Low Back PainNCT06412484
State vs. Trait Alterations in Low Back Pain
An observational study of Low Back Pain, run by Schweinhardt Petra at 1 site in Switzerland.
Trial summary
The primary goal of this study is to investigate whether different alterations observed in patients with non-specific episodic low back pain (compared to healthy volunteers), detected using several assessments: psychophysical and neurophysiological testing, imaging, and blood sampling, are dependent or independent of… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pain Free Session, Low Back Pain Session (= clinically relevant pain) and Experimental Pain Session (= clinically irrelevant pain)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 105 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2023to 12 Feb 2026
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of people that suffer from non-specific low back pain, meaning that their pain cannot reliably be attributed to a specific pathology and radiographic abnormalities correlate poorly with patients' symptoms. Participants should suffer from chronic episodic low back pain, meaning that they have had back pain pain for at least more than 3 months, with recurrent fluctuating pain episodes.
Who may be able to join
- German or English proficiency
- Informed consent
- Low back pain for more than 3 months
- Low back pain clinically not attributable to "red flags" (e.g. infection, fractures, inflammation)
- Fluctuating course of pain (with on and off pain periods).
Who cannot join
- Inability to give informed consent / follow study instructions (e.g. due to language problems)
- Major medical or psychiatric condition. E.g. severe heart disease, diabetes, autoimmune disorders, rheumatic disorders, major depressive disorder, etc.
- Symptomatic radiculopathy, manifested through motor and/or sensory deficits / or signs of nerve root involvement on lumbar MRI.
- Back operation
- BMI > 30
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Back Pain - Disentangling Trait-Like and State-Like Alterations
The primary goal of this study is to investigate whether different alterations observed in patients with non-specific episodic low back pain (compared to healthy volunteers), detected using several assessments: psychophysical and neurophysiological testing, imaging, and blood sampling, are dependent or independent of the presence and type of pain experienced at the time of investigation.
Read the detailed description
The study consists of three visits (healthy volunteers will only have one pain-free visit), in which patients will be tested in a different "pain state" at each visit:
- Pain-free visit: will be carried out when the patients have no or little (Numerical Pain Rating Scale (NPRS) </= 2/10) clinical pain.
- Clinically relevant Low Back Pain visit: will be carried out with patients experiencing a low back pain episode with an intensity of 3/10 or more on the NPRS.
- Experimental pain / Clinically irrelevant pain visit: will be carried out with the application of a high concentration (8%) Qutenza® capsaicin patch at the arm.
Each of the visits will consist of psychophysical testing, neurophysiological assessement of sweat activity in response to pain, brain resting state magnetic resonance imaging and magnetic resonance spectroscopy. Additionally, and depending on the type of session, a lumbar spine magnetic resonance image (only pain-free session, as characterization) and a blood sample (only pain free and low back pain visit) will be performed.
- Conditions
- Low Back Pain
- Being tested
- Pain Free Session, Low Back Pain Session (= clinically relevant pain), Experimental Pain Session (= clinically irrelevant pain)
- Keywords
- Trait vs. State Alterations
- 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.
Pain Free SessionBehavioural
On a day in which participants don't have any pain or a pain ranging from 0-2 (on a numerical rating scale of 0-10), they will undergo all the study measures (see primary outcome measures for detail): clinical exam, QST, SSRs, CPM, rsMRI, lumbar MRI, MRS, and blood sample.
Low Back Pain Session (= clinically relevant pain)Behavioural
On a day in which patients have an ongoing typical low back pain episode of an intensity of 3 or more (on a numerical rating scale of 0-10), they will undergo all the study measures (see primary outcome measures for detail), except the lumbar MRI: clinical exam, QST, SSRs, CPM, rsMRI, MRS, and blood sample.
Experimental Pain Session (= clinically irrelevant pain)Behavioural
On a day in which participants don't have any pain or a pain ranging from 0-2 (on a numerical rating scale of 0-10), an experimental pain state will be induced using a high concentration (8%) Qutenza patch, containing capsaicin. All the study measures will be performed (see primary outcome measures for detail), except the lumbar MRI and blood sample: clinical exam, QST, SSRs, CPM, rsMRI, MRS.
