Degenerative Disc DiseasePOADOSpreNCT04934917
Brain Imaging of Pain-Related Processing and Structural Properties in Disc Degenerative Disease
An observational study of Degenerative Disc Disease, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
In this study, we apply brain MR imaging techniques at 3 Tesla to assess pain-relevant processing in patients with disc degenerative disease (DDD) scheduled for back surgery and age- and gender-matched controls without back pain. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 2 sitesSweden
- Study dates
- 28 Aug 2019to 1 Jul 2021
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients will be recruited through clinical collaborators (Stockholm Spine Center, Rygg Kirurgisk Centrum); HC will be recruited via online advertisement on the institution's website
Who may be able to join
- 30-60 year
- Right-handed
- DDD patients: Radiologically verified DDD and DDD pain as their main pain complaint
Who cannot join
- previous spine surgery
- significant pain problems due to other causes and/or other chronic pain syndromes
- inflammatory rheumatic diseases
- neurological/psychiatric disorders
- severe cardiovascular disease
- substance abuse
- BMI>40
- Contraindication to MRI
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Institute
Stockholm, 171 77
Karolinska Insitutet
Stockholm
About this study
In this study, we apply brain MR imaging techniques at 3 Tesla to assess pain-relevant processing in patients with disc degenerative disease (DDD) scheduled for back surgery and age- and gender-matched controls without back pain. Data collection pre-surgery is performed over two days: On the first day, all participants undergo a battery of questionnaires relevant for individuals with chronic pain and pain sensitivity testing, including temporal summation and pressure pain thresholds. On the second day, participants undergo a MRI protocol, which includes functional MRI (fMRI) and diffusion tensor imaging to assess microstructural properties and structural connectivity. During fMRI, an experimental pressure pain paradigm is performed at the calf i.e. a location not connected to patients' chronic pain condition. Instead, the experimental pain paradigm serves as a condition to test processing of noxious stimulation unrelated to patients' experienced chronic pain. The noxious input pressure is individually calibrated to 50 on a 0-100 VAS scale to ensure that individual pain perceptions, despite different pressure intensities, are comparable across participants. The sensory stimulation will consist of a low standardized pressure intensity (150kPa). In an additional fMRI paradigm, participants do not receive stimulation but are instructed to continuously rate fluctuating spontaneous ongoing back pain (DDD) or perceived unpleasantness (controls).
This project aims at investigating measures of brain architecture, neural response connected with evoked pain, connectivity (structural and functional) and pain-relevant psychometrics and questionnaire data in disc degenerative disease patients scheduled for back surgery. Specifically, MRI is performed to test whether i) patients display differences in properties of the mesolimbic circuit compared to healthy individuals and ii) behavioural as well as clinical characteristics related to the acquired MRI markers. This study is intended to serve as a baseline in a longitudinal project testing associations with between findings at baseline and following surgery (fusion/disc implants).
- Conditions
- Degenerative Disc Disease
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Magnetic Resonance Imaging. Pain testing: Temporal summation, Pain thresholds. Assessment of symptoms: Questionnaires. All interventions are made at baseline only (1 time/subject).
| Study group | Role | What they receive |
|---|---|---|
| Patients with disc degenerative disease (DDD) | Patients suffering from disc degenerative disease, age 30-60 years that are on the waiting list for surgery (fusion/disc implants) at Stockholm Spine Center, Stockholm, Sweden. Receives: Device: Magnetic Resonance Imaging | |
| Healthy controls (HC) | Healthy controls matched according to age and sex, no chronic pain conditions. Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging (rsfMRI)
Analysis of network connectivity during resting state
Measured: Baseline
Functional magnetic resonance imaging (BOLD)
cerebral pain related activation following evoked pressure pain stimuli
Measured: Baseline
Diffuse Tensor Imaging
White matter microstructure (e.g. structural connectivity)
Measured: Baseline
Pressure pain thresholds
Pressure allometry (mmHg)
Measured: Baseline
Temporal summation
Pain ratings during repeated pressure stimuli, ratings from 0-100, with 100 being worst pain imaginable
Measured: Baseline
Secondary outcomes (8)
Pain intensity ratings
Visual analogue scale, 0-100 mm, 100 mm, worst possible pain
Measured: Baseline
Oswestry Disability Index
0-100, 0=no disability, 100= worst disability
Measured: Baseline
Fibromyalgia criteria-2016 revision (American College of Rheumatology)
Calculation of FMness score, 0-31, 0 = no symptoms, 31 = worst symptoms
Measured: Baseline
Multidimensional Fatigue Inventory
Total fatigue score, range 20-100, 100 = worst fatigue
Measured: Baseline
Pain catastrophizing scale
Total score 0-52, high values more catastrophizing
Measured: Baseline
Beck Depression Inventory
Scores 0-63, with 63 highest depression
Measured: Baseline
State-Trait Anxiety Inventory
Scores 20-80 for state and 20-80 for trait anxiety, higher levels indicate more anxiety
Measured: Baseline
EuroQual-5D
Scale ranging from -0.224 to 1, with 1 being highest possible health related quality of life
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start28 Aug 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Covid related problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Kosek, Karolinska Institutet
- Investigators
- Eva Kosek, Prof, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934917
- Sponsor's protocol ID
- 2019-01142_1pre
- Other IDs
- 2019
- Acronym
- POADOSpre
- Status last verified
- Sep 2022
- First submitted
- 25 May 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging of Pain-Related Processing and Structural Properties in Disc Degenerative Disease
- ClinicalTrials.gov ID
- NCT04934917
- Acronym / sponsor ID
- POADOSpre / 2019-01142_1pre
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid related problems
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 22 Jun 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.
