1. Tapentadol produces effective pain relief 2. Tapentadol treatment improves/enlarges CPM resonses 3. Tapentadol treatment improves/reduces temporal summation responses 4. Tapentadol treatment improves/reduces offset analgesia responses 5.…
ID
Bron
Verkorte titel
Aandoening
Fibromyalgia
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 term of endogenous pain modulation (CPM, OA), temporal summation, C-fiber density in the cornea, neuropathic pain symptoms and mood-related symptoms.
In case of an absent CPM a patients is 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), until one month after the medication is stopped.
Doel van het onderzoek
1. Tapentadol produces effective pain relief
2. Tapentadol treatment improves/enlarges CPM resonses
3. Tapentadol treatment improves/reduces temporal summation responses
4. Tapentadol treatment improves/reduces offset analgesia responses
5. Tapentadol is most efficacious in patients with initial defects in CPM and/or in patients that have a neuropathic pain component
Onderzoeksopzet
Patients will be treated for 3 months. Once a month the will visit the hospital to test CPM, TS and OA until one month after the medication is stopped.
Onderzoeksproduct en/of interventie
Patients will be 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.
Patients need to have a pain score ≥ 5 (on a scale of 0-10) for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria. Patients need to have a 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.
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 | NL5902 |
| NTR-old | NTR6090 |
| Ander register | LUMC : P15.361 |