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The LCAT study


- candidate number25564
- NTR NumberNTR6521
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-nov-2016
- Secondary IDsP15.362 LUMC
- Public TitleThe LCAT study
- Scientific TitleA randomized, double blind, placebo-controlled study on the effect of 3 months treatment with the analgesic tapentadol on conditioned pain modulation (CPM) and pain relief in patients with chronic low back pain
- ACRONYMLCAT (Low back pain, CPM, Analgesia, Tapentadol)
- hypothesis1. Tapentadol produces effective pain relief in low back pain patients
2. Tapentadol treatment improves/enlarges CPM in patients with CPM defects
3. Tapentadol treatment improves/reduces temporal summation
4. Tapentadol is most efficacious in patients with initial defects in CPM and/or in patients that have a neuropathic pain component.
- Healt Condition(s) or Problem(s) studiedLow back pain (LBP)
- Inclusion criteriaAmerican Society of Anesthesiologists class 1 and 2 patients, 18 75 years; BMI < 40 kg/m2, and ability to give informed consent. Chronic Low Back Pain for > 3-months with a pain score of 5 or more on a numerical rating scale ranging from 0 (= no pain) to 10 (= most extreme pain imaginable).
To be enrolled in the study, patients need to have an absent/inactive CPM response.
- Exclusion criteriaUnable to give written informed consent; medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular disease; (iii) allergy to study medication; (iv) history of illicit drug abuse or alcohol abuse; (v) history of psychosis; (vi) epilepsy; (vii) pregnancy and/or lactation; (viii) strong opioids and benzodiazepine use; (ix) previous extensive spinal surgery or spinal surgery in the past 6 months; (x) serious spinal pathology and (xi) diagnosed neurological disease.
Patients are not allowed to continue co-analgesics that target CPM.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-okt-2016
- planned closingdate1-dec-2018
- Target number of participants40
- InterventionsPatients are treated with a placebo or Tapentadol for 3 months.
- Primary outcome- Conditioned Pain Modulation (CPM)
- Temporal summation (TS)
- Offset Analgesia (OA)
- Pain relief
- Secondary outcome- Pain Detect questionnaire
- The Big Five Inventory
- Profile Of Mood States
- Neuropathic Pain Symptoms Inventory Questionnaire
- Hospital Anxiety and Depression Scale (HADS)
- C-fiber density in the cornea
- TimepointsPatients are treated for 3 months. Before the start of the treatment and once a month during treatment patients will visit the hospital to test CPM, Temporal Summation and Offset Analgesia. One month after the treatment is stopped CPM, TS and OA are tested one final time.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M. Niesters
- CONTACT for SCIENTIFIC QUERIESDr. M. Niesters
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryPatients will be phenotyped in terms of endogenous pain modulation (CPM, Offset Analgesia), temporal summation, C-fiber density in the cornea, neuropathic pain symptoms and mood-related symptoms.
In case of an absent CPM patients are included and randomized to receive either placebo or Tapentadol. Patients are treated for 3 months, they will visit the clinic monthly to preform tests (CPM, OA, TS, questionnaires), one month after the treatment is stopped patients are tested one final time.
- Main changes (audit trail)
- RECORD22-nov-2016 - 14-jul-2017


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