(1) To phenotype fibromyalgia patients in terms of endogenous modulation of pain, central sensitization/facilitation, the presence of a neuropathic pain component and small fiber neuropathy;(2) To assess the effect of a three-month treatment with…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endogenous pain modulation (CPM) and pain relief by tapentadol vs placebo
Secondary outcome
Endogenous pain modulation (OA) and central sensitization
C-fiber morphology in the cornea
Effect of tapentadol on mood and neuropathic pain complaints
Background summary
The current study has two parts. In part 1 we will phenotype the patients in
terms of
(#1) Endogenous pain modulation by measurement of conditioned pain modulation
and offset analgesia;
(#2) Temporal summation (a measurement of central sensitization);
(#3) C-fiber density in the cornea;
(#4) Neuropathic pain symptoms using PainDetect and Neuropathic Pain Symptom
Inventory (NPSI) questionnaires*
(#5) 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 modulation of pain (#1), central
sensitization/facilitation (#2), the presence of a neuropathic pain component
(#3 and #4) and mood disorders (#5).
Item #1 will be used as inclusion criterion and only patients with absent CPM
will be included in the study. Items #2-#5 will not be used as in- or exclusion
criteria but they (excl. test #3) will be followed over time during treatment
(at 1 month intervals) to assess the effect of tapentadol (relative to placebo)
on the biomarkers of chronic pain.
In part 2, patients will be treated with tapentadol sustained relief tablets.
They will ingest the medication twice daily for 3 months time. An initial
titration phase of 3 weeks will be followed by 9 weeks of treatment. Patients
will be contacted weekly by phone to report pain scores, and will visit the
clinic monthly to perform test #1-#5 (excl. test #3). Offset analgesia will be
tested only at baseline and after 3 months of treatment with
tapentadol/placebo. Finally, all patients will be tested for CPM and offset
analgesia (#1), temporal summation (#2) and questionnaires (#4 and #5) at a
final visit, one month after termination of treatment.
Study objective
(1) To phenotype fibromyalgia patients in terms of endogenous modulation of
pain, central sensitization/facilitation, the presence of a neuropathic pain
component and small fiber neuropathy;
(2) To assess the effect of a three-month treatment with tapentadol on pain
relief and conditioned pain modulation in patients with fibromyalgia and
defects in CPM;
(3) To asses whether specific factors derived from phenotypic baseline testing
predict a response to tapentadol in fibromyalgia patients.
Study design
Double blind, randomized and placebo controlled
Intervention
1. 2 months oral treatent with tapentadol
2. Tests for endogenous pain modulation (CPM and OA) and central sensitization
(Wind-up)
3. Cornea photos (to assess C-fiber morphology)
4. Questionanires to assess neuropathic pain complaints and mod.
Study burden and risks
Patients might experience some dizziness and constipation early on during
treatment but it is expected that tehse complaints dissipate over time.
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.
Additionally 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
-defects in CPM
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.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2015-005258-37-NL |
| CCMO | NL55837.058.15 |