Clinical trial NCT04323293: Pain Modulation - Experimental Assessments Using Different Modalities
Official title: Pain Modulation - Experimental Assessments Using Different Modalities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Compare Pain Modulation Assessments in Pain-free Cohorts
Keywords: low back pain
temporal summation of pain
conditioned pain modulation
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 705
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants (pain-free controls or patients with low back pain) will undergo either only one intervention (cold water bath) or two interventions in randomized order (cold water bath, water bath of neutral temperature as SHAM condition).
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Temporal Summation of Pain (TSP)
timeFrame: 1-4 weeks
measure: Conditioned Pain Modulation (CPM)
timeFrame: 1-4 weeks
measure: CPM effect on TSP
timeFrame: 1-4 weeks
Secondary outcomes:
measure: Pressure sensory and pain sensitivity
timeFrame: 1-4 weeks
measure: Mechanical sensory and pain sensitivity
timeFrame: 1-4 weeks
measure: Heat sensory and pain sensitivity
timeFrame: 1-4 weeks
measure: Electrical sensory and pain sensitivity
timeFrame: 1-4 weeks
measure: Pain Catastrophizing
timeFrame: 1-4 weeks
measure: Fear of pain
timeFrame: 1-4 weeks
measure: Anxiety
timeFrame: 1-4 weeks
measure: Depression
timeFrame: 1-4 weeks
measure: Pain duration
timeFrame: 1-4 weeks
measure: Spatial pain extent
timeFrame: 1-4 weeks
measure: Somatic symptoms
timeFrame: 1-4 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Integrative Spinal Research, Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich
name: Petra Schweinhardt, PhD
role: PRINCIPAL_INVESTIGATOR
References: