No registrations found.
ID
Source
Brief title
Health condition
Low back pain
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 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.
Study objective
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.
Study design
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.
Intervention
Patients are 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, 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 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; (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.
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 | NL6329 |
| NTR-old | NTR6521 |
| Other | LUMC : P15.362 |