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain (LBP) Patients | LBP patients will undergo three study visits, at moments at which their pain status is different: a) "pain-free", b) low back pain (clinically relevant), c) experimental pain (clinically irrelevant). Measures will be repeated in each visit, to understand the influence / relationship of pain state on possible mechanistic alterations observed in LBP compared to HCs. Receives: Behavioral: Pain Free Session; Behavioral: Low Back Pain Session (= clinically relevant pain); Behavioral: Experimental Pain Session (= clinically irrelevant pain) | |
| Healthy Controls (HCs) | HCs will undergo one single visit, equivalent to patients' "pain-free" visit. Receives: Behavioral: Pain Free Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Detection Threshold (MDT)
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area.
MDT will be assessed with Von Frey filaments applied to the skin (mN). Subject reports when tactile input is detected.
Measured: 1 - 6 months
Mechanical Pain Threshold (MPT)
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area.
MPT will be assessed with pin-pricks (mN) applied to the skin. Subject reports when the stimulus feels sharp or blunt.
Measured: 1 - 6 months
Mechanical Pain Sensitivity (MPS)
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area.
MPS will be assessed with pin-pricks and Q-tip, cotton swab, and brush applied to the skin. Subjects rate stimuli on scale of 0-100. In our protocol only 3 blocks.
Measured: 1 - 6 months
Wind-Up Ratio (WUR)
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area.
WUR will be assessed with a pin-prick, which is applied 10 times in 10 seconds. Subjects rate the series on scale of 0-100. In our protocol, only 3 series.
Measured: 1 - 6 months
Vibration Detection Threshold (VDT)
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area.
VDT will be assessed with a tuning fork applied to a bony prominence. Subject reports when the vibration can't be felt anymore.
Measured: 1 - 6 months
Pressure Pain Threshold (PPT):
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area.
PPT will be assessed with an algometer (kg), applied to a muscle. Subject reports when pressure becomes painful.
Measured: 1 - 6 months
Sympathetic Skin Responses (SSRs)
Neurophysiological assessement of sweat activity in response to pain will be recorded with cap electrodes located at the hand. Painful heat stimulation will be applied with a thermode of the Pathway Medoc System. A train of 15 heat stimuli, with an inter-stimulus interval of 13-17 seconds, will be applied. The thermode baseline temperature will be 42ºC and during the stimulation the temperature will quickly ramp up to 52 ºC. Subjects are asked to rate the perception of the stimulus using a pain scale of 0-100. This procedure will be done two times: one at the most painful area of the patients, and the corresponding body area in the matched healthy volunteer, and at the volar forearm as a control pain-free area. This readout is a proxy for sympathetic nervous system activity.
Measured: 1 - 6 months
Conditioned Pain Modulation (CPM)
CPM measures the modulation of a noxious test stimulus by another noxious conditioning stimulus applied at a remote body region. In this study, test stimuli of different modalities (pressure, superficial mechanical, heat or electrical stimuli) will be applied at different body regions before and after or before, during and after a cold water bath or neutral water bath (hand immersion) as conditioning stimulus. Changes in test stimuli read-outs (during-before or after-before) will serve as CPM measure. Negative changes represent inhibitory, positive changes facilitatory CPM effects. For all test stimuli read-outs, CPM effects will be expressed as percentage changes. Test stimuli read-outs include: pain ratings on a scale of 0: no pain, to 100: most intense pain; perception thresholds and pain thresholds (in kg for pressure).
Measured: 1 - 6 months
Brain resting state Magnetic Resonance Imaging (rsMRI)
Measure of the brain's spontaneous activity acquired during resting state using a 7T Siemens scanner.
Measured: 1 - 6 months
Lumbar Magnetic Resonance Imaging
Structural resonance image of lumbar spine section acquired using a 3T Siemens scanner.
Measured: 1 - 6 months
Brain Magnetic Resonance Spectroscopy (MRS)
Imaging method that allows the detection of concentration of certain metabolites in the brain. This data will be acquired using a 3T Phillips scanner.
Measured: 1 - 6 months
Blood Sample
Blood sample of approximately 14 ml will be drawn, in a total of 3 tubes: PAXGene blood RNA tube, Serum tube, and K2 EDTA tube. This will allow analysis of inflammatory molecules (i.e. cytokines) and cell concentrations (i.e. immune cells).
Measured: 1 - 6 months
Secondary outcomes (11)
Anxiety and Depression
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3), with 7 items for each subscale (anxiety and depression). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). Higher score means more anxiety or depression.
