Central SensitisationNFR-CSNCT05321550
The Nociceptive Flexion Reflex as a Diagnostic Tool of Central Sensitization
An observational study of Central Sensitisation and Fibromyalgia, run by University Ghent at 1 site in Belgium.
Trial summary
This experimental study will investigate whether the decreased NFR threshold and increased NFR temporal summation, which are frequently observed in chronic pain patients, are only symptomatic manifestations that occur in the involved limb and indicate peripheral sensitization or generalized manifestations that are… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Sensitisation, Fibromyalgia, Neck Pain
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Apr 2022to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Fibromyalgia patients (n=30) diagnosed according to the 2010 ACR-criteria * Patients with non-specific, idiopathic neck pain complaints which are acute (n=30) or chronic (n=30) * Patients with neck pain complaints of traumatic origin type whiplash grade 1 (pain, stiffness or tenderness of the neck and no objective physical abnormalities) and grade 2 (neck complaints and musculoskeletal disorders such as reduced range of motion and tender pain points) according to the Quebec Task Force on Whiplash Associated Disorders which is acute (n=30) or chronic (n=30) * Patients with non-specific, idiopathic back pain complaints which are acute (n=30) or chronic (n=30) * Healthy controls (n=30) matched based on age, sex and BMI
Who may be able to join
- diagnosed according to 2010 ACR-criteria
- having idiopathic neck pain complaints or having grade 1 (pain, stiffness or tenderness of the neck and without objective physical abnormalities) or grade 2 (neck complaints and musculoskeletal disorders such as decreased range of motion and tender pain points) according to the Quebec Task Force on Whiplash Associated Disorders
- having idiopathic low back pain complaints
- no history of serious pain complaints (e.g. severe migraine, fibromyalgia, etc.)
- no low back or neck pain complaints with an intensity of ≥2/10 on a visual analogue scale in the past year and of such severity that the daily activities were disrupted and a (para)medic was consulted
Who cannot join
- history of severe respiratory (e.g. cystic fibrosis), orthopedic (e.g. whiplash trauma), neurological (e.g. cerebrovascular incident), cardiovascular (e.g. severe hypertension), or endocrinological (e.g. diabetes) disorders
- recent psychological trauma (e.g. post-traumatic stress disorder)
- history of spinal surgery (e.g. lumbar discectomy), spinal trauma (e.g. vertebral fracture), or severe spinal deformities (e.g. spondylolisthesis)
- BMI ≥35 (due to potential difficulties in obtaining an NFR in severely overweight individuals)
- having pacemakers and defibrillators (absolute exclusion criteria for electrical stimulus stimulation, i.e. TENS)
- pregnancy, lactation, or within 1 year postpartum
Trial locations and contacts
1 site in 1 country.
Jessica Van Oosterwijck contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent
Sophie Van Oosterwijck, sophie.vanoosterwijck@ugent.be
Sophie Van Oosterwijck
About this study
Official title: De Nociceptieve Flexie Reflex Als Diagnostische Test Voor Centrale Sensitisatie
This experimental study will investigate whether the decreased NFR threshold and increased NFR temporal summation, which are frequently observed in chronic pain patients, are only symptomatic manifestations that occur in the involved limb and indicate peripheral sensitization or generalized manifestations that are also present in the non-involved limbs and thus indicate central sensitization. To gain an idea of the presence of central sensitization, this study will also investigate whether there are increased perception and decreased pain thresholds in response to electrical, thermal, and mechanical stimulation, as well as whether there is a decreased conditioned pain modulation. To investigate this, it is essential to examine different pain populations and locations, in particular, acute pain versus chronic pain populations to compare peripheral versus central sensitization, respectively. Recently, our research group has shown that patients with a traumatic origin of chronic neck pain (chronic whiplash-associated disorders) show central sensitization in contrast to patients with a non-traumatic origin (chronic idiopathic neck pain) who demonstrate only indications for peripheral sensitization. Therefore, this study will also distinguish between complaints of traumatic and non-traumatic origin.
