The neurochemical basis of individual pain sensitivity and pain modulation, Part II, Study 1

Not Applicable

• Conditions: Healthy Participants

• Registration Number: DRKS00009637
• Lead Sponsor: niversitätsklinikum Essen, Klinik für Neurologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-26
• Study Completion: 2016-04-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Healthy.
• Age 18 to 40 years.
• for women: hormonal contraception.
• Written informed consent.

Exclusion Criteria

• Signs of renal, cardiovascular, or hepatic disease.
• Signs of raised intraocular pressure.
• Protein-rich diet before study-visit one.
• History of, or present neurologic disorders, e.g. pain disorders, migraine, lower back pain, irritable bowel syndrome, cranial trauma, epilepsia, or sleep disorder.
• History of, or present psychiatric disorder, e.g. depression, schizophrenia, substance abuse, or personality disorders.
• History of, or present severe internal disorders, such as diabetes, neoplasia, thyroid dysfunction, asthma.
• Acute infections (common cold, diarrhea).
• Alcohol consumtion at the day of or the day before study participation.
• Known allergy against any constituent of the study medication.
• Surgery requiring narcosis within the last 6 months.
• Participation in any study requiring the intake of study medication within the last 6 months.
• Any long-term medication, except dietary supplements and hormonal contraception.
• Intake of pain medication (e.g. NSAIDs) within the last 14 days.
• For women: Pregnancy.
• Disorders of the skin that could affect temperature sensation (e.g. neurodermitis).
• Abnormal pain- or temperature sensitivity at the forearm, defined as :
o Heat pain threshold > 50°C.
o Warmth detection threshold >37°C.
o Unstable heat pain ratings Unzuverlässige Differenzierung von Hitzereizen or VAS40<44.0°C oder VAS80>48.5°C.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome variable: Heat pain ratings (visal analog scale, 101-points) obtained for the skin patches with placebo treatment and the skin patch with control treatment at identical stimulus intensities.<br>Outcome comparison: The interaction effect between factors Group (between-subject, levels: LDopa, Placebo) and Patch (within-subject, levels: Placebo-Treatment, Control-Treatment) tested in a full-factorial Mixed-Model ANOVA with maximum random effects structure.