Low Back PainPOINTPMNCT02774694
Prediction of Outcome of Interventional Pain Management
An observational study of Low Back Pain and Neck Pain, run by Benno Rehberg-Klug at 1 site in Switzerland.
Trial summary
Interventional pain management for back and neck pain is widely used, but the indications and relative merits of these techniques rest subject to discussion. This study aims to identify prognostic criteria for patients who might specifically benefit from interventional pain management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Neck Pain, Chronic Pain
- What is being tested?
- nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2026to Sep 2027
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Included will be patients treated by the interventional pain management team of the department of anaesthesiology of the Geneva University Hospitals HUG
Who may be able to join
- patients with chronic low back or neck pain (duration >3 months)
- scheduled for the following interventions: epidural injection, facet block, medial branch block, facet radiofrequency denervation, spinal cord stimulator implantation
Who cannot join
- inability to understand the patient information or the study questionnaires
- patients <18 years old
- patients with implanted pacemakers or defibrillators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of the Nociceptive Flexion Reflex Threshold to Predict Outcome After Interventional Pain Management Procedures in Patients With Chronic Back and Neck Pain. A Study of Diagnostic Accuracy
Interventional pain management for back and neck pain is widely used, but the indications and relative merits of these techniques rest subject to discussion. This study aims to identify prognostic criteria for patients who might specifically benefit from interventional pain management. Specifically, the nociceptive reflex threshold will be investigated, which is a measure of central sensibilisation and thus a potentially important prognostic factor.
Read the detailed description
Interventional pain management is resource-intensive and carries non-negligible risks. Not all patients profit equally from such procedures. For those who do not benefit, the risk of potential complications is futile, and the resources are wasted. Therefore, a possibility to distinguish responding patients from non-responders would be important.
Central pain sensitization has been related to poor outcome, and electrical pain and reflex thresholds are a good measure of pain hypersensitivity at least in chronic low back pain. Especially the nociceptive flexion reflex (NFR) threshold has been identified to correlate well with central pain hypersensibility. Successful interventional pain treatment has been shown to reverse central hypersensibility as measured by the NFR threshold.
NFR threshold, in contrast to pain threshold, seems to be a measure independent of psychological factors. Thus the NFR threshold could give information independent of psychological factors in order to predict poor outcome of interventional pain management procedures.
The study will be a prospective observational trial of diagnostic accuracy.
- Conditions
- Low Back Pain, Neck Pain, Chronic Pain
- Being tested
- nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)
- Keywords
- nociceptive flexion reflex, interventional pain management
- Medical subject headings
- Low Back Pain, Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)Device
Also called R3 reflex
measurement of the NFR threshold using the "Paintracker" device
| Study group | Role | What they receive |
|---|---|---|
| observational cohort | patients undergoing interventional pain management procedures Receives: Device: nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC-AUC for incidence of pain reduction>30% at 1 week
Primary study outcome is the diagnostic accuracy of the NFR threshold, measured as area under the "receiver operating characteristic ROC" curve, for the following main pain management outcome:
"pain reduction of 30% one week after the interventional procedure
Measured: 1 week
Secondary outcomes (8)
ROC-AUC for incidence of pain reduction>30% at 1 month
Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction>30% at 1 month
Measured: 1 month
ROC-AUC for incidence of pain reduction>30% at 3 months
Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction>30% at 3 months
Measured: 3 months
ROC-AUC for incidence of pain reduction>30% at 6 months
Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction>30% at 6 months
Measured: 6 months
ROC-AUC for physical functioning at 1 week
Measured: 1 week
ROC-AUC for emotional functioning at 1 week
Measured: 1 week
ROC-AUC for patient rating of improvement and satisfaction at 1 week
Measured: 1 week
adverse events of interventional pain management
Measured: 1 week
patient disposition at 1 week, 1,3, and 6 months
The presence or unexcused absence of the patient at each consultation visit is noted
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJun 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Why it stopped: research team not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benno Rehberg-Klug
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benno Rehberg-Klug, University Hospital, Geneva
- Investigators
- Benno Rehberg-Klug, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774694
- Sponsor's protocol ID
- 15-072
- Acronym
- POINTPM
- Status last verified
- May 2026
- First submitted
- 2 Dec 2015
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Nociceptive Flexion Reflex Threshold to Predict Outcome After Interventional Pain Management Procedures in Patients With Chronic Back and Neck Pain. A Study of Diagnostic Accuracy
- ClinicalTrials.gov ID
- NCT02774694
- Acronym / sponsor ID
- POINTPM / 15-072
- Conditions
- Low Back Pain, Neck Pain, Chronic Pain
- Keywords
- nociceptive flexion reflex, interventional pain management
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: research team not available
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Benno Rehberg-KlugUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 May 2016 (estimated)
- 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.
