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Impact on Pain Sensitivity of Clinical Interaction (QSTROBOT)

Primary Purpose

Pain Measurement

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Quantitative sensory testing
Sponsored by
Spine Centre of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain Measurement focused on measuring Low back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spine Centre of Southern Denmark
  • The Spine Center of Southern Denmark
  • Department of Physocolgy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Automated QST procedure

Manual QST procedure

Semi-automated QST procedure

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

The Conditioned pain modulation effect [changes in kPa]
Between-group differences in conditioned pain modulation (CPM). The CPM [range -1000;1000 kPa] is measured as the change between a pressure pain threshold test before and after a cold pressor test (2 minutes of immersion the left hand in ice water].

Secondary Outcome Measures

Pressure pain threshold
Between-group differences in pressure pain threshold [range 0-1000 kPa] as measured before the cold pressor test

Full Information

First Posted
March 22, 2021
Last Updated
December 19, 2022
Sponsor
Spine Centre of Southern Denmark
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04888026
Brief Title
Impact on Pain Sensitivity of Clinical Interaction
Acronym
QSTROBOT
Official Title
Impact on Pain Sensitivity of Clinical Interaction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spine Centre of Southern Denmark
Collaborators
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Measurement
Keywords
Low back pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automated QST procedure
Arm Type
Experimental
Arm Description
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
Arm Title
Manual QST procedure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Semi-automated QST procedure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Quantitative sensory testing
Intervention Description
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
Primary Outcome Measure Information:
Title
The Conditioned pain modulation effect [changes in kPa]
Description
Between-group differences in conditioned pain modulation (CPM). The CPM [range -1000;1000 kPa] is measured as the change between a pressure pain threshold test before and after a cold pressor test (2 minutes of immersion the left hand in ice water].
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
Between-group differences in pressure pain threshold [range 0-1000 kPa] as measured before the cold pressor test
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Neill, PhD
Organizational Affiliation
Director of research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine Centre of Southern Denmark
City
Middelfart
ZIP/Postal Code
5500
Country
Denmark
Facility Name
The Spine Center of Southern Denmark
City
Middelfart
ZIP/Postal Code
5500
Country
Denmark
Facility Name
Department of Physocolgy
City
Odense
ZIP/Postal Code
5230
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is available upon reasonable request after the pre-planned analysis are performed

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Impact on Pain Sensitivity of Clinical Interaction

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