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OpenTrials
Completed

NCT Number: NCT04888026

Impact on Pain Sensitivity of Clinical Interaction

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)

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Key information

Conditions

Pain Measurement Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine Centre of Southern Denmark, Middelfart, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Pressure pain threshold

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Spine Centre of Southern Denmark

Other

Collaborators

  • University of Southern Denmark

Registry information

Acronym: QSTROBOT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2021
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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