Clinical trial NCT05321550: The Nociceptive Flexion Reflex as a Diagnostic Tool of Central Sensitization
Official title: De Nociceptieve Flexie Reflex Als Diagnostische Test Voor Centrale Sensitisatie
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Sensitisation
Fibromyalgia
Neck Pain
Low Back Pain
Whiplash
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantitative sensory testing (QST) - electrical detection threshold
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - electrical pain threshold
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - thermal detection threshold
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - thermal pain threshold
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - discrimination between thermal stimuli
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - tactile detection threshold
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - mechanical pain threshold
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - sensitivity to pressure stimuli
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - temporal summation of electrical stimuli
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - spinal hyperexcitability
timeFrame: Baseline
measure: Quantitative sensory testing (QST) - temporal summation of spinal hyperexcitability
timeFrame: Baseline
measure: Quantitative sensory testing - conditioned pain modulation
timeFrame: Baseline
Secondary outcomes:
measure: Central sensitization inventory
timeFrame: Baseline
measure: Douleur Neuropathique 4 Questionnaire
timeFrame: Baseline
measure: Pain catastrophizing scale
timeFrame: Baseline
measure: Pain vigilance and awareness questionnaire
timeFrame: Baseline
measure: Tampa scale for kinesiophobia
timeFrame: Baseline
measure: International physical activity questionnaire
timeFrame: Baseline
measure: Patient-reported outcomes measurement information system - physical functioning
timeFrame: Baseline
measure: Patient-reported outcomes measurement information system - anxiety
timeFrame: Baseline
measure: Patient-reported outcomes measurement information system - depression
timeFrame: Baseline
measure: Patient-reported outcomes measurement information system - fatigue
timeFrame: Baseline
measure: Patient-reported outcomes measurement information system - participation
timeFrame: Baseline
measure: Patient-reported outcomes measurement information system - pain interference
timeFrame: Baseline
measure: Injustice Experience Questionnaire
timeFrame: Baseline
measure: Pain Disability Index
timeFrame: Baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Jessica Van Oosterwijck
role: PRINCIPAL_INVESTIGATOR
References: