QSTROBOT: Impact on Pain Sensitivity of Clinical Interaction

Sponsor
Spine Centre of Southern Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT04888026
Collaborator
University of Southern Denmark (Other)
87
3
3
17.7
29
1.6

Study Details

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:
  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)

Condition or Disease Intervention/Treatment Phase
  • Device: Quantitative sensory testing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
87 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Impact on Pain Sensitivity of Clinical Interaction
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The Conditioned pain modulation effect [changes in kPa] [Baseline]

    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

  1. Pressure pain threshold [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Spine Centre of Southern Denmark Middelfart Denmark 5500
2 The Spine Center of Southern Denmark Middelfart Denmark 5500
3 Department of Physocolgy Odense Denmark 5230

Sponsors and Collaborators

  • Spine Centre of Southern Denmark
  • University of Southern Denmark

Investigators

  • Principal Investigator: Søren Neill, PhD, Director of research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Spine Centre of Southern Denmark
ClinicalTrials.gov Identifier:
NCT04888026
Other Study ID Numbers:
  • QSTROBOT
First Posted:
May 17, 2021
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Spine Centre of Southern Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022