The measurements will be performed at different locations, namely the lower and upper limbs. To determine whether the differences depend on the measurement location (= location where experimental nociceptive stimulation is administered) and symptom location (= location of clinical nociceptive stimulation), different patient populations will be compared with each other, as well as with a healthy control population. In acute and chronic whiplash patients and patients with acute and chronic idiopathic neck pain complaints, the complaints are primarily localized in the upper limb. It is hypothesized that in chronic neck pain patients (both whiplash and idiopathic neck pain patients) abnormal values are found in both the upper and lower limbs compared to the healthy controls due to central sensitization. In acute neck pain patients (both whiplash and idiopathic neck pain) only abnormal values in the arm are expected and not in the leg as a result of peripheral sensitization. It is hypothesized that patients with neck pain of traumatic origin will show a stronger sensitization than those with neck pain of non-traumatic origin. In acute and chronic low back pain patients, the complaints are primarily localized in the lower body quadrant. As a result of central sensitization in the chronic low back pain patients, abnormal values are expected in both the upper and lower limbs, while only abnormal values in the leg are expected as a result of peripheral sensitization in the acute low back pain patients. Finally, this study will investigate whether chronic low back and neck pain patients show a similar pattern of central sensitization as fibromyalgia patients, a population with generalized complaints that are primarily attributed to central sensitization.
- Conditions
- Central Sensitisation, Fibromyalgia, Neck Pain, Low Back Pain, Whiplash
- Medical subject headings
- Fibromyalgia, Neck Pain, Low Back Pain, Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia patients | Fibromyalgia patients diagnosed according to the 2010 ACR-criteria | |
| Neck pain patients | * Patients with non-specific, idiopathic neck pain complaints * Patients with neck pain complaints of traumatic origin type whiplash grade 1 (pain, stiffness or tenderness of the neck and no objective physical abnormalities) and grade 2 (neck complaints and musculoskeletal disorders such as reduced range of motion and tender pain points) according to the Quebec Task Force on Whiplash Associated Disorders | |
| Low back pain patients | Patients with non-specific, idiopathic back pain complaints | |
| Healthy controls | Age, sex and BMI-matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative sensory testing (QST) - electrical detection threshold
Determination of sensory detection thresholds in response to electrical stimuli which are delivered transcutaneously over the n. suralis and n. medianus, recorded in mA.
Measured: Baseline
Quantitative sensory testing (QST) - electrical pain threshold
Determination of sensory pain threshold in response to electrical stimuli which are delivered transcutaneously over the n. suralis and n. medianus, recorded in mA.
Measured: Baseline
Quantitative sensory testing (QST) - thermal detection threshold
Determination of sensory detection thresholds in response to thermal stimuli which are delivered to the skin using a thermode, recorded in °C:
- cold detection threshold
- warmth detection threshold
Measured: Baseline
Quantitative sensory testing (QST) - thermal pain threshold
Determination of sensory pain thresholds in response to thermal stimuli which are delivered to the skin using a thermode, recorded in °C:
- cold pain threshold
- heat pain threshold
Measured: Baseline
Quantitative sensory testing (QST) - discrimination between thermal stimuli
Determination of the number of paradoxical heat sensations in response to alternating cold and warm stimuli delivered to the skin using a thermode.
Measured: Baseline
Quantitative sensory testing (QST) - tactile detection threshold
Determination of tactile detection threshold, assessed using Von Frey monofilaments, recorded in mN
Measured: Baseline
Quantitative sensory testing (QST) - mechanical pain threshold
Determination of mechanical pain threshold, assessed using pinprick stimulators, recorded in mN
Measured: Baseline
Quantitative sensory testing (QST) - sensitivity to pressure stimuli
Determination of pressure pain threshold, assessed using pressure algometry, recorded in kg
Measured: Baseline
Quantitative sensory testing (QST) - temporal summation of electrical stimuli
Determination of temporal summation in response to electrical stimuli delivered transcutaneously over the skin of the n. suralis and n. medianus.
The numerical pain rating in response to these stimuli (range 0 - 100) will be recorded.
