Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy

Lumbar Radiculopathy Clinical Trial

— DISC-PAIN  

Official title:

Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05022251
• Other study ID #: BC-08041
• Secondary ID: 3F014119
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Central Sensitisation
• Lumbar Radiculopathy
• Radiculopathy

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)