Low Back PainNCT04323293
Pain Modulation - Experimental Assessments Using Different Modalities
A study testing Cold Water Bath and Neutral Water Bath in people with Low Back Pain and Compare Pain Modulation Assessments in Pain-free Cohorts, run by Schweinhardt Petra at 1 site in Switzerland.
Trial summary
The goal of this study is to investigate how different painful stimuli are processed and modulated in the nervous system. In various pain conditions, including low back pain, often no specific source can be identified as the cause of the pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Compare Pain Modulation Assessments in Pain-free Cohorts
- What is being tested?
- Cold Water Bath and Neutral Water Bath
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 705 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2019to 31 May 2025
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- German or English proficiency
- Informed consent
- primary pain complaint localized between the 12th rib and the gluteal fold
- low back pain for more than one week
- low back pain clinically not attributable to "red flags" (including infection, trauma, fractures, inflammatory)
Who cannot join
- unable to give informed consent (e.g. due to language problems)
- any neurological condition
- any major medical or psychiatric condition (e.g. severe heart disease, diabetes, autoimmune disorders, major depressive disorder), any chronic pain condition other than low back pain
- pregnancy
- Radiating pain below knee level (radicular pain)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist University Hospital
Zurich, 8008
Petra Schweinhardt, PhD, +41 44 510 73 81, petra.schweinhardt@balgrist.ch
Luana Nyirö, DCM, +41 44 386 57 28, luana.nyiroe@balgrist.ch
About this study
The goal of this study is to investigate how different painful stimuli are processed and modulated in the nervous system. In various pain conditions, including low back pain, often no specific source can be identified as the cause of the pain. Scientific findings point towards a possible involvement of sensitization processes in the central nervous system (spinal cord and brain) that can contribute to the development and persistence of chronic pain. There is a need for reliable and well established experimental methods to better investigate and understand these processes. Frequently used methods comprise the application of thermal, mechanical or electrical stimulations. These modalities are processed in different parts of the nervous system, each allowing its own conclusions. This can be an advantage, but it also poses a challenge regarding comparability and generalizability of obtained results.
This study aims to apply and compare various experimental methods in people without and people with low back pain and shed light on the methodological differences. In the future, this could enable better identification and characterization of sensitization processes in the nervous system and build the basis for individually adapted, mechanism-targeted treatments with better patient outcomes.
- Being tested
- Cold Water Bath, Neutral Water Bath
- Keywords
- low back pain, temporal summation of pain, conditioned pain modulation
- 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.
Cold Water BathOther
immersion of the hand for 2-5min in 2-10°C water
Neutral Water BathOther
immersion of the hand for 2-5min in 32±2°C water
| Study group | Role | What they receive |
|---|---|---|
| CPM - Cold Water Bath | Experimental | Not described Receives: Other: Cold Water Bath |
| CPM - SHAM | Sham comparator | Not described Receives: Other: Neutral Water Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal Summation of Pain (TSP)
TSP is measured as the change in perceived pain over time in response to repetitive noxious stimulation. In this study, a series of stimulations will be applied using different modalities (pressure, superficial mechanical, heat or electrical stimuli). Participants will be asked to report the perceived pain in response to the stimulations on an 11-point numerical rating scale (0: no pain, 10: most intense pain) or a visual analogue scale (VAS). VAS will be anchored with 0 ("no sensation"), 40 ("just painful," defined as the pain threshold), and 100 ("most intense pain tolerable"). Reflex parameters (thresholds in milliampere (mA); amplitude in μV) will be recorded at start and end of the series. Differences in read-outs (pain ratings, reflex thresholds or reflex amplitudes) at the