Impact on Pain Sensitivity of Clinical Interaction

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04888026

Acronym

QSTROBOT

Enrollment

Registered

2021-05-17

Start date

2021-05-10

Completion date

2022-03-01

Last updated

2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Measurement

Keywords

Low back pain

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)

Interventions

DEVICEQuantitative sensory testing

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026