Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05022251
Other study ID # BC-08041
Secondary ID 3F014119
Status Terminated
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date October 31, 2023

Study information

Verified date December 2023
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Lumbar discectomy
surgically removing a hernia

Locations

Country Name City State
Belgium Ghent University (Hospital) Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Research Foundation Flanders

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. Change from baseline (T1) at 3 months after surgery (T2)
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. Change from baseline (T1) at 3 months after surgery (T2)
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
Change from baseline (T1) at 3 months after surgery (T2)
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
Change from baseline (T1) at 3 months after surgery (T2)
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. Change from baseline (T1) at 3 months after surgery (T2)
Primary Quantitative sensory testing (QST) - tactile detection threshold Determination of tactile detection threshold, assessed using Von Frey monofilaments, recorded in mN Change from baseline (T1) at 3 months after surgery (T2)
Primary Quantitative sensory testing (QST) - mechanical pain threshold Determination of mechanical pain threshold, assessed using pinprick stimulators, recorded in mN Change from baseline (T1) at 3 months after surgery (T2)
Primary Quantitative sensory testing (QST) - sensitivity to pressure stimuli Determination of pressure pain threshold, assessed using pressure algometry, recorded in kg Change from baseline (T1) at 3 months after surgery (T2)
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.
Change from baseline (T1) and 3 months after surgery (T2)
Primary Quantitative sensory testing (QST) - temporal summation of mechanical stimuli Determination of temporal summation in response to mechanical stimuli delivered using a 256mN pinprick stimulator.
The numerical pain rating in response to these stimuli (range 0 - 100) will be recorded.
Change from baseline (T1) and 3 months after surgery (T2)
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 Change from baseline (T1) and 3 months after surgery (T2)
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) Change from baseline (T1) and 3 months after surgery (T2)
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. Change from baseline (T1) and 3 months after surgery (T2)
Secondary Central sensitization inventory Self-report measure of signs and symptoms associated with central sensitization Baseline (T1)
Secondary Central sensitization inventory Self-report measure of signs and symptoms associated with central sensitization 3 months after surgery (T2)
Secondary Douleur Neuropathique 4 Questionnaire Clinician administered questionnaire for evaluation of signs and symptoms associated with neuropathic pain Baseline (T1)
Secondary Douleur Neuropathique 4 Questionnaire Clinician administered questionnaire for evaluation of signs and symptoms associated with neuropathic pain 3 months after surgery (T2)
Secondary Pain catastrophizing scale Self-report measure of pain perceptions and cognitions Baseline (T1)
Secondary Pain catastrophizing scale Self-report measure of pain perceptions and cognitions 3 months after surgery (T2)
Secondary Pain vigilance and awareness questionnaire Self-report measure assessing preoccupation with and attention to pain Baseline (T1)
Secondary Pain vigilance and awareness questionnaire Self-report measure assessing preoccupation with and attention to pain 3 months after surgery (T2)
Secondary Oswestry disability index Self-report measure evaluating low back pain related disability Baseline (T1)
Secondary Oswestry disability index Self-report measure evaluating low back pain related disability 3 months after surgery (T2)
Secondary Tampa scale for kinesiophobia Self-report measure assessing fear of movement Baseline (T1)
Secondary Tampa scale for kinesiophobia Self-report measure assessing fear of movement 3 months after surgery (T2)
Secondary International physical activity questionnaire Self-report measure of physical activity in preceeding 7 days Baseline (T1)
Secondary International physical activity questionnaire Self-report measure of physical activity in preceeding 7 days 3 months after surgery (T2)
Secondary Patient-reported outcomes measurement information system Self-report measure of health-related domains including:
physical functioning
anxiety
depression
fatigue
sleep disruption
participation in social activities
pain interference
Baseline (T1)
Secondary Patient-reported outcomes measurement information system Self-report measure of health-related domains including:
physical functioning
anxiety
depression
fatigue
sleep disruption
participation in social activities
pain interference
3 months after surgery (T2)
Secondary Brief Illness Perception Questionnaire Self-report measure evaluating illness perceptions Baseline (T1)
Secondary Brief Illness Perception Questionnaire Self-report measure evaluating illness perceptions 3 months after surgery (T2)
Secondary Pain Coping Inventory Self-report measure assessing pain coping strategies Baseline (T1)
Secondary Pain Coping Inventory Self-report measure assessing pain coping strategies 3 months after surgery (T2)
See also
  Status Clinical Trial Phase
Terminated NCT05047679 - The Effectiveness of Pain Neuroscience Education in At-risk Patients Following Surgery for Lumbar Radiculopathy N/A
Withdrawn NCT03543033 - Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes N/A
Recruiting NCT06076408 - Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients N/A
Completed NCT03133845 - Shaping Anesthetic Techniques to Reduce Post-operative Delirium N/A
Completed NCT06087107 - Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa In Patients Of Lumbar Radiculopathy N/A
Completed NCT04852900 - Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy N/A
Recruiting NCT04212949 - The Effect of Transcranial Magnetic Stimulation Therapy in Patients With Lumbar Radiculopathy N/A
Terminated NCT03952377 - Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain Phase 1/Phase 2
Recruiting NCT06339931 - Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy. N/A
Recruiting NCT04540068 - Prediction of TEI Success in Sciatica
Recruiting NCT05953727 - Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients N/A
Recruiting NCT05922228 - Effects of Neural Flossing and PNF on Lumbar Radiculopathy N/A
Completed NCT05449288 - Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study
Completed NCT05874427 - Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form N/A
Terminated NCT01443819 - Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy Phase 3
Recruiting NCT05535010 - The Effect of the Presence of Active Trigger Points in the Muscles Innervated by the Affected Nerve Roots on the Treatment Results of Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy. N/A
Recruiting NCT06154005 - OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion Phase 1/Phase 2
Completed NCT04674917 - Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy N/A
Not yet recruiting NCT06296303 - Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients N/A
Completed NCT04887285 - Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections N/A