Measured: Baseline
Quantitative sensory testing (QST) - spinal hyperexcitability
Determination of spinal hyperexcitability using the nociceptive flexion reflex (NFR; sensitization of spinal cord neurons), recorded in mA
Measured: Baseline
Quantitative sensory testing (QST) - temporal summation of spinal hyperexcitability
Determination of temporal summation of the nociceptive flexion reflex (NFR; sensitization of spinal cord neurons), recorded using a numeric pain rating scale (range 0 - 100)
Measured: Baseline
Quantitative sensory testing - conditioned pain modulation
Determination of condition pain modulation (aka. pain inhibits pain) by means of a heterotopic noxious counterstimulation paradigm. Test stimuli comprise of pressure pain threshold assessments and application of a heat stimulus (using a thermode) corresponding to a temperature eliciting a visual analog scale rating of 5/10. Test stimuli will be applied before, during and after the conditioning stimulus which is the immersion of the hand in a hot circulating water bath of 45.5°C.
Measured: Baseline
Secondary outcomes (14)
Central sensitization inventory
Self-report measure of signs and symptoms associated with central sensitization
Measured: Baseline
Douleur Neuropathique 4 Questionnaire
Clinician administered questionnaire for evaluation of signs and symptoms associated with neuropathic pain
Measured: Baseline
Pain catastrophizing scale
Self-report measure of pain perceptions and cognitions
Measured: Baseline
Pain vigilance and awareness questionnaire
Self-report measure assessing preoccupation with and attention to pain
Measured: Baseline
Tampa scale for kinesiophobia
Self-report measure assessing fear of movement
Measured: Baseline
International physical activity questionnaire
Self-report measure of physical activity in preceeding 7 days
Measured: Baseline
Patient-reported outcomes measurement information system - physical functioning
Self-report measure of health-related domains relating to physical functioning
Measured: Baseline
Patient-reported outcomes measurement information system - anxiety
Self-report measure of health-related domains relating to anxiety
Measured: Baseline
Patient-reported outcomes measurement information system - depression
Self-report measure of health-related domains relating to depression
Measured: Baseline
Patient-reported outcomes measurement information system - fatigue
Self-report measure of health-related domains relating to fatigue and sleep disruption
Measured: Baseline
Patient-reported outcomes measurement information system - participation
Self-report measure of health-related domains relating to participation in social activities
Measured: Baseline
Patient-reported outcomes measurement information system - pain interference
Self-report measure of health-related domains relating to pain interference
Measured: Baseline
Injustice Experience Questionnaire
Self-report measure of perceived injustice
Measured: Baseline
Pain Disability Index
Self-report measure of pain-related disability
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start21 Apr 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitisationStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Van Oosterwijck, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321550
- Sponsor's protocol ID
- BC-5159
- Acronym
- NFR-CS
- Status last verified
- Jan 2024
- First submitted
- 22 Mar 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De Nociceptieve Flexie Reflex Als Diagnostische Test Voor Centrale Sensitisatie
- ClinicalTrials.gov ID
- NCT05321550
- Acronym / sponsor ID
- NFR-CS / BC-5159
- Conditions
- Central Sensitisation, Fibromyalgia, Neck Pain, Low Back Pain, Whiplash
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This experimental study will investigate whether the decreased NFR threshold and increased NFR temporal summation, which are frequently observed in chronic pain patients, are only symptomatic manifestations that occur in the involved limb and indicate peripheral sensitization or generalized manifestations that are also present in the non-involved limbs and thus indicate central sensitization. To gain an idea of the presence of central sensitization, this study will also investigate whether there are increased perception and decreased pain thresholds in response to electrical, thermal, and mechanical stimulation, as well as whether there is a decreased conditioned pain modulation. To investigate this, it is essential to examine different pain populations and locations, in particular, acute pain versus chronic pain populations to compare peripheral versus central sensitization, respectively. Recently, our research group has shown that patients with a traumatic origin of chronic neck pain (chronic whiplash-associated disorders) show central sensitization in contrast to patients with a non-traumatic origin (chronic idiopathic neck pain) who demonstrate only indications for peripheral sensitization. Therefore, this study will also distinguish between complaints of traumatic and non-traumatic origin.
