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van CCT (UK)

van CCT (UK)

Investigating the sensitivity of the central nervous system in patients with chronic low back pain radiating to the leg

- candidate number28424
- NTR NumberNTR6942
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jan-2018
- Secondary IDsMETc 2017/420 METc Univeristy Medical Center Groningen
- Public TitleInvestigating the sensitivity of the central nervous system in patients with chronic low back pain radiating to the leg
- Scientific TitleCentral sensitisation in patients with chronic low back pain radiating to the leg
- hypothesisTo determine the presence or absence of central sensitisation in patients with Chronic Low Back Pain with radiation to the leg (CLBPr) and to determine the effect of segmental nerve interventions on central sensitisation.
- Healt Condition(s) or Problem(s) studiedChronic low backpain, Central sensitisation, Segmental nerve root block, Pulsed radiofrequency
- Inclusion criteria- Presence of CLBPr below the knee;
- Leg pain > back pain;
- Physician must consider therapeutic Sensory Nerve Root Blocking (SNRB) or pulsed RadioFrequency (pRF) as an appropriate treatment intervention;
- Age: 18-65 years old;
- Agreement and signature of the informed consent
- Exclusion criteria- Exclusion criteria for segmental nerve blocks (according to local protocol)
- No or not sufficient understanding of Dutch language;
- Incapacity to follow instructions;
- Mental incompetence to provide informed consent;
- CLBP with radiation to both legs;
- Pain in one (or more) sites where BSE and QST will be applied (except for the most painful point in the painful dermatome).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2018
- planned closingdate1-nov-2019
- Target number of participants100
- InterventionsThis study will include 50 patients and 50 age and gender matched controls.

Patients will receive care as usual. Segmental nerve intervention will be performed according to the standard procedures of the Anesthesiology Pain Center of the University Medical Center of Groningen:

dSNRB (diagnostic Sensory Nerve Root Block):
- Bupivacaine 0,75% 0,3ml with Visipaque 320 mg I/ml 0,3ml (total 0,6ml). Inject 0,35 0,55 ml in total

tSNRB (therapeutic Sensory Nerve Root Block):
-L3 and lower: Bupivacaine 7,5mg + Triamcinolon 40mg + Visipaque 320 mg I/ml together in one 5 ml syringe.
L2 and higher: Bupivacaine 7,5mg + Dexamethason 5mg + Visipaque 320 mg I/ml together in one 5 ml syringe.

pRF (pulsed RadioFrequency):
pulsed radiofrequency (20msec on, 480msec off)
on 45V during 4 min, temp <42 degrees Celcius

Pain and Quality of Life parameters will be collected to assess and quantify central sensitisation during several stages of the care as usual procedure.

Healthy control subjects will not receive any segmental nerve intervention, but will perform all other measurements on given timepoints.
- Primary outcome1. Quantitative Sensory Testing (QST; T0,T1,T2,T3)
2. Bedside Examination (BSE; T0,T1,T2,T3)
3. Central Sensitization Inventory (CSI; T1,T2,T3)
- Secondary outcome1.36-Item Short Form Health Survey (SF-36; T0,T3)
2.Pain Disability Index (PDI; T0,T3)
3.Work Ability Index (WAI; T0,T3)
4.STarT Back Screening Tool (SBST; T0,T3)
5.Visual Analogue Scale for Pain (VAS; T1,T2,T3)
6.Drawing in standard leg images (DPA; T1,T3)
- TimepointsT0=baseline measurements-training session QST
T1=measurements before diagnostic SNRB
T2=measurements 1 week after diagnostic SNRB, just before segmental nerve intervention
T3=measurement 4 weeks after segmental nerve intervention
- Trial web site-
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Education of Brazil - Science without Borders programme (project number 9140/13-1), University Medical Center Groningen (UMCG)
- Publications
- Brief summaryThere is growing evidence for sensitisation in patients with chronic pain. Continuing nociceptive inputs can induce a reduction in threshold and an increase in responsiveness of peripheral nociceptors, i.e. peripheral sensitisation, which on itself may lead to a prolonged increase in excitability and synaptic efficacy of neurons in central nociceptive pathways, i.e. central sensitisation. Several methods are advocated to measure central sensitisation. For example, quantitative sensory testing (QST) is a psychophysical method that objectively measures responses to calibrated graded innocuous or noxious stimuli and represents, in most respects, an extension of the routine standardised sensory measurements. Furthermore, central sensitisation can be assessed with the Central Sensitisation Inventory (CSI). For treatment of severe cases of chronic low back pain, patients are referred to multidisciplinary pain clinics for further assessment. If the diagnosis in patients with chronic low back pain radiating to the leg (CLBPr) is not clear despite extensive physical, neurological, orthopaedic and radiological examination, a precision diagnosis, such as diagnostic segmental nerve root block (dSNRB), has been advocated. After a positive dSNRB, possible interventions are therapeutic SNRB (tSNRB) or pulsed radiofrequency (pRF). The extent of central sensitisation in patients with CLBPr, its role in chronification and its interaction with diagnostic and therapeutical interventions are unknown up to now.
Therefore, the main questions of this study are: can we find signs of central sensitisation in patients with CLBPr? Can we quantify it? Do the interventions (tSNRB and pRF) normally applied in care as usual affect central sensitisation?
- Main changes (audit trail)
- RECORD10-jan-2018 - 19-jan-2018

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