The Nociceptive Flexion Reflex as a Diagnostic Tool of Central Sensitization

Low Back Pain Clinical Trial

— NFR-CS  

Official title:

De Nociceptieve Flexie Reflex Als Diagnostische Test Voor Centrale Sensitisatie

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321550
• Other study ID #: BC-5159
• Status: Recruiting
• Start date: April 21, 2022
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: University Ghent
• Contact: Sophie Van Oosterwijck
• Phone: +329 332 69 22
• Email: sophie.vanoosterwijck[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria Fibromyalgia patients:

• diagnosed according to 2010 ACR-criteria

Inclusion Criteria neck pain patients:

• 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

Inclusion Criteria low back pain patients:

• having idiopathic low back pain complaints

Inclusion Criteria healthy controls:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Central Sensitisation
• Fibromyalgia
• Low Back Pain
• Neck Pain
• Whiplash

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline
Primary	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	Baseline
Primary	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	Baseline
Primary	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.	Baseline
Primary	Quantitative sensory testing (QST) - tactile detection threshold	Determination of tactile detection threshold, assessed using Von Frey monofilaments, recorded in mN	Baseline
Primary	Quantitative sensory testing (QST) - mechanical pain threshold	Determination of mechanical pain threshold, assessed using pinprick stimulators, recorded in mN	Baseline
Primary	Quantitative sensory testing (QST) - sensitivity to pressure stimuli	Determination of pressure pain threshold, assessed using pressure algometry, recorded in kg	Baseline
Primary	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.	Baseline
Primary	Quantitative sensory testing (QST) - spinal hyperexcitability	Determination of spinal hyperexcitability using the nociceptive flexion reflex (NFR; sensitization of spinal cord neurons), recorded in mA	Baseline
Primary	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)	Baseline
Primary	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.	Baseline
Secondary	Central sensitization inventory	Self-report measure of signs and symptoms associated with central sensitization	Baseline
Secondary	Douleur Neuropathique 4 Questionnaire	Clinician administered questionnaire for evaluation of signs and symptoms associated with neuropathic pain	Baseline
Secondary	Pain catastrophizing scale	Self-report measure of pain perceptions and cognitions	Baseline
Secondary	Pain vigilance and awareness questionnaire	Self-report measure assessing preoccupation with and attention to pain	Baseline
Secondary	Tampa scale for kinesiophobia	Self-report measure assessing fear of movement	Baseline
Secondary	International physical activity questionnaire	Self-report measure of physical activity in preceeding 7 days	Baseline
Secondary	Patient-reported outcomes measurement information system - physical functioning	Self-report measure of health-related domains relating to physical functioning	Baseline
Secondary	Patient-reported outcomes measurement information system - anxiety	Self-report measure of health-related domains relating to anxiety	Baseline
Secondary	Patient-reported outcomes measurement information system - depression	Self-report measure of health-related domains relating to depression	Baseline
Secondary	Patient-reported outcomes measurement information system - fatigue	Self-report measure of health-related domains relating to fatigue and sleep disruption	Baseline
Secondary	Patient-reported outcomes measurement information system - participation	Self-report measure of health-related domains relating to participation in social activities	Baseline
Secondary	Patient-reported outcomes measurement information system - pain interference	Self-report measure of health-related domains relating to pain interference	Baseline
Secondary	Injustice Experience Questionnaire	Self-report measure of perceived injustice	Baseline
Secondary	Pain Disability Index	Self-report measure of pain-related disability	Baseline