Measured: 1 - 6 months
Pain Catastrophizing
Pain catastrophizing will be assessed using questionnaires as for example the Pain Catastrophizing Scale (0-52; higher score meaning more catastrophizing).
Measured: 1 - 6 months
Pain Sensitivity
Pain sensitivity will be assessed using the Pain Sensitivity Questionnaire (PSQ). It consists of 17 items, with an answer range from 0 (not at all painful) to 10 (most severe pain imaginable). The maximum score is 170, where a higher score indicates a higher pain sensitivity.
Measured: 1 - 6 months
Pain Self Efficacy
Pain self efficacy will be assessed using the Pain Self Efficacy Questionnaire (PSEQ). It consists of 10 items, with an answer range from 0 (not at all confident) to 6 (completely confident). The maximum score is 60, where a higher score indicates a higher pain self efficacy / pain coping capacity.
Measured: 1 - 6 months
Back Awareness
Back awareness will be assessed using the Fremantle Back Awareness Questionnaire. It consists of 9 items, with an answer range from 0 (never) to 4 (always). The maximum score is 36, where a higher score indicates a decreased back awareness.
Measured: 1 - 6 months
Central sensitization
Central sensitization symptoms will be assessed using the Central Sensitization Inventory (CSI), which consists of two parts.
Part A: includes 25 questions assessing typical central sensitisation symptoms. Each answer is scored on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitisation.
Part B: determines if the patient has been diagnosed with certain central sensitivity disorder or related disorders, such as anxiety and depression.
Measured: 1 - 6 months
Widespread Pain Index (WPI)
Presence of fibromyalgia symptoms will be assessed using the WPI. In the WPI, patients report body areas in which they have had pain in the past week. Each marked area adds one point, to reach a total score of 19.
A patient would meet the criteria for fibromyalgia if:
- WPI score (Part 1) is 7 or higher and SSS score (see below) (Part 2a \& b) is 5 or higher OR
- WPI score (Part 1) is from 3 to 6 AND the SSS score (Part 2a \& b) is 9 or higher.
Measured: 1 - 6 months
Symptom Severity Scale (SSS)
Presence of fibromyalgia symptoms will be assessed using the SSS. SSS consists of two parts. In part A patients report the severity of fatigue, waking unrefreshed, and cognitive symptoms. Each question can be answered from 0-3, for a total of 9. The higher the score, the higher the severity of these symptoms. In part B, patients report other somatic symptoms that they have experienced in the past week, reaching a total score of 3. Parts A and B, have a total score of 12 put together.
A patient would meet the criteria for fibromyalgia if:
- WPI score (see above) (Part 1) is 7 or higher and SSS score (Part 2a \& b) is 5 or higher OR
- WPI score (Part 1) is from 3 to 6 AND the SSS score (Part 2a \& b) is 9 or higher.
Measured: 1 - 6 months
Neuropathic Pain
Neuropathic pain components will be assessed using PainDETECT, which consists of 9 items: 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics. A score of 19 or more (out of 38) indicates likely neuropathic pain.
Measured: 1 - 6 months
Disability
Patients' functional disability will be measured using the Oswestry Disability Index (ODI), which consists of 10 items addressing different aspects of life (i.e. walking, social life, hygiene, etc.). Each item, has a possible 5 point answer. A higher score indicates higher functional disability.
Measured: 1 - 6 months
Pain Extent
Low back pain patients will be asked to complete pain drawings indicating painful body regions. The painful body area will be calculated as percentage of the whole body area. Higher percentages represent more widespread pain.
Measured: 1 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Oct 2023
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schweinhardt Petra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Schweinhardt Petra, Balgrist University Hospital
- Investigators
- Petra Schweinhardt, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412484
- Sponsor's protocol ID
- CRPP Renewal
- Status last verified
- May 2024
- First submitted
- 22 Jan 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Back Pain - Disentangling Trait-Like and State-Like Alterations
- ClinicalTrials.gov ID
- NCT06412484
- Acronym / sponsor ID
- CRPP Renewal
- Conditions
- Low Back Pain
- Keywords
- Trait vs. State Alterations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Schweinhardt PetraUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 14 May 2024 (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.
The primary goal of this study is to investigate whether different alterations observed in patients with non-specific episodic low back pain (compared to healthy volunteers), detected using several assessments: psychophysical and neurophysiological testing, imaging, and blood sampling, are dependent or independent of the presence and type of pain experienced at the time of investigation.
