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Effects of tapentadol on chronic pain and parameters of central sensitization.

Effects of tapentadol on chronic pain and parameters of central sensitization. A prospective, open label, randomaized cross-over study with pregabalin as comparator.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20680
Enrollment
60
Registered
2018-04-23
Start date
2019-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Chronic Pain, Central Sensitization, tapentadol, pregabalin

Interventions

- Tapentadol: Dose: start dose of 50mg 2x/day, increase by 50mg 2x/day every 3 days until sufficient analgesia is reached with tolerable adverse effects. Max 500 mg/day. Route: Oral administration

Sponsors

University Medical Center Groningen, dept of Anesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Gender: female - Age of patients (18-65 years old) - Presence of proven endometriosis or CLBPr - Signs of central sensitization - No contraindications for opioids or pregabalin. - Signed informed consent.

Exclusion criteria

Exclusion criteria: - No or insufficient understanding of Dutch language. - Incapacity to follow instructions. - Mental incompetence to provide informed consent. - CLBP with radiation to both legs. - Pain in the lower leg or at the deltoid muscle (sites for the QST measurement will be applied) - Usage of opioids with more powerful spectre, such as oxycodone, fentanyl, morphine in the two weeks prior to start of the study. - Previous usage of pregabalin or tapentadol - Alcohol abuse. - Pregnancy or woman who wish to be pregnant.

Design outcomes

Primary

MeasureTime frame
Central Sensitzation parameters - pressure pain threshold (PPT) - pressure pain tolerance threshold (PTT) - conditioned pain modulation (CPM) - size of allodynia - Wind-up ratio (WUR) - Central Sensitization Inventory (CSI)

Secondary

MeasureTime frame
- Visual Analog Scale (VAS) - Pain Disability Index (PDI) - Pain Catastrophizing Scale (PCS) - Pain Vigilance and Awareness Questionnaire (PVAQ) - Adverse effects of the medications - Dosages of the medication during the treatment period

Contacts

Public ContactR. Spanjersberg

Hanzeplein 1

r.spanjersberg@umcg.nl+31 (0)50 3611158

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)