(1) To phenotype chronic low back pain patients in terms of endogenous modulation of pain, central sensitization/facilitation, and the presence of a neuropathic pain component;(2) To assess the effect of a three-month treatment with tapentadol on…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain relief and change in endogenous pain modulation
Secondary outcome
Change in mood. daily activity and neuropathic pain cmplaints
Background summary
The current study has two parts. In part 1 we will phenotype the patients in
terms of
(#1) Conditioned pain modulation
(#2) Offset analgesia
(#3) Temporal summation
(#4) Roland Morris Disability Questionairre which examines effects of LBP on
activities of daily living
(#5) Neuropathic pain symptoms using PainDetect and Neuropathic Pain Symptom
Inventory (NPSI) questionnaires*
(#6) Mood-related symptoms using Hopsital Anxiety and Depression Scale (HADS)
and Profile of Mood States (POMS) questionnaires.
Phenotyping is done to get an indication of the baseline state of the patients
in terms of endogenous pain modulation (#1 and 2), central
sensitization/facilitation (#3), daily functioning (#4), the presence of a
neuropathic pain component (#5) and mood disorders (#6).
Study objective
(1) To phenotype chronic low back pain patients in terms of endogenous
modulation of pain, central sensitization/facilitation, and the presence of a
neuropathic pain component;
(2) To assess the effect of a three-month treatment with tapentadol on pain
relief and endogenous pain modulation in patients with chronic low back pain
and defects in CPM;
(3) To assess whether specific factors derived from phenotypic baseline testing
predict a response to tapentadol in fibromyalgia patients.
Study design
Double-blind, placeo controlled, randomized
Intervention
1. Pain tests for measurement of endogenous pain modulation
2. Questionnaires to assess mood, daily activity and neuropathic pain complaints
3. Treatment with tapentadol for 3 months
Study burden and risks
Some dizziness and constipation is possible in the first weeks of the study but
we expect these complaints to dissipate witin weeks.
Benefit: Pain relief
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Age: 18 - 75 years.;- Sex: Either sex.
- Inclusion criteria: American Society of Anesthesiologists class 1 and 2 patients, 18 - 75 years; BMI < 40 kg/m2, and ability to give informed consent. CLBP for > 3-months with a pain score of 3 or more on a numerical rating scale.
.
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.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005259-28-NL |
| CCMO | NL55839.058.15 |