Low Back Pain Clinical Trial
Official title:
Prognostic Value of Measures of Central Hypersensitivity in Patients With Low Back Pain
Background. Patients with chronic low back pain display hyperexcitability of the central
nervous system (central hypersensitivity). Such hypersensitivity may occur in the acute
phase and represent a risk factor for the development of chronic pain.
Objective. To determine the prognostic value of central hypersensitivity for the development
of chronic low back pain.
Design. Prospective cohort study.
Setting. Primary care.
Patients. 140 individuals with acute low back pain and no history of chronic pain.
Outcomes. Primary prognostic variable will be the pain tolerance threshold at the second toe
(the pressure intensity at which a further increase in pressure is deemed intolerable).
Exploratory secondary prognostic variables are measures of mechanisms related to central
hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold
stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs.
widespread hypersensitivity; spinal cord modulation (electrophysiological measures of
hypersensitivity and changes in receptive fields); modulation at brain level (descending
modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be
the occurrence of chronic low back pain at follow-up.
Main analysis. The investigators will use least square logistic regression models to
determine the association of central hypersensitivity with prognosis.
Relevance. An understanding of the prognostic value of central hypersensitivity may allow an
early stratification for treatment of individuals at risk of developing chronic low back
pain. Subgroups of patients may be selected for clinical trials on novel pharmacological
approaches for the prevention and treatment of central hypersensitivity.
Background
Prolonged afferent nociceptive input induces an increase in the excitability of central
sensory neurons and plasticity changes that cause hyperexcitability of the central nervous
system (central hypersensitivity. The hyperexcitable central nervous system amplifies the
nociceptive signal, thereby producing an exaggerated pain response even in the presence of
limited tissue damage.
Using quantitative sensory tests, central hypersensitivity has been detected in different
chronic musculoskeletal pain syndromes. Patients with chronic low back pain display
increased pain sensitivity and enlargement of the areas of referred pain after stimulation
of tissues around and distant from the site of pain (i.e. the leg or the thumb), suggesting
that widespread central hypersensitivity is associated with this condition. Functional
reorganization of the cortex has been detected in different pain conditions, including low
back pain. Using equal levels of sensory stimulation in patients and pain-free controls,
patients with chronic low back pain showed more extensive patterns of neuronal activation in
pain-related cortical areas.
An investigation on patients after a whiplash injury found that those patients with
persistent moderate or severe symptoms at 6 months had displayed, soon after injury,
widespread hypersensitivity. Therefore, central hypersensitivity may be an indicator of poor
prognosis. An acute peripheral lesion may induce plasticity changes leading to central
hypersensitivity in a subset of individuals. Such a hypersensitivity would facilitate the
transition from acute to chronic pain and disability. This hypothesis has been investigated
using a limited number of tests only in a limited number of individuals with whiplash
injury, but not in any other condition.
Objective
To determine the prognostic value of different measures of mechanisms of central
hypersensitivity in patients with acute low back pain.
Methods
140 consecutive Patients with acute low back pain, referred by general practice, will be
studied prospectively. Primary prognostic variable will be the pain tolerance threshold at
the second toe (the pressure intensity at which a further increase in pressure is deemed
intolerable). Exploratory secondary prognostic variables are measures of mechanisms related
to central hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat
and cold stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation);
localized vs. widespread hypersensitivity; spinal cord modulation (electrophysiological
measures of hypersensitivity and changes in receptive fields); modulation at brain level
(descending modulation of nociceptive input and cortical plasticity). Clinical primary
outcome will be the occurrence of chronic low back pain at follow-up. The investigators will
use least square logistic regression models to determine the association of central
hypersensitivity with prognosis.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03916705 -
Thoraco-Lumbar Fascia Mobility
|
N/A | |
| Completed |
NCT04007302 -
Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago
|
N/A | |
| Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
| Recruiting |
NCT03600207 -
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
|
N/A | |
| Completed |
NCT04284982 -
Periodized Resistance Training for Persistent Non-specific Low Back Pain
|
N/A | |
| Recruiting |
NCT05600543 -
Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain
|
N/A | |
| Withdrawn |
NCT05410366 -
Safe Harbors in Emergency Medicine, Specific Aim 3
|
||
| Completed |
NCT03673436 -
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
|
||
| Completed |
NCT02546466 -
Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain
|
N/A | |
| Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
| Recruiting |
NCT05156242 -
Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain.
|
N/A | |
| Recruiting |
NCT04673773 -
MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.
|
N/A | |
| Completed |
NCT06049277 -
Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain
|
N/A | |
| Completed |
NCT06049251 -
ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises
|
N/A | |
| Completed |
NCT04980469 -
A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
|
N/A | |
| Completed |
NCT04055545 -
High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects
|
N/A | |
| Recruiting |
NCT05552248 -
Assessment of the Safety and Performance of a Lumbar Belt
|
||
| Recruiting |
NCT05944354 -
Wearable Spine Health System for Military Readiness
|
||
| Completed |
NCT05801588 -
Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life
|
N/A | |
| Completed |
NCT05811143 -
Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.
|