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Pain Modulation - Experimental Assessments Using Different Modalities

S

Schweinhardt Petra

Status

Enrolling

Conditions

Compare Pain Modulation Assessments in Pain-free Cohorts
Low Back Pain

Treatments

Other: Neutral Water Bath
Other: Cold Water Bath

Study type

Interventional

Funder types

Other

Identifiers

NCT04323293
Pain modulation assessments

Details and patient eligibility

About

The goal of this study is to investigate how different painful stimuli are processed and modulated in the nervous system. In various pain conditions, including low back pain, often no specific source can be identified as the cause of the pain. Scientific findings point towards a possible involvement of sensitization processes in the central nervous system (spinal cord and brain) that can contribute to the development and persistence of chronic pain. There is a need for reliable and well established experimental methods to better investigate and understand these processes. Frequently used methods comprise the application of thermal, mechanical or electrical stimulations. These modalities are processed in different parts of the nervous system, each allowing its own conclusions. This can be an advantage, but it also poses a challenge regarding comparability and generalizability of obtained results.

This study aims to apply and compare various experimental methods in people without and people with low back pain and shed light on the methodological differences. In the future, this could enable better identification and characterization of sensitization processes in the nervous system and build the basis for individually adapted, mechanism-targeted treatments with better patient outcomes.

Enrollment

705 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • German or English proficiency
  • Informed consent
  • primary pain complaint localized between the 12th rib and the gluteal fold
  • low back pain for more than one week
  • low back pain clinically not attributable to "red flags" (including infection, trauma, fractures, inflammatory)

Exclusion criteria

  • unable to give informed consent (e.g. due to language problems)
  • any neurological condition
  • any major medical or psychiatric condition (e.g. severe heart disease, diabetes, autoimmune disorders, major depressive disorder), any chronic pain condition other than low back pain
  • pregnancy
  • Radiating pain below knee level (radicular pain)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

705 participants in 2 patient groups

CPM - Cold Water Bath
Experimental group
Treatment:
Other: Cold Water Bath
CPM - SHAM
Sham Comparator group
Treatment:
Other: Neutral Water Bath

Trial contacts and locations

1

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Central trial contact

Luana Nyirö, DCM; Petra Schweinhardt, PhD

Data sourced from clinicaltrials.gov

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