Detailed description
The study consists of three visits (healthy volunteers will only have one pain-free visit), in which patients will be tested in a different "pain state" at each visit:
- Pain-free visit: will be carried out when the patients have no or little (Numerical Pain Rating Scale (NPRS) </= 2/10) clinical pain.
- Clinically relevant Low Back Pain visit: will be carried out with patients experiencing a low back pain episode with an intensity of 3/10 or more on the NPRS.
- Experimental pain / Clinically irrelevant pain visit: will be carried out with the application of a high concentration (8%) Qutenza® capsaicin patch at the arm.
Each of the visits will consist of psychophysical testing, neurophysiological assessement of sweat activity in response to pain, brain resting state magnetic resonance imaging and magnetic resonance spectroscopy. Additionally, and depending on the type of session, a lumbar spine magnetic resonance image (only pain-free session, as characterization) and a blood sample (only pain free and low back pain visit) will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain (LBP) Patients | – | Behavioral: Pain Free Session, Behavioral: Low Back Pain Session (= clinically relevant pain), Behavioral: Experimental Pain Session (= clinically irrelevant pain)LBP patients will undergo three study visits, at moments at which their pain status is different: a) "pain-free", b) low back pain (clinically relevant), c) experimental pain (clinically irrelevant). Measures will be repeated in each visit, to understand the influence / relationship of pain state on possible mechanistic alterations observed in LBP compared to HCs. |
| Healthy Controls (HCs) | – | Behavioral: Pain Free SessionHCs will undergo one single visit, equivalent to patients' "pain-free" visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of people that suffer from non-specific low back pain, meaning that their pain cannot reliably be attributed to a specific pathology and radiographic abnormalities correlate poorly with patients' symptoms. Participants should suffer from chronic episodic low back pain, meaning that they have had back pain pain for at least more than 3 months, with recurrent fluctuating pain episodes.
Key inclusion criteria (5 listed)
- German or English proficiency
- Informed consent
- Low back pain for more than 3 months
- Low back pain clinically not attributable to "red flags" (e.g. infection, fractures, inflammation)
- Fluctuating course of pain (with on and off pain periods).
Key exclusion criteria (6 listed)
- Inability to give informed consent / follow study instructions (e.g. due to language problems)
- Major medical or psychiatric condition. E.g. severe heart disease, diabetes, autoimmune disorders, rheumatic disorders, major depressive disorder, etc.
- Symptomatic radiculopathy, manifested through motor and/or sensory deficits / or signs of nerve root involvement on lumbar MRI.
- Back operation
- BMI > 30
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 |
|---|---|---|
| Pain Free SessionOn a day in which participants don't have any pain or a pain ranging from 0-2 (on a numerical rating scale of 0-10), they will undergo all the study measures (see primary outcome measures for detail): clinical exam, QST, SSRs, CPM, rsMRI, lumbar MRI, MRS, and blood sample. | Behavioural | Healthy Controls (HCs), Low Back Pain (LBP) Patients |
| Low Back Pain Session (= clinically relevant pain)On a day in which patients have an ongoing typical low back pain episode of an intensity of 3 or more (on a numerical rating scale of 0-10), they will undergo all the study measures (see primary outcome measures for detail), except the lumbar MRI: clinical exam, QST, SSRs, CPM, rsMRI, MRS, and blood sample. | Behavioural | Low Back Pain (LBP) Patients |
| Experimental Pain Session (= clinically irrelevant pain)On a day in which participants don't have any pain or a pain ranging from 0-2 (on a numerical rating scale of 0-10), an experimental pain state will be induced using a high concentration (8%) Qutenza patch, containing capsaicin. All the study measures will be performed (see primary outcome measures for detail), except the lumbar MRI and blood sample: clinical exam, QST, SSRs, CPM, rsMRI, MRS. | Behavioural | Low Back Pain (LBP) Patients |
Primary outcome
Mechanical Detection Threshold (MDT)
Time frame: 1 - 6 months
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. MDT will be assessed with Von Frey filaments applied to the skin (mN). Subject reports when tactile input is detected.
Mechanical Pain Threshold (MPT)
Time frame: 1 - 6 months
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. MPT will be assessed with pin-pricks (mN) applied to the skin. Subject reports when the stimulus feels sharp or blunt.
Mechanical Pain Sensitivity (MPS)
Time frame: 1 - 6 months
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. MPS will be assessed with pin-pricks and Q-tip, cotton swab, and brush applied to the skin. Subjects rate stimuli on scale of 0-100. In our protocol only 3 blocks.
Wind-Up Ratio (WUR)
Time frame: 1 - 6 months
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. WUR will be assessed with a pin-prick, which is applied 10 times in 10 seconds. Subjects rate the series on scale of 0-100. In our protocol, only 3 series.
Vibration Detection Threshold (VDT)
Time frame: 1 - 6 months
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. VDT will be assessed with a tuning fork applied to a bony prominence. Subject reports when the vibration can't be felt anymore.
Pressure Pain Threshold (PPT):
Time frame: 1 - 6 months
A reduced psychophysical QST battery will be performed in 3 body areas: most painful (MP), adjacent to MP, and a control area. PPT will be assessed with an algometer (kg), applied to a muscle. Subject reports when pressure becomes painful.
Sympathetic Skin Responses (SSRs)
Time frame: 1 - 6 months
Neurophysiological assessement of sweat activity in response to pain will be recorded with cap electrodes located at the hand. Painful heat stimulation will be applied with a thermode of the Pathway Medoc System. A train of 15 heat stimuli, with an inter-stimulus interval of 13-17 seconds, will be applied. The thermode baseline temperature will be 42ºC and during the stimulation the temperature will quickly ramp up to 52 ºC. Subjects are asked to rate the perception of the stimulus using a pain scale of 0-100. This procedure will be done two times: one at the most painful area of the patients, and the corresponding body area in the matched healthy volunteer, and at the volar forearm as a control pain-free area. This readout is a proxy for sympathetic nervous system activity.
Conditioned Pain Modulation (CPM)
Time frame: 1 - 6 months
CPM measures the modulation of a noxious test stimulus by another noxious conditioning stimulus applied at a remote body region. In this study, test stimuli of different modalities (pressure, superficial mechanical, heat or electrical stimuli) will be applied at different body regions before and after or before, during and after a cold water bath or neutral water bath (hand immersion) as conditioning stimulus. Changes in test stimuli read-outs (during-before or after-before) will serve as CPM measure. Negative changes represent inhibitory, positive changes facilitatory CPM effects. For all test stimuli read-outs, CPM effects will be expressed as percentage changes. Test stimuli read-outs include: pain ratings on a scale of 0: no pain, to 100: most intense pain; perception thresholds and pain thresholds (in kg for pressure).
Brain resting state Magnetic Resonance Imaging (rsMRI)
Time frame: 1 - 6 months
Measure of the brain's spontaneous activity acquired during resting state using a 7T Siemens scanner.
Lumbar Magnetic Resonance Imaging
Time frame: 1 - 6 months
Structural resonance image of lumbar spine section acquired using a 3T Siemens scanner.
Brain Magnetic Resonance Spectroscopy (MRS)
Time frame: 1 - 6 months
Imaging method that allows the detection of concentration of certain metabolites in the brain. This data will be acquired using a 3T Phillips scanner.
Blood Sample
Time frame: 1 - 6 months
Blood sample of approximately 14 ml will be drawn, in a total of 3 tubes: PAXGene blood RNA tube, Serum tube, and K2 EDTA tube. This will allow analysis of inflammatory molecules (i.e. cytokines) and cell concentrations (i.e. immune cells).
11 secondary outcomes
Anxiety and Depression
Time frame: 1 - 6 months
Pain Catastrophizing
Time frame: 1 - 6 months
Pain Sensitivity
Time frame: 1 - 6 months
Pain Self Efficacy
Time frame: 1 - 6 months
Back Awareness
Time frame: 1 - 6 months
Central sensitization
Time frame: 1 - 6 months
Widespread Pain Index (WPI)
Time frame: 1 - 6 months
Symptom Severity Scale (SSS)
Time frame: 1 - 6 months
Neuropathic Pain
Time frame: 1 - 6 months
Disability
Time frame: 1 - 6 months
Pain Extent
Time frame: 1 - 6 months
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 30 Jun 2026.
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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.
Petra Schweinhardt principal investigator
University of Zurich
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, run by Schweinhardt Petra 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 5 inclusion and 6 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 30 Jun 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?
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?
Mechanical Detection Threshold (MDT) (time frame: 1 - 6 months). The study lists 12 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 Jun 2026.