Impact on Pain Sensitivity of Clinical Interaction (QSTROBOT)

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)

Study Overview

• Status: Completed
• Conditions: Pain Measurement
• Intervention / Treatment: Device: Quantitative sensory testing

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Søren O'Neill, PhD; Phone Number: 45 40432004; Email: soeren.oneill@rsyd.dk

Study Locations

• Denmark
  • Middelfart, Denmark, 5500
    • Spine Centre of Southern Denmark
  • Middelfart, Denmark, 5500
    • The Spine Center of Southern Denmark
  • Odense, Denmark, 5230
    • Department of Physocolgy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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
Active Comparator: 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.	Device: 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
Active Comparator: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold	Between-group differences in pressure pain threshold [range 0-1000 kPa] as measured before the cold pressor test	Baseline

Collaborators and Investigators

• Sponsor: Spine Centre of Southern Denmark
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Søren Neill, PhD, Director of research

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Low back pain
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: QSTROBOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data is available upon reasonable request after the pre-planned analysis are performed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No