PainNCT03832036
The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation
A study testing Paraspinal Mapping and Quantitative Sensory Pain Test in people with Pain and Lumbar Disc Herniation, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
This study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Lumbar Disc Herniation, Back Pain
- What is being tested?
- Paraspinal Mapping and Quantitative Sensory Pain Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 1 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiologically diagnosed lumbar disc herniation.
- Low back pain with pain below the knee or anterior thigh pain in one or both legs.
- Dermatomal leg pain.
- Average pain intensity of 3 or more on a Numerical Rating Scale (0-10 NRS).
Who cannot join
- History of previous lumbar spine surgery.
- Surgery in general in the past 4 months.
- Current use of anticoagulants.
- Diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local muscle trauma, cancer metastases, fibromyalgia, neuropathy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Rheumatology and Spine Diseases, Frederiksberg Hospital.
Frederiksberg, 2000
About this study
Official title: The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients
This study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment.
The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.
Read the detailed description
150 patients will be included for the prospective cohort study. Patients will be recruited from the Region of Southern Denmark and Capital Region. Participants will undergo MRI scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two clinical tests. An 8-week follow-up will be made with patients completing a questionnaire. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.
- Conditions
- Pain, Lumbar Disc Herniation, Back Pain, Spinal Diseases, Surgery
- Being tested
- Paraspinal Mapping and Quantitative Sensory Pain Test
- Keywords
- Electromyography, Paraspinal Mapping, Quantitative clinical tests, Conditioned pain modulation, Temporal pain summation, Pain threshold, Pain tolerance
- Medical subject headings
- Pain, Intervertebral Disc Displacement, Back Pain, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraspinal Mapping and Quantitative Sensory Pain TestDiagnostic test
Participants will be tested at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lumbar disc herniation | Experimental | Not described Receives: Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing
Measured: 8 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Oct 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Frederiksberg University Hospital, Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark, Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Johanne B Filtenborg, M.Sc., Principal investigator, Spine Centre Southern DenmarkBerit Schiøttz-Christensen, MD, Study director, Spine Centre Southern DenmarkSøren O'Neill, DC, Study chair, Spine Centre Southern DenmarkKirstine Amris, MD, Study chair, The Parker Institute, Frederiksberg HospitalGilles Fournier, MD, DC, Study chair, Center for Rheumatology and Spine Diseases, Frederiksberg HospitalAndrew J Haig, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832036
- Sponsor's protocol ID
- 201170138
- Status last verified
- Jul 2025
- First submitted
- 26 Oct 2018
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients
- ClinicalTrials.gov ID
- NCT03832036
- Acronym / sponsor ID
- 201170138
- Conditions
- Pain, Lumbar Disc Herniation, Back Pain, Spinal Diseases, Surgery
- Keywords
- Electromyography, Paraspinal Mapping, Quantitative clinical tests, Conditioned pain modulation, Temporal pain summation, Pain threshold, Pain tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Collaborators
- Frederiksberg University Hospital, Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark, Odense University Hospital
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 6 Feb 2019 (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.
This study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment.
The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.
Detailed description
150 patients will be included for the prospective cohort study. Patients will be recruited from the Region of Southern Denmark and Capital Region. Participants will undergo MRI scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two clinical tests. An 8-week follow-up will be made with patients completing a questionnaire. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lumbar disc herniation | Experimental | Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical and radiologically diagnosed lumbar disc herniation.
- Low back pain with pain below the knee or anterior thigh pain in one or both legs.
- Dermatomal leg pain.
- Average pain intensity of 3 or more on a Numerical Rating Scale (0-10 NRS).
Key exclusion criteria (4 listed)
- History of previous lumbar spine surgery.
- Surgery in general in the past 4 months.
- Current use of anticoagulants.
- Diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local muscle trauma, cancer metastases, fibromyalgia, neuropathy.
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 |
|---|---|---|
| Paraspinal Mapping and Quantitative Sensory Pain TestParticipants will be tested at baseline. | Diagnostic test | Patients with lumbar disc herniation |
Primary outcome
The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing
Time frame: 8 week follow-up
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 8 Jul 2025.
- 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.
Johanne B Filtenborg, M.Sc. principal investigator
Spine Centre Southern Denmark
Berit Schiøttz-Christensen, MD study director
Spine Centre Southern Denmark
Søren O'Neill, DC study chair
Spine Centre Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraspinal Mapping and Quantitative Sensory Pain Test in people with Pain and Lumbar Disc Herniation, run by Spine Centre of Southern Denmark at 1 site 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 4 inclusion and 4 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 8 Jul 2025. 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 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 diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing (time frame: 8 week follow-up). 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 8 Jul 2025.