Lumbar RadiculopathyDISC-PAINNCT05022251
Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
An observational study of Lumbar Radiculopathy and Central Sensitisation, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Radiculopathy, Central Sensitisation
- What is being tested?
- Lumbar discectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lumbar radiculopathy patients scheduled for first-time, single level, unilateral lumbar discectomy. Sex, age, and BMI matched healthy controls.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lumbar Radiculopathy, Central Sensitisation
- Being tested
- Lumbar discectomy
- Keywords
- lumbar radiculopathy, discectomy, central sensitization
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar discectomyProcedure or surgery
surgically removing a hernia
| Study group | Role | What they receive |
|---|---|---|
| Lumbar radiculopathy | Lumbar radiculopathy patients (n=122), 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. Receives: Procedure: Lumbar discectomy | |
| Healthy controls | Sex, age, and BMI-matched healthy, pain-free control subjects (n=122) will be recruited for study participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (T1) at 3 months after surgery (T2)
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.
Measured: Change from baseline (T1) at 3 months after surgery (T2)
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
Measured: Change from baseline (T1) at 3 months after surgery (T2)
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
Measured: Change from baseline (T1) at 3 months after surgery (T2)
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.
Measured: Change from baseline (T1) at 3 months after surgery (T2)
Quantitative sensory testing (QST) - tactile detection threshold
Determination of tactile detection threshold, assessed using Von Frey monofilaments, recorded in mN
Measured: Change from baseline (T1) at 3 months after surgery (T2)
Quantitative sensory testing (QST) - mechanical pain threshold
Determination of mechanical pain threshold, assessed using pinprick stimulators, recorded in mN
Measured: Change from baseline (T1) at 3 months after surgery (T2)
Quantitative sensory testing (QST) - sensitivity to pressure stimuli
Determination of pressure pain threshold, assessed using pressure algometry, recorded in kg
Measured: Change from baseline (T1) at 3 months after surgery (T2)
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.
Measured: Change from baseline (T1) and 3 months after surgery (T2)
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.
Measured: Change from baseline (T1) and 3 months after surgery (T2)
Quantitative sensory testing (QST) - spinal hyperexcitability
Determination of spinal hyperexcitability using the nociceptive flexion reflex (NFR; sensitization of spinal cord neurons), recorded in mA
Measured: Change from baseline (T1) and 3 months after surgery (T2)
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)
Measured: Change from baseline (T1) and 3 months after surgery (T2)
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.
Measured: Change from baseline (T1) and 3 months after surgery (T2)
Secondary outcomes (20)
Central sensitization inventory
Self-report measure of signs and symptoms associated with central sensitization
Measured: Baseline (T1)
Central sensitization inventory
Self-report measure of signs and symptoms associated with central sensitization
Measured: 3 months after surgery (T2)
Douleur Neuropathique 4 Questionnaire
Clinician administered questionnaire for evaluation of signs and symptoms associated with neuropathic pain
Measured: Baseline (T1)
Douleur Neuropathique 4 Questionnaire
Clinician administered questionnaire for evaluation of signs and symptoms associated with neuropathic pain
Measured: 3 months after surgery (T2)
Pain catastrophizing scale
Self-report measure of pain perceptions and cognitions
Measured: Baseline (T1)
Pain catastrophizing scale
Self-report measure of pain perceptions and cognitions
Measured: 3 months after surgery (T2)
Pain vigilance and awareness questionnaire
Self-report measure assessing preoccupation with and attention to pain
Measured: Baseline (T1)
Pain vigilance and awareness questionnaire
Self-report measure assessing preoccupation with and attention to pain
Measured: 3 months after surgery (T2)
Oswestry disability index
Self-report measure evaluating low back pain related disability
Measured: Baseline (T1)
Oswestry disability index
Self-report measure evaluating low back pain related disability
Measured: 3 months after surgery (T2)
Tampa scale for kinesiophobia
Self-report measure assessing fear of movement
Measured: Baseline (T1)
Tampa scale for kinesiophobia
Self-report measure assessing fear of movement
Measured: 3 months after surgery (T2)
International physical activity questionnaire
Self-report measure of physical activity in preceeding 7 days
Measured: Baseline (T1)
International physical activity questionnaire
Self-report measure of physical activity in preceeding 7 days
Measured: 3 months after surgery (T2)
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
Measured: Baseline (T1)
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
Measured: 3 months after surgery (T2)
Brief Illness Perception Questionnaire
Self-report measure evaluating illness perceptions
Measured: Baseline (T1)
Brief Illness Perception Questionnaire
Self-report measure evaluating illness perceptions
Measured: 3 months after surgery (T2)
Pain Coping Inventory
Self-report measure assessing pain coping strategies
Measured: Baseline (T1)
Pain Coping Inventory
Self-report measure assessing pain coping strategies
Measured: 3 months after surgery (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Oct 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: Diffculty recruiting patients, limited timeframe to complete project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Jessica Van Oosterwijck, PhD, Study director, Ghent University; Research Foundation Flanders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022251
- Sponsor's protocol ID
- BC-08041
- Other IDs
- 3F014119
- Acronym
- DISC-PAIN
- Status last verified
- Dec 2023
- First submitted
- 12 May 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
- ClinicalTrials.gov ID
- NCT05022251
- Acronym / sponsor ID
- DISC-PAIN / BC-08041
- Conditions
- Lumbar Radiculopathy, Central Sensitisation
- Keywords
- lumbar radiculopathy, discectomy, central sensitization
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Diffculty recruiting patients, limited timeframe to complete project
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar radiculopathy | – | Procedure: Lumbar discectomyLumbar radiculopathy patients (n=122), 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 controls | – | –Sex, age, and BMI-matched healthy, pain-free control subjects (n=122) will be recruited for study participation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lumbar radiculopathy patients scheduled for first-time, single level, unilateral lumbar discectomy. Sex, age, and BMI matched healthy controls.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar discectomysurgically removing a hernia | Procedure or surgery | Lumbar radiculopathy |
Primary outcome
Quantitative sensory testing (QST) - electrical detection threshold
Time frame: Change from baseline (T1) at 3 months after surgery (T2)
Determination of sensory detection thresholds in response to electrical stimuli which are delivered transcutaneously over the n. suralis and n. medianus, recorded in mA.