Interventional pain management for back and neck pain is widely used, but the indications and relative merits of these techniques rest subject to discussion. This study aims to identify prognostic criteria for patients who might specifically benefit from interventional pain management. Specifically, the nociceptive reflex threshold will be investigated, which is a measure of central sensibilisation and thus a potentially important prognostic factor.
Detailed description
Interventional pain management is resource-intensive and carries non-negligible risks. Not all patients profit equally from such procedures. For those who do not benefit, the risk of potential complications is futile, and the resources are wasted. Therefore, a possibility to distinguish responding patients from non-responders would be important.
Central pain sensitization has been related to poor outcome, and electrical pain and reflex thresholds are a good measure of pain hypersensitivity at least in chronic low back pain. Especially the nociceptive flexion reflex (NFR) threshold has been identified to correlate well with central pain hypersensibility. Successful interventional pain treatment has been shown to reverse central hypersensibility as measured by the NFR threshold.
NFR threshold, in contrast to pain threshold, seems to be a measure independent of psychological factors. Thus the NFR threshold could give information independent of psychological factors in order to predict poor outcome of interventional pain management procedures.
The study will be a prospective observational trial of diagnostic accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational cohort | – | Device: nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)patients undergoing interventional pain management procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included will be patients treated by the interventional pain management team of the department of anaesthesiology of the Geneva University Hospitals HUG
Key inclusion criteria (2 listed)
- patients with chronic low back or neck pain (duration >3 months)
- scheduled for the following interventions: epidural injection, facet block, medial branch block, facet radiofrequency denervation, spinal cord stimulator implantation
Key exclusion criteria (3 listed)
- inability to understand the patient information or the study questionnaires
- patients <18 years old
- patients with implanted pacemakers or defibrillators
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 |
|---|---|---|
| nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)Also: R3 reflexmeasurement of the NFR threshold using the "Paintracker" device | Device | observational cohort |
Primary outcome
ROC-AUC for incidence of pain reduction>30% at 1 week
Time frame: 1 week
Primary study outcome is the diagnostic accuracy of the NFR threshold, measured as area under the "receiver operating characteristic ROC" curve, for the following main pain management outcome: "pain reduction of 30% one week after the interventional procedure
8 secondary outcomes
ROC-AUC for incidence of pain reduction>30% at 1 month
Time frame: 1 month
ROC-AUC for incidence of pain reduction>30% at 3 months
Time frame: 3 months
ROC-AUC for incidence of pain reduction>30% at 6 months
Time frame: 6 months
ROC-AUC for physical functioning at 1 week
Time frame: 1 week
ROC-AUC for emotional functioning at 1 week
Time frame: 1 week
ROC-AUC for patient rating of improvement and satisfaction at 1 week
Time frame: 1 week
adverse events of interventional pain management
Time frame: 1 week
patient disposition at 1 week, 1,3, and 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Benno Rehberg-Klug, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Neck Pain, run by Benno Rehberg-Klug at 1 site in Switzerland.
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 2 inclusion and 3 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: paused, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
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?
ROC-AUC for incidence of pain reduction>30% at 1 week (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.