Impact on Pain Sensitivity of Clinical Interaction

Not Applicable

Completed

• Conditions: Pain Measurement
• Interventions: Device: Quantitative sensory testing

• Registration Number: NCT04888026
• Lead Sponsor: Spine Centre of Southern Denmark

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-22
• Study Start: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-17
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated QST procedure	Quantitative sensory testing	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
Manual QST procedure	Quantitative sensory testing	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.
Semi-automated QST procedure	Quantitative sensory testing	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (3)

Spine Centre of Southern Denmark; 🇩🇰 Middelfart, Denmark

The Spine Center of Southern Denmark; 🇩🇰 Middelfart, Denmark

Department of Physocolgy; 🇩🇰 Odense, Denmark