1. 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…
ID
Bron
Verkorte titel
Aandoening
Low back pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Conditioned Pain Modulation (CPM)<br>
- Temporal summation (TS)<br>
- Offset Analgesia (OA)<br>
- Pain relief
Achtergrond van het onderzoek
Patients 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.
Doel van het onderzoek
1. 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.
Onderzoeksopzet
Patients 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.
Onderzoeksproduct en/of interventie
Patients are treated with a placebo or Tapentadol for 3 months.
Publiek
M. Niesters
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
071-5262301
m.niesters@lumc.nl
Wetenschappelijk
M. Niesters
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
071-5262301
m.niesters@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
American 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Unable 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6329 |
| NTR-old | NTR6521 |
| Ander register | LUMC : P15.362 |