Impact on Pain Sensitivity of Clinical Interaction

NCT04888026 | Completed

• 1 other identifier: QSTROBOT
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 3

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

Conditions

Pain Measurement

Keywords

Low back pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pressure pain threshold

  Baseline

Study Arms (3)

Automated QST procedure

EXPERIMENTAL

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

Manual QST procedure

ACTIVE COMPARATOR

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

Semi-automated QST procedure

ACTIVE COMPARATOR

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

Interventions

Quantitative sensory testing 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

Automated QST procedure; Manual QST procedure; Semi-automated QST procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Incomplete QST data

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead
• University of Southern Denmark: collaborator

Study Sites (3)

Spine Centre of Southern Denmark

Middelfart, 5500, Denmark

Location

The Spine Center of Southern Denmark

Middelfart, 5500, Denmark

Location

Department of Physocolgy

Odense, 5230, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37058414 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Søren Neill, PhD

  Director of research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: May 17, 2021
• Study Start: May 10, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)