Impact on Pain Sensitivity of Clinical Interaction

Pain Measurement Clinical Trial

— QSTROBOT  

Official title:

Impact on Pain Sensitivity of Clinical Interaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888026
• Other study ID #: QSTROBOT
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: December 2022
• Source: Spine Centre of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Pain Measurement

Intervention

Device:
• Quantitative 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

Locations

Country	Name	City	State
Denmark	Spine Centre of Southern Denmark	Middelfart
Denmark	The Spine Center of Southern Denmark	Middelfart
Denmark	Department of Physocolgy	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Spine Centre of Southern Denmark	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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