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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48981
Enrollment
60
Registered
2018-07-22
Start date
2019-03-07
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesiologie, chronische pijn central sensibilisation Chronic pain

Interventions

For tapentadol we will start titrating with 50mg 2x/day and increase the dose by 50mg 2x/day every 3 days until sufficient analgesia is reached with tolerable adverse effects. The maximum recommende

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

MeasureTime frame
Central Sensitisation parameters • pressure pain threshold (PPT) • pressure pain tolerance threshold (PTT) • conditioned pain modulation (CPM) • size of allodynia • Wind-up ratio • CSI

Secondary

MeasureTime frame
• NRS • PDI • PCS • PVAQ • Adverse effects of the medications • Dosages of the medication during the treatment period

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)