- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06412484
State vs. Trait Alterations in Low Back Pain
Low Back Pain - Disentangling Trait-Like and State-Like Alterations
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Petra Schweinhardt
- Phone Number: +41 44 386 57 24
- Email: petra.schweinhardt@balgrist.ch
Study Contact Backup
- Name: Beatriz Chozas Barrientos
- Phone Number: +41 77 809 72 12
- Email: beatriz.chozasbarrientos@balgrist.ch
Study Locations
-
-
-
Zürich, Switzerland, 8008
- Recruiting
- Balgrist Campus
-
Contact:
- Petra Schweinhardt, MD, PhD
- Phone Number: +41445107381
- Email: petra.schweinhardt@balgrist.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria (applicable to both groups):
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
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.
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.
|
Healthy Controls (HCs)
HCs will undergo one single visit, equivalent to patients' "pain-free" visit.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
1 - 6 months
|
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. |
1 - 6 months
|
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. |
1 - 6 months
|
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. |
1 - 6 months
|
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. |
1 - 6 months
|
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. |
1 - 6 months
|
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.
|
1 - 6 months
|
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).
|
1 - 6 months
|
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.
|
1 - 6 months
|
Lumbar Magnetic Resonance Imaging
Time Frame: 1 - 6 months
|
Structural resonance image of lumbar spine section acquired using a 3T Siemens scanner.
|
1 - 6 months
|
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.
|
1 - 6 months
|
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).
|
1 - 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety and Depression
Time Frame: 1 - 6 months
|
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.
|
1 - 6 months
|
Pain Catastrophizing
Time Frame: 1 - 6 months
|
Pain catastrophizing will be assessed using questionnaires as for example the Pain Catastrophizing Scale (0-52; higher score meaning more catastrophizing).
|
1 - 6 months
|
Pain Sensitivity
Time Frame: 1 - 6 months
|
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.
|
1 - 6 months
|
Pain Self Efficacy
Time Frame: 1 - 6 months
|
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.
|
1 - 6 months
|
Back Awareness
Time Frame: 1 - 6 months
|
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.
|
1 - 6 months
|
Central sensitization
Time Frame: 1 - 6 months
|
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. |
1 - 6 months
|
Widespread Pain Index (WPI)
Time Frame: 1 - 6 months
|
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:
|
1 - 6 months
|
Symptom Severity Scale (SSS)
Time Frame: 1 - 6 months
|
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:
|
1 - 6 months
|
Neuropathic Pain
Time Frame: 1 - 6 months
|
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.
|
1 - 6 months
|
Disability
Time Frame: 1 - 6 months
|
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.
|
1 - 6 months
|
Pain Extent
Time Frame: 1 - 6 months
|
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.
|
1 - 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Petra Schweinhardt, University of Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRPP Renewal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on Pain Free Session
-
University of AlcalaCompleted
-
Stanford UniversityThe Marfan FoundationActive, not recruitingChronic Pain | Marfan Syndrome | Vascular Ehlers-Danlos Syndrome | Loeys-Dietz SyndromeUnited States
-
University of FloridaCompletedHealthy | Musculoskeletal PainUnited States
-
The Cleveland ClinicCompletedDepression | Anxiety | Psychological StressUnited States
-
Talita Cumi Ltd.Not yet recruiting
-
University of Central FloridaCompleted
-
Liverpool University Hospitals NHS Foundation TrustNot yet recruiting
-
Stanford UniversityThe Cleveland Clinic; SCAN Health PlanNot yet recruitingChronic PainUnited States
-
University of Central LancashireRecruitingIntermittent ClaudicationUnited Kingdom