Impact on Pain Sensitivity of Clinical Interaction

NCT ID: NCT04888026

Last Updated: 2022-12-20

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2022-03-01

Brief Summary

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Pain can currently be quantified using quantitative sensory tests (QSTs). However, we lack knowledge concerning how relational and contextual factors impact these quantitative tests. We will examine how a standard QST battery is affected by "removing" the social and human interaction from the test session compared to usual QST testing where the participant is guided through the assessment by a research assistant.

Our objectives are:

1. How is the QST affected when guided by a research assistant compared to guided by a computer
2. Does the level of the assessor's empathy affect the QST outcome
3. How do psychological factors affect the QST testing
4. are these outcomes affected by the patient profile (low back pain patients vs healthy controls)

Detailed Description

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Conditions

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Pain Measurement

Keywords

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Low back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Automated QST procedure

The QST robot will autonomously perform i) pressure pain thresholds at the tibialis anterior, ii) the cold-pressor test, and iii) repeat the pressure pain threshold. All verbal information is giving through the computer

Group Type EXPERIMENTAL

Quantitative sensory testing

Intervention Type DEVICE

The following QSTs are conducted:

The pressure pain threshold on the tibialis anterior

The Cold-pressor test

Repeat of the pressure pain threshold to assess conditioned pain modulation

Manual QST procedure

The research assistant will perform i) pressure pain thresholds at the tibialis anterior, ii) the cold-pressor test, and iii) repeat the pressure pain threshold. All tests are performed manually without using the robot.

Group Type ACTIVE_COMPARATOR

Quantitative sensory testing

Intervention Type DEVICE

The following QSTs are conducted:

The pressure pain threshold on the tibialis anterior

The Cold-pressor test

Repeat of the pressure pain threshold to assess conditioned pain modulation

Semi-automated QST procedure

The QST robot will with guidance from the research assistant perform i) pressure pain thresholds at the tibialis anterior, ii) the cold-pressor test, and iii) repeat the pressure pain threshold. However and in contrast to the first arm, all verbal information and procedure guiding is given by a research assistant.

Group Type ACTIVE_COMPARATOR

Quantitative sensory testing

Intervention Type DEVICE

The following QSTs are conducted:

The pressure pain threshold on the tibialis anterior

The Cold-pressor test

Repeat of the pressure pain threshold to assess conditioned pain modulation

Interventions

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Quantitative sensory testing

The following QSTs are conducted:

The pressure pain threshold on the tibialis anterior

The Cold-pressor test

Repeat of the pressure pain threshold to assess conditioned pain modulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary complaint of low back pain
* No pain for healthy controls
* No serious psychological or somatic disorders potentially interfering with the QST

Exclusion Criteria

* Incomplete QST data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Spine Centre of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Søren Neill, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of research

Locations

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Spine Centre of Southern Denmark

Middelfart, , Denmark

Site Status

The Spine Center of Southern Denmark

Middelfart, , Denmark

Site Status

Department of Physocolgy

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Nim CG, Ravn SL, Andersen TE, Engelsholm E, Hestbech F, Hvidkaer IS, Traidl AN, O'Neill S. No effect of social interaction on experimental pain sensitivity: a randomized experimental study. Pain. 2023 Sep 1;164(9):2112-2121. doi: 10.1097/j.pain.0000000000002913. Epub 2023 Apr 13.

Reference Type DERIVED
PMID: 37058414 (View on PubMed)

Other Identifiers

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QSTROBOT

Identifier Type: -

Identifier Source: org_study_id