The measurements will be performed at different locations, namely the lower and upper limbs. To determine whether the differences depend on the measurement location (= location where experimental nociceptive stimulation is administered) and symptom location (= location of clinical nociceptive stimulation), different patient populations will be compared with each other, as well as with a healthy control population. In acute and chronic whiplash patients and patients with acute and chronic idiopathic neck pain complaints, the complaints are primarily localized in the upper limb. It is hypothesized that in chronic neck pain patients (both whiplash and idiopathic neck pain patients) abnormal values are found in both the upper and lower limbs compared to the healthy controls due to central sensitization. In acute neck pain patients (both whiplash and idiopathic neck pain) only abnormal values in the arm are expected and not in the leg as a result of peripheral sensitization. It is hypothesized that patients with neck pain of traumatic origin will show a stronger sensitization than those with neck pain of non-traumatic origin. In acute and chronic low back pain patients, the complaints are primarily localized in the lower body quadrant. As a result of central sensitization in the chronic low back pain patients, abnormal values are expected in both the upper and lower limbs, while only abnormal values in the leg are expected as a result of peripheral sensitization in the acute low back pain patients. Finally, this study will investigate whether chronic low back and neck pain patients show a similar pattern of central sensitization as fibromyalgia patients, a population with generalized complaints that are primarily attributed to central sensitization.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia patients | – | –Fibromyalgia patients diagnosed according to the 2010 ACR-criteria |
| Neck pain patients | – | –* Patients with non-specific, idiopathic neck pain complaints * Patients with neck pain complaints of traumatic origin type whiplash grade 1 (pain, stiffness or tenderness of the neck and no objective physical abnormalities) and grade 2 (neck complaints and musculoskeletal disorders such as reduced range of motion and tender pain points) according to the Quebec Task Force on Whiplash Associated Disorders |
| Low back pain patients | – | –Patients with non-specific, idiopathic back pain complaints |
| Healthy controls | – | –Age, sex and BMI-matched healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Fibromyalgia patients (n=30) diagnosed according to the 2010 ACR-criteria * Patients with non-specific, idiopathic neck pain complaints which are acute (n=30) or chronic (n=30) * Patients with neck pain complaints of traumatic origin type whiplash grade 1 (pain, stiffness or tenderness of the neck and no objective physical abnormalities) and grade 2 (neck complaints and musculoskeletal disorders such as reduced range of motion and tender pain points) according to the Quebec Task Force on Whiplash Associated Disorders which is acute (n=30) or chronic (n=30) * Patients with non-specific, idiopathic back pain complaints which are acute (n=30) or chronic (n=30) * Healthy controls (n=30) matched based on age, sex and BMI
Key inclusion criteria (5 listed)
- diagnosed according to 2010 ACR-criteria
- having idiopathic neck pain complaints or having grade 1 (pain, stiffness or tenderness of the neck and without objective physical abnormalities) or grade 2 (neck complaints and musculoskeletal disorders such as decreased range of motion and tender pain points) according to the Quebec Task Force on Whiplash Associated Disorders
- having idiopathic low back pain complaints
- no history of serious pain complaints (e.g. severe migraine, fibromyalgia, etc.)
- no low back or neck pain complaints with an intensity of ≥2/10 on a visual analogue scale in the past year and of such severity that the daily activities were disrupted and a (para)medic was consulted
Key exclusion criteria (6 listed)
- history of severe respiratory (e.g. cystic fibrosis), orthopedic (e.g. whiplash trauma), neurological (e.g. cerebrovascular incident), cardiovascular (e.g. severe hypertension), or endocrinological (e.g. diabetes) disorders
- recent psychological trauma (e.g. post-traumatic stress disorder)
- history of spinal surgery (e.g. lumbar discectomy), spinal trauma (e.g. vertebral fracture), or severe spinal deformities (e.g. spondylolisthesis)
- BMI ≥35 (due to potential difficulties in obtaining an NFR in severely overweight individuals)
- having pacemakers and defibrillators (absolute exclusion criteria for electrical stimulus stimulation, i.e. TENS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative sensory testing (QST) - electrical detection threshold
Time frame: Baseline
Determination of sensory detection thresholds in response to electrical stimuli which are delivered transcutaneously over the n. suralis and n. medianus, recorded in mA.
