EFFECTS OF TAPENTADOL ON CHRONIC PAIN AND PARAMETERS OF CENTRAL SENSITIZATION. A PROSPECTIVE, OPEN LABEL, RANDOMIZED CROSS-OVER STUDY WITH PREGABALIN AS COMPARATOR,

Recruiting

Conditions: Anesthesiologie, chronische pijn
central sensibilisation
Chronic pain
10029305

Registration Number: NL-OMON48981

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Gender: female
2. Age: 18 years and older
3. Presence of proven endometriosis or CLBPr
4. Signs of central sensitization
5. No contraindications for opioids or pregabalin.
6. Signed informed consent.

Exclusion Criteria

1. No or insufficient understanding of Dutch language.
2. Incapacity to follow instructions.
3. Mental incompetence to provide informed consent.
4. CLBP with radiation to both legs.
5. Pain in one (or more) sites where QST will be applied.
6. Usage of opioids with more powerful spectre, such as oxycodone, fentanyl, morphine in the week prior to start of the study.
7. Previous usage of pregabalin or tapentadol
8. Alcohol abuse.
9. Pregnancy or woman who wish to be pregnant.
10. Kidney and/or liver function disturbances in patients with a medical history (<6 months) of kidney and liverdisturbances

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Central Sensitisation parameters<br /><br>• pressure pain threshold (PPT)<br /><br>• pressure pain tolerance threshold (PTT)<br /><br>• conditioned pain modulation (CPM)<br /><br>• size of allodynia<br /><br>• Wind-up ratio<br /><br>• CSI</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• NRS<br /><br>• PDI<br /><br>• PCS<br /><br>• PVAQ<br /><br>• Adverse effects of the medications<br /><br>• Dosages of the medication during the treatment period</p><br>