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Clinical Trials/NCT04888026
NCT04888026
Completed
Not Applicable

Impact on Pain Sensitivity of Clinical Interaction

Spine Centre of Southern Denmark3 sites in 1 country87 target enrollmentMay 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain Measurement
Sponsor
Spine Centre of Southern Denmark
Enrollment
87
Locations
3
Primary Endpoint
The Conditioned pain modulation effect [changes in kPa]
Status
Completed
Last Updated
3 years ago

Overview

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)
Registry
clinicaltrials.gov
Start Date
May 10, 2021
End Date
March 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Spine Centre of Southern Denmark
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Pressure pain threshold(Baseline)

Study Sites (3)

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