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Central sensitisation in patients with chronic low back pain radiating to the leg


- candidate number28306
- NTR NumberNTR6865
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2017
- Secondary IDsNL60439.042.17 
- Public TitleCentral sensitisation 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
- ACRONYMCLaSSICO
- hypothesisThe extent of central sensitisation (CS) in patients with chronic low back pain radiating to the leg (CLBPr), its role in chronification and its interaction with diagnostic and therapeutical internevtions are unknown up to now. Therefore, the main questions of this study are: can we find signs of CS in patients with CLBPr? Can we quantify it? Do the interventions therapeutic segmental nerve root block (tSNRB) and pulsed radiofrequency (pRF) normally applied in care as usual (CaU) affect CS?
- Healt Condition(s) or Problem(s) studiedLow back pain (LBP), Irradiating pain
- Inclusion criteriaPresence of CLBP with radiation to the leg below the knee; Leg pain > back pain; Physician must consider tSNRB or pRF as an appropriate treatment intervention; Age: 18-65 years old; Agreement and signature of the informed consent.
- Exclusion criteriaExclusion criteria for segmental nerve blocks (see our local protocols); 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
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate31-dec-2019
- Target number of participants100
- Interventions- Bedside examination (BSE): following the orientations given by the German Research Network on Neuropathic Pain (DFNS);
- Quantitative Sensory Testing (QST) measurements: 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 bedside clinical examination of the somatosensory system;
- Central Sensitization Inventory (CSI);
- 36-Item Short Form Health Survey (SF-36): also known as RAND-36;
- Pain Disability Index (PDI);
- Work Ability Index (WAI);
- StarT Back Screening Tool (SBST);
- Visual Analogue Scale for Pain (VAS);
- Drawing pain in standard leg images;
- Diagnostic segmental nerve root block (dSNRB) and tSNRB: see our local protocol;
- pRF: see our local protocol.
- Primary outcome- QST
- BSE
- CSI
- Secondary outcomeOther measurements (part of the standardised care or CaU) are: 36-Item Short Form Health Survey (SF-36), Pain Disability Index (PDI), Work Ability Index (WAI), STarT Back Screening Tool (SBST), Visual Analogue Scale for Pain (VAS) and drawing in standard leg images.
- TimepointsVisit 1 = t0 >>> A member of the research team will explain the details of the informed consent to the participant. If the participant agrees with the content of the informed consent, he/she will be asked to sign this document and the research team will start the baseline measurements.
Visit 2 = t1 >>> At their second visit (t1), patients will undergo dSNRB. Healthy control subjects will not undergo dSNRB, but will pass through the measurements.
Visit 3 = t2 >>> One week after the dSNRB, the third visit takes place (t2). During this visit, patients will receive one intervention: tSNRB or pRF. Healthy control subjects will not undergo tSNRB or pRF, but will pass through the measurements.
Visit 4 = t3 >>> Four weeks after the intervention, the last visit will take place (t3). The following measurements will be performed: QST, BSE, CSI, SBST, VAS back/leg, drawing pain area, SF-36, PDI and WAI.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES André Wolff
- CONTACT for SCIENTIFIC QUERIES Tharcila Chaves
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Brazilian Ministry of Education (PhD grant)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-dec-2017 - 14-dec-2017


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