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| ID | Type | Description | Link |
|---|---|---|---|
| 3F014119 | Other Grant/Funding Number | Research Foundation - Flanders (FWO) |
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Diffculty recruiting patients, limited timeframe to complete project
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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Healthy controls | Sex, age, and BMI-matched healthy, pain-free control subjects (n=122) will be recruited for study participation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar discectomy | Procedure | surgically removing a hernia |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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:
| 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:
| 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. | Change from baseline (T1) at 3 months after surgery (T2) |
| Quantitative sensory testing (QST) - tactile detection threshold |
| Measure | Description | Time Frame |
|---|---|---|
| Central sensitization inventory | Self-report measure of signs and symptoms associated with central sensitization | Baseline (T1) |
| Central sensitization inventory | Self-report measure of signs and symptoms associated with central sensitization |
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Inclusion Criteria:
Exclusion Criteria:
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Lumbar radiculopathy patients scheduled for first-time, single level, unilateral lumbar discectomy.
Sex, age, and BMI matched healthy controls.
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Van Oosterwijck, PhD | Ghent University; Research Foundation Flanders | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University (Hospital) | Ghent | Belgium |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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Determination of tactile detection threshold, assessed using Von Frey monofilaments, recorded in mN |
| 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 | 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 | 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. | 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. | 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 | 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) | 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. | Change from baseline (T1) and 3 months after surgery (T2) |
| 3 months after surgery (T2) |
| Douleur Neuropathique 4 Questionnaire | Clinician administered questionnaire for evaluation of signs and symptoms associated with neuropathic pain | Baseline (T1) |
| Douleur Neuropathique 4 Questionnaire | Clinician administered questionnaire for evaluation of signs and symptoms associated with neuropathic pain | 3 months after surgery (T2) |
| Pain catastrophizing scale | Self-report measure of pain perceptions and cognitions | Baseline (T1) |
| Pain catastrophizing scale | Self-report measure of pain perceptions and cognitions | 3 months after surgery (T2) |
| Pain vigilance and awareness questionnaire | Self-report measure assessing preoccupation with and attention to pain | Baseline (T1) |
| Pain vigilance and awareness questionnaire | Self-report measure assessing preoccupation with and attention to pain | 3 months after surgery (T2) |
| Oswestry disability index | Self-report measure evaluating low back pain related disability | Baseline (T1) |
| Oswestry disability index | Self-report measure evaluating low back pain related disability | 3 months after surgery (T2) |
| Tampa scale for kinesiophobia | Self-report measure assessing fear of movement | Baseline (T1) |
| Tampa scale for kinesiophobia | Self-report measure assessing fear of movement | 3 months after surgery (T2) |
| International physical activity questionnaire | Self-report measure of physical activity in preceeding 7 days | Baseline (T1) |
| International physical activity questionnaire | Self-report measure of physical activity in preceeding 7 days | 3 months after surgery (T2) |
| Patient-reported outcomes measurement information system | Self-report measure of health-related domains including:
| Baseline (T1) |
| Patient-reported outcomes measurement information system | Self-report measure of health-related domains including:
| 3 months after surgery (T2) |
| Brief Illness Perception Questionnaire | Self-report measure evaluating illness perceptions | Baseline (T1) |
| Brief Illness Perception Questionnaire | Self-report measure evaluating illness perceptions | 3 months after surgery (T2) |
| Pain Coping Inventory | Self-report measure assessing pain coping strategies | Baseline (T1) |
| Pain Coping Inventory | Self-report measure assessing pain coping strategies | 3 months after surgery (T2) |