Quantitative sensory testing (QST) - electrical pain threshold
Time frame: Change from baseline (T1) at 3 months after surgery (T2)
Determination of sensory pain threshold in response to electrical stimuli which are delivered transcutaneously over the n. suralis and n. medianus, recorded in mA.
Quantitative sensory testing (QST) - thermal detection threshold
Time frame: Change from baseline (T1) at 3 months after surgery (T2)
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
Quantitative sensory testing (QST) - thermal pain threshold
Time frame: Change from baseline (T1) at 3 months after surgery (T2)
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
Quantitative sensory testing (QST) - discrimination between thermal stimuli
Time frame: Change from baseline (T1) at 3 months after surgery (T2)
Determination of the number of paradoxical heat sensations in response to alternating cold and warm stimuli delivered to the skin using a thermode.
Quantitative sensory testing (QST) - tactile detection threshold
Time frame: Change from baseline (T1) at 3 months after surgery (T2)
Determination of tactile detection threshold, assessed using Von Frey monofilaments, recorded in mN
Quantitative sensory testing (QST) - mechanical pain threshold
Time frame: Change from baseline (T1) at 3 months after surgery (T2)
Determination of mechanical pain threshold, assessed using pinprick stimulators, recorded in mN
Quantitative sensory testing (QST) - sensitivity to pressure stimuli
Time frame: Change from baseline (T1) at 3 months after surgery (T2)
Determination of pressure pain threshold, assessed using pressure algometry, recorded in kg
Quantitative sensory testing (QST) - temporal summation of electrical stimuli
Time frame: Change from baseline (T1) and 3 months after surgery (T2)
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.
Quantitative sensory testing (QST) - temporal summation of mechanical stimuli
Time frame: Change from baseline (T1) and 3 months after surgery (T2)
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.
Quantitative sensory testing (QST) - spinal hyperexcitability
Time frame: Change from baseline (T1) and 3 months after surgery (T2)
Determination of spinal hyperexcitability using the nociceptive flexion reflex (NFR; sensitization of spinal cord neurons), recorded in mA
Quantitative sensory testing (QST) - temporal summation of spinal hyperexcitability
Time frame: Change from baseline (T1) and 3 months after surgery (T2)
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)
Quantitative sensory testing - conditioned pain modulation
Time frame: Change from baseline (T1) and 3 months after surgery (T2)
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.
20 secondary outcomes
Central sensitization inventory
Time frame: Baseline (T1)
Central sensitization inventory
Time frame: 3 months after surgery (T2)
Douleur Neuropathique 4 Questionnaire
Time frame: Baseline (T1)
Douleur Neuropathique 4 Questionnaire
Time frame: 3 months after surgery (T2)
Pain catastrophizing scale
Time frame: Baseline (T1)
Pain catastrophizing scale
Time frame: 3 months after surgery (T2)
Pain vigilance and awareness questionnaire
Time frame: Baseline (T1)
Pain vigilance and awareness questionnaire
Time frame: 3 months after surgery (T2)
Oswestry disability index
Time frame: Baseline (T1)
Oswestry disability index
Time frame: 3 months after surgery (T2)
Tampa scale for kinesiophobia
Time frame: Baseline (T1)
Tampa scale for kinesiophobia
Time frame: 3 months after surgery (T2)
International physical activity questionnaire
Time frame: Baseline (T1)
International physical activity questionnaire
Time frame: 3 months after surgery (T2)
Patient-reported outcomes measurement information system
Time frame: Baseline (T1)
Patient-reported outcomes measurement information system
Time frame: 3 months after surgery (T2)
Brief Illness Perception Questionnaire
Time frame: Baseline (T1)
Brief Illness Perception Questionnaire
Time frame: 3 months after surgery (T2)
Pain Coping Inventory
Time frame: Baseline (T1)
Pain Coping Inventory
Time frame: 3 months after surgery (T2)
Results and safety
The study was stopped early (reason given: Diffculty recruiting patients, limited timeframe to complete project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Van Oosterwijck, PhD study director
Ghent University; Research Foundation Flanders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Radiculopathy and Central Sensitisation, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Diffculty recruiting patients, limited timeframe to complete project). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative sensory testing (QST) - electrical detection threshold (time frame: Change from baseline (T1) at 3 months after surgery (T2)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.