Clinical trial NCT05022251: Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
Official title: Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lumbar Radiculopathy
Central Sensitisation
Keywords: lumbar radiculopathy
discectomy
central sensitization
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2021-08-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lumbar radiculopathy patients scheduled for first-time, single level, unilateral lumbar discectomy.

Sex, age, and BMI matched healthy controls.

Brief summary: Lumbar discectomy (i.e. surgically removing a hernia) is frequently performed in Belgium to treat lumbar radiculopathy. Every year \>12,000 interventions are performed with variable long-term results. The treatment success of this procedure varies and up to 41% of the patients report post-operative persistent pain complaints, and consequently suffer from failed back surgery syndrome (FBSS). Chronic complaints in FBSS following lumbar discectomy are usually treated with symptomatic interventions (including painkillers, neuromodulation, etc), rather than from a biopsychosocial perspective.

In order to develop a focused and effective treatment strategy, it is crucial to first gain insight into how persons with persistent complaints after lumbar discectomy differ from those without persistent symptoms. Different known contributing factors entail type of surgery, muscle and psychosocial impairments. Although in scientific and clinical literature it is assumed that dysfunctional pain processing also plays an important mechanistic role in FBSS, there is a lack of research to support this. However, this knowledge is crucial to depict the full mechanistic picture of pain generators and potentiators in FBSS.

Therefore, we will examine whether residual complaints persisting following lumbar discectomy can be accounted for by underlying dysfunctional pain processing and whether a clinical classification algorithm can be used to identify the predominant pain mechanism in these patients.


Eligibility criteria: Inclusion Criteria:

* Dutch speaking
* Body mass index below 35kg/m²
* Lumbar radiculopathy patients, classified as ASA I to II without any symptoms of spinal cord compression (i.e. bilateral leg pain), who are scheduled for a first-time, single-level, unilateral lumbar discectomy
* Healthy, pain-free controls (score 0 on a visual analogue scale from 0 to 100)

Exclusion Criteria:

* Female participants will be excluded if pregnant, lactating or \<1 year postnatal
* Having (a history) of severe medical disorders either respiratory (e.g. cystic fibrosis), orthopedic (e.g. whiplash trauma), neurologic (e.g. cerebrovascular incident), cardiovascular (e.g. severe hypertension), endocrinological (e.g. diabetes), psychiatric (e.g. post-traumatic stress disorder
* Having a history of spinal surgery (e.g. discectomy), spinal traumata (e.g. vertebral fracture) or severe spinal deformities (e.g. spondylolisthesis)
* Having a pacemaker or defibrillator
* Healthy controls will be excluded if having suffered low back pain in the preceding year of score 2 or higher on the visual analog scale and which limited their activities of daily living or for which they consulted a (para)medic.

Primary outcomes:
measure: Quantitative sensory testing (QST) - electrical detection threshold
timeFrame: Change from baseline (T1) at 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - electrical pain threshold
timeFrame: Change from baseline (T1) at 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - thermal detection threshold
timeFrame: Change from baseline (T1) at 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - thermal pain threshold
timeFrame: Change from baseline (T1) at 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - discrimination between thermal stimuli
timeFrame: Change from baseline (T1) at 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - tactile detection threshold
timeFrame: Change from baseline (T1) at 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - mechanical pain threshold
timeFrame: Change from baseline (T1) at 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - sensitivity to pressure stimuli
timeFrame: Change from baseline (T1) at 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - temporal summation of electrical stimuli
timeFrame: Change from baseline (T1) and 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - temporal summation of mechanical stimuli
timeFrame: Change from baseline (T1) and 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - spinal hyperexcitability
timeFrame: Change from baseline (T1) and 3 months after surgery (T2)
measure: Quantitative sensory testing (QST) - temporal summation of spinal hyperexcitability
timeFrame: Change from baseline (T1) and 3 months after surgery (T2)
measure: Quantitative sensory testing - conditioned pain modulation
timeFrame: Change from baseline (T1) and 3 months after surgery (T2)
Secondary outcomes:
measure: Central sensitization inventory
timeFrame: Baseline (T1)
measure: Central sensitization inventory
timeFrame: 3 months after surgery (T2)
measure: Douleur Neuropathique 4 Questionnaire
timeFrame: Baseline (T1)
measure: Douleur Neuropathique 4 Questionnaire
timeFrame: 3 months after surgery (T2)
measure: Pain catastrophizing scale
timeFrame: Baseline (T1)
measure: Pain catastrophizing scale
timeFrame: 3 months after surgery (T2)
measure: Pain vigilance and awareness questionnaire
timeFrame: Baseline (T1)
measure: Pain vigilance and awareness questionnaire
timeFrame: 3 months after surgery (T2)
measure: Oswestry disability index
timeFrame: Baseline (T1)
measure: Oswestry disability index
timeFrame: 3 months after surgery (T2)
measure: Tampa scale for kinesiophobia
timeFrame: Baseline (T1)
measure: Tampa scale for kinesiophobia
timeFrame: 3 months after surgery (T2)
measure: International physical activity questionnaire
timeFrame: Baseline (T1)
measure: International physical activity questionnaire
timeFrame: 3 months after surgery (T2)
measure: Patient-reported outcomes measurement information system
timeFrame: Baseline (T1)
measure: Patient-reported outcomes measurement information system
timeFrame: 3 months after surgery (T2)
measure: Brief Illness Perception Questionnaire
timeFrame: Baseline (T1)
measure: Brief Illness Perception Questionnaire
timeFrame: 3 months after surgery (T2)
measure: Pain Coping Inventory
timeFrame: Baseline (T1)
measure: Pain Coping Inventory
timeFrame: 3 months after surgery (T2)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University (Hospital)
Study officials:
affiliation: Ghent University; Research Foundation Flanders
name: Jessica Van Oosterwijck, PhD
role: STUDY_DIRECTOR
References: