Impact on Pain Sensitivity of Clinical Interaction (QSTROBOT)

Spine Centre of Southern Denmark

Status: Completed

Conditions: Pain Measurement

Treatments: Device: Quantitative sensory testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04888026

QSTROBOT

Details and patient eligibility

About

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)

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 3 patient groups

Automated QST procedure

Experimental group

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

Treatment:

Device: Quantitative sensory testing

Manual QST procedure

Active Comparator group

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.

Treatment:

Device: Quantitative sensory testing

Semi-automated QST procedure

Active Comparator group

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.

Treatment:

Device: Quantitative sensory testing