Pain MeasurementQSTROBOTNCT04888026
Impact on Pain Sensitivity of Clinical Interaction
A study testing Quantitative sensory testing in people with Pain Measurement, run by Spine Centre of Southern Denmark at 3 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Quantitative sensory testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 3 sitesDenmark
- Study dates
- 10 May 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary complaint of low back pain
- No pain for healthy controls
- No serious psychological or somatic disorders potentially interfering with the QST
Who cannot join
- Incomplete QST data
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Spine Centre of Southern Denmark
Middelfart, 5500
The Spine Center of Southern Denmark
Middelfart, 5500
Department of Physocolgy
Odense, 5230
About this study
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)
- Conditions
- Pain Measurement
- Being tested
- Quantitative sensory testing
- Keywords
- Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testingDevice
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 group | Role | What they receive |
|---|---|---|
| Automated QST procedure | Experimental | 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 Receives: Device: Quantitative sensory testing |
| Manual QST procedure | Active comparator | 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. Receives: Device: Quantitative sensory testing |
| Semi-automated QST procedure | Active comparator | 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. Receives: Device: Quantitative sensory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Baseline
Secondary outcomes (1)
Pressure pain threshold
Between-group differences in pressure pain threshold [range 0-1000 kPa] as measured before the cold pressor test
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start10 May 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Søren Neill, PhD, Principal investigator, Director of research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888026
- Sponsor's protocol ID
- QSTROBOT
- Acronym
- QSTROBOT
- Status last verified
- Dec 2022
- First submitted
- 22 Mar 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available upon reasonable request after the pre-planned analysis are performed
Publications
Nim CG, Ravn SL, Andersen TE, Engelsholm E, Hestbech F, Hvidkaer IS, Traidl AN, O'Neill S. No effect of social interaction on experimental pain sensitivity: a randomized experimental study. Pain. 2023 Sep 1;164(9):2112-2121. doi: 10.1097/j.pain.0000000000002913. Epub 2023 Apr 13.
PubMed 37058414
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Pain Sensitivity of Clinical Interaction
- ClinicalTrials.gov ID
- NCT04888026
- Acronym / sponsor ID
- QSTROBOT / QSTROBOT
- Conditions
- Pain Measurement
- Keywords
- Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 10 May 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Automated QST procedure | Experimental | Device: Quantitative sensory testingThe 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 |
| Manual QST procedure | Active comparator | Device: Quantitative sensory testingThe 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. |
| Semi-automated QST procedure | Active comparator | Device: Quantitative sensory testingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary complaint of low back pain
- No pain for healthy controls
- No serious psychological or somatic disorders potentially interfering with the QST
Key exclusion criteria (1 listed)
- Incomplete QST data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative sensory testingThe 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 | Device | Automated QST procedure, Manual QST procedure, Semi-automated QST procedure |
Primary outcome
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].
1 secondary outcome
Pressure pain threshold
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 37058414Nim CG, Ravn SL, Andersen TE, Engelsholm E, Hestbech F, Hvidkaer IS, Traidl AN, O'Neill S. No effect of social interaction on experimental pain sensitivity: a randomized experimental study. Pain. 2023 Sep 1;164(9):2112-2121. doi: 10.1097/j.pain.0000000000002913. Epub 2023 Apr 13.
- Individual participant dataSharing planned: No. Data is available upon reasonable request after the pre-planned analysis are performed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Neill, PhD principal investigator
Director of research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative sensory testing in people with Pain Measurement, run by Spine Centre of Southern Denmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Conditioned pain modulation effect [changes in kPa] (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.