Impact on Pain Sensitivity of Clinical Interaction

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

Official Title
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Impact on Pain Sensitivity of Clinical Interaction

Conditions
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Pain Measurement

Intervention / Treatment
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* Device: Quantitative sensory testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated QST procedure<br>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<br>* 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<br>|
| Active Comparator: Manual QST procedure<br>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<br>* 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<br>|
| Active Comparator: Semi-automated QST procedure<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain