Pain Modulation - Experimental Assessments Using Different Modalities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

705 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes

NCT01346202

Chronic Pain

COMPLETED

Pain Processing In Relation To Breathing

NCT06169917

Central Sensitisation Pain

RECRUITING NA

Pain Perception and the Autonomic Nervous System

NCT06667895

Autonomic Nervous System Modulation Pain Perception Pain Sensitivity +2 more

NOT_YET_RECRUITING NA

Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain

NCT05972395

Chronic Low-back Pain

UNKNOWN

Reliability of Measuring Conditioned Pain Modulation With the Nociceptive Withdrawal Reflex

NCT01636440

Healthy Volunteers

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants are unaware of the hypothesis. Outcomes assessors in subprojects are blind to the type of the water bath.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CPM - Cold Water Bath

Group Type EXPERIMENTAL

Cold Water Bath

Intervention Type OTHER

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

CPM - SHAM

Group Type SHAM_COMPARATOR

Neutral Water Bath

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cold Water Bath

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

Intervention Type OTHER

Neutral Water Bath

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes