Investigating Composite Biomarkers for Pain Catastrophizing

Aalborg University

Status: Enrolling

Conditions: Pain, Acute

Treatments: Drug: isotonic saline; Drug: hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04787198

N-20200095

Details and patient eligibility

About

Pain is a complex, multidimensional, and subjective experience; and although, investigators use a single word "pain", to describe our perception, multiple mechanisms contribute to the generation and maintenance of pain. To help diagnosing and improving pain management, there is a need for developing tools. These tools may include measurements of substances, or biomarkers, in the blood; e.g. small molecules called microRNA and proteins. In these experiments, the investigators would like to investigate how the psychological response to stress and pain alters the impulses in the brain and the content of microRNA and proteins in the blood. The future aim is to identify patients in high risk of developing and maintaining chronic pain and to be able to treat chronic pain efficiently.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women in the age 18-80 years
• Speak and understand English

Exclusion criteria

• Acute and chronic pain
• Pregnancy or breastfeeding
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Present or previous history of neurological, dermatological, immunological, musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. Neuropathy, muscular pain in the upper extremities, etc.)
• Focal and generalized seizure
• Surgery or any other therapy for epilepsy
• Present or previous AEDs (anti-epileptic drugs) administration
• Present or previous use of epileptic devices (<1 year prior the enrolment)
• Lack of ability to cooperate
• Current use of medications that may affect the trial, such as antipsychotics and pain killers as well as systemic or topical steroids and anti-inflammatory drugs.
• Skin diseases
• Consumption of alcohol or painkillers 24 hours before the study days and between these
• Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups, including a placebo group

hypertonic saline

Experimental group

Treatment:

Drug: hypertonic saline

isotonic saline

Placebo Comparator group

Treatment:

Drug: isotonic saline