No registrations found.
ID
Source
Brief title
Health condition
Fibromyalgia
Sponsors and support
Intervention
Outcome measures
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
Background summary
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.
Study objective
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
Study design
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.
Intervention
Patients will be treated with a placebo or Tapentadol for 3 months.
M. Niesters
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
071-5262301
m.niesters@lumc.nl
M. Niesters
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
071-5262301
m.niesters@lumc.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5902 |
| NTR-old | NTR6090 |
| Other | LUMC : P15.361 |