In this study, we apply brain MR imaging techniques at 3 Tesla to assess pain-relevant processing in patients with disc degenerative disease (DDD) scheduled for back surgery and age- and gender-matched controls without back pain. Data collection pre-surgery is performed over two days: On the first day, all participants undergo a battery of questionnaires relevant for individuals with chronic pain and pain sensitivity testing, including temporal summation and pressure pain thresholds. On the second day, participants undergo a MRI protocol, which includes functional MRI (fMRI) and diffusion tensor imaging to assess microstructural properties and structural connectivity. During fMRI, an experimental pressure pain paradigm is performed at the calf i.e. a location not connected to patients' chronic pain condition. Instead, the experimental pain paradigm serves as a condition to test processing of noxious stimulation unrelated to patients' experienced chronic pain. The noxious input pressure is individually calibrated to 50 on a 0-100 VAS scale to ensure that individual pain perceptions, despite different pressure intensities, are comparable across participants. The sensory stimulation will consist of a low standardized pressure intensity (150kPa). In an additional fMRI paradigm, participants do not receive stimulation but are instructed to continuously rate fluctuating spontaneous ongoing back pain (DDD) or perceived unpleasantness (controls).
This project aims at investigating measures of brain architecture, neural response connected with evoked pain, connectivity (structural and functional) and pain-relevant psychometrics and questionnaire data in disc degenerative disease patients scheduled for back surgery. Specifically, MRI is performed to test whether i) patients display differences in properties of the mesolimbic circuit compared to healthy individuals and ii) behavioural as well as clinical characteristics related to the acquired MRI markers. This study is intended to serve as a baseline in a longitudinal project testing associations with between findings at baseline and following surgery (fusion/disc implants).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with disc degenerative disease (DDD) | – | Device: Magnetic Resonance ImagingPatients suffering from disc degenerative disease, age 30-60 years that are on the waiting list for surgery (fusion/disc implants) at Stockholm Spine Center, Stockholm, Sweden. |
| Healthy controls (HC) | – | Device: Magnetic Resonance ImagingHealthy controls matched according to age and sex, no chronic pain conditions. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be recruited through clinical collaborators (Stockholm Spine Center, Rygg Kirurgisk Centrum); HC will be recruited via online advertisement on the institution's website
Key inclusion criteria (3 listed)
- 30-60 year
- Right-handed
- DDD patients: Radiologically verified DDD and DDD pain as their main pain complaint
Key exclusion criteria (8 listed)
- previous spine surgery
- significant pain problems due to other causes and/or other chronic pain syndromes
- inflammatory rheumatic diseases
- neurological/psychiatric disorders
- severe cardiovascular disease
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 |
|---|---|---|
| Magnetic Resonance ImagingMagnetic Resonance Imaging. Pain testing: Temporal summation, Pain thresholds. Assessment of symptoms: Questionnaires. All interventions are made at baseline only (1 time/subject). | Device | Healthy controls (HC), Patients with disc degenerative disease (DDD) |
Primary outcome
Functional magnetic resonance imaging (rsfMRI)
Time frame: Baseline
Analysis of network connectivity during resting state
Functional magnetic resonance imaging (BOLD)
Time frame: Baseline
cerebral pain related activation following evoked pressure pain stimuli
Diffuse Tensor Imaging
Time frame: Baseline
White matter microstructure (e.g. structural connectivity)
Pressure pain thresholds
Time frame: Baseline
Pressure allometry (mmHg)
Temporal summation
Time frame: Baseline
Pain ratings during repeated pressure stimuli, ratings from 0-100, with 100 being worst pain imaginable
8 secondary outcomes
Pain intensity ratings
Time frame: Baseline
Oswestry Disability Index
Time frame: Baseline
Fibromyalgia criteria-2016 revision (American College of Rheumatology)
Time frame: Baseline
Multidimensional Fatigue Inventory
Time frame: Baseline
Pain catastrophizing scale
Time frame: Baseline
Beck Depression Inventory
Time frame: Baseline
State-Trait Anxiety Inventory
Time frame: Baseline
EuroQual-5D
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Covid related problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Eva Kosek, Prof, MD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Karolinska Institutet at 2 sites in Sweden.
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 8 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: stopped early, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 was stopped early (reason given: Covid related problems). 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?
Functional magnetic resonance imaging (rsfMRI) (time frame: Baseline). The study lists 5 primary outcomes in all. 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 30 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.