Quantitative sensory testing (QST) - electrical pain threshold
Time frame: Baseline
Determination of sensory pain threshold in response to electrical stimuli which are delivered transcutaneously over the n. suralis and n. medianus, recorded in mA.
Quantitative sensory testing (QST) - thermal detection threshold
Time frame: Baseline
Determination of sensory detection thresholds in response to thermal stimuli which are delivered to the skin using a thermode, recorded in °C: * cold detection threshold * warmth detection threshold
Quantitative sensory testing (QST) - thermal pain threshold
Time frame: Baseline
Determination of sensory pain thresholds in response to thermal stimuli which are delivered to the skin using a thermode, recorded in °C: * cold pain threshold * heat pain threshold
Quantitative sensory testing (QST) - discrimination between thermal stimuli
Time frame: Baseline
Determination of the number of paradoxical heat sensations in response to alternating cold and warm stimuli delivered to the skin using a thermode.
Quantitative sensory testing (QST) - tactile detection threshold
Time frame: Baseline
Determination of tactile detection threshold, assessed using Von Frey monofilaments, recorded in mN
Quantitative sensory testing (QST) - mechanical pain threshold
Time frame: Baseline
Determination of mechanical pain threshold, assessed using pinprick stimulators, recorded in mN
Quantitative sensory testing (QST) - sensitivity to pressure stimuli
Time frame: Baseline
Determination of pressure pain threshold, assessed using pressure algometry, recorded in kg
Quantitative sensory testing (QST) - temporal summation of electrical stimuli
Time frame: Baseline
Determination of temporal summation in response to electrical stimuli delivered transcutaneously over the skin of the n. suralis and n. medianus. The numerical pain rating in response to these stimuli (range 0 - 100) will be recorded.
Quantitative sensory testing (QST) - spinal hyperexcitability
Time frame: Baseline
Determination of spinal hyperexcitability using the nociceptive flexion reflex (NFR; sensitization of spinal cord neurons), recorded in mA
Quantitative sensory testing (QST) - temporal summation of spinal hyperexcitability
Time frame: Baseline
Determination of temporal summation of the nociceptive flexion reflex (NFR; sensitization of spinal cord neurons), recorded using a numeric pain rating scale (range 0 - 100)
Quantitative sensory testing - conditioned pain modulation
Time frame: Baseline
Determination of condition pain modulation (aka. pain inhibits pain) by means of a heterotopic noxious counterstimulation paradigm. Test stimuli comprise of pressure pain threshold assessments and application of a heat stimulus (using a thermode) corresponding to a temperature eliciting a visual analog scale rating of 5/10. Test stimuli will be applied before, during and after the conditioning stimulus which is the immersion of the hand in a hot circulating water bath of 45.5°C.
14 secondary outcomes
Central sensitization inventory
Time frame: Baseline
Douleur Neuropathique 4 Questionnaire
Time frame: Baseline
Pain catastrophizing scale
Time frame: Baseline
Pain vigilance and awareness questionnaire
Time frame: Baseline
Tampa scale for kinesiophobia
Time frame: Baseline
International physical activity questionnaire
Time frame: Baseline
Patient-reported outcomes measurement information system - physical functioning
Time frame: Baseline
Patient-reported outcomes measurement information system - anxiety
Time frame: Baseline
Patient-reported outcomes measurement information system - depression
Time frame: Baseline
Patient-reported outcomes measurement information system - fatigue
Time frame: Baseline
Patient-reported outcomes measurement information system - participation
Time frame: Baseline
Patient-reported outcomes measurement information system - pain interference
Time frame: Baseline
Injustice Experience Questionnaire
Time frame: Baseline
Pain Disability Index
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Van Oosterwijck contact
Jessica Van Oosterwijck principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sensitisation and Fibromyalgia, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Van Oosterwijck (+329 332 69 22, sophie.vanoosterwijck@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative sensory testing (QST) - electrical detection threshold (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.