RLBP - control condition; RLBP - fear condition

Unpleasant stimulus DEVICE

An unpleasant, but harmless, electrocutaneous stimulus is administered to the low back region in 25% of the threat trials during the fear condition. Due to a conditioning phase before testing, participants know to expect this stimulus after the presentation of a warning cue related to the fear trials (either pink or blue dot dependent on randomization).

Also known as: Electrocutaneous stimulus

CLBP - fear condition; Healthy controls - fear condition; RLBP - fear condition

Vibrotactile stimulus DEVICE

In all trials, during the presentation of the warning cue, a vibrotactile stimulus is administered to the low back region. This stimulus is used to evoke somatosensory evoked potentials (SEP) measured with EEG during the movement-preparation phase.

CLBP - control condition; CLBP - fear condition; Healthy controls - control condition; Healthy controls - fear condition; RLBP - control condition; RLBP - fear condition

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult subjects.

You may not qualify if:

• People with a history of pain or current pain
• severe pathologies
• traumata
• cardiorespiratory disorders
• neurological disorders
• vestibular disorders
• endocrinologic disorders
• psychiatric and cognitive disorders
• colour blindness
• sleeping disorders
• psychological disorders or major depressions
• major surgery to the spine or upper limbs
• clinically relevant malalignments and deformities
• malignancies
• substance abuse of alcohol or drugs

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Vakgroep REVAKI (Ghent University - Ghent University Hospital)

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lieven Danneels, PT, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants are aware that electrocutaneous stimulation might occur during the fear condition and never during the control condition. This is of paramount importance, as the expectancy of a painful stimulus is the main difference between both conditions. The researcher that will perform the EMG-analysis, i.e. onset determination of the various muscles that were measured, will be blinded for participant, condition and muscle during that process. EEG-data does not have to be blinded as data processing is computer based and not subjectable to subjective bias of a researcher.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will perform both experimental conditions spread out over 2 test days in a randomized order. Between 2 test days a minimum of 5 days has to be present in order to ensure full recuperation from test day 1. Half of the participants will receive the control condition on test day 1 and the fear condition on day 2, the other half vice versa.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: October 15, 2018
• Study Start: March 3, 2017
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)