Pain Modulation - Experimental Assessments Using Different Modalities

NCT04323293 | Unknown DMC

• 1 other identifier: Pain modulation assessments
• Study Type: interventional
• Target: 705
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

low back pain; temporal summation of pain; conditioned pain modulation

Outcome Measures

Primary Outcomes (3)

• Temporal Summation of Pain (TSP)

  TSP is measured as the change in perceived pain over time in response to repetitive noxious stimulation. In this study, a series of stimulations will be applied using different modalities (pressure, superficial mechanical, heat or electrical stimuli). Participants will be asked to report the perceived pain in response to the stimulations on an 11-point numerical rating scale (0: no pain, 10: most intense pain) or a visual analogue scale (VAS). VAS will be anchored with 0 ("no sensation"), 40 ("just painful," defined as the pain threshold), and 100 ("most intense pain tolerable"). Reflex parameters (thresholds in milliampere (mA); amplitude in μV) will be recorded at start and end of the series. Differences in read-outs (pain ratings, reflex thresholds or reflex amplitudes) at the start of the series compared to the end of the series or the slope of the pain ratings over the series will serve as TSP measures. Greater differences (end-start) or steeper slopes represent a greater TSP.

  1-4 weeks

• Conditioned Pain Modulation (CPM)

  CPM measures the modulation of a noxious test stimulus by another noxious conditioning stimulus applied at a remote body region. In this study, test stimuli of different modalities (pressure, superficial mechanical, heat or electrical stimuli) will be applied at different body regions before and after or before, during and after a cold water bath or neutral water bath (hand immersion) as conditioning stimulus. Changes in test stimuli read-outs (during-before or after-before) will serve as CPM measure. Negative changes represent inhibitory, positive changes facilitatory CPM effects. For all test stimuli read-outs, CPM effects will be expressed as percentage changes. Test stimuli read-outs include: pain ratings (numerical rating scale or VAS, anchors see TSP outcome); perception thresholds (in kg for pressure, millinewton for superficial mechanical, °C for heat and mA for electrical stimuli); pain thresholds; reflex parameters (thresholds in mA and/or amplitudes).

  1-4 weeks

• CPM effect on TSP

  Changes in TSP in response to the intervention (conditioning stimulus: cold water bath or SHAM).

  1-4 weeks

Secondary Outcomes (11)

• Pressure sensory and pain sensitivity

  1-4 weeks

• Mechanical sensory and pain sensitivity

  1-4 weeks

• Heat sensory and pain sensitivity

  1-4 weeks

• Electrical sensory and pain sensitivity

  1-4 weeks

• Pain Catastrophizing

  1-4 weeks

Study Arms (2)

CPM - Cold Water Bath

EXPERIMENTAL

Other: Cold Water Bath

CPM - SHAM

SHAM COMPARATOR

Other: Neutral Water Bath

Interventions

Cold Water Bath OTHER

immersion of the hand for 2-5min in 2-10°C water

CPM - Cold Water Bath

Neutral Water Bath OTHER

immersion of the hand for 2-5min in 32±2°C water

CPM - SHAM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Schweinhardt Petra: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Petra Schweinhardt, PhD

  Integrative Spinal Research, Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Schweinhardt, PhD

CONTACT

+41 44 510 73 81; petra.schweinhardt@balgrist.ch

Luana Nyirö, DCM

CONTACT

+41 44 386 57 28; luana.nyiroe@balgrist.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are unaware of the hypothesis. Outcomes assessors in subprojects are blind to the type of the water bath.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research Department of Chiropractic Medicine

Model Details: 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).

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 26, 2020
• Study Start: May 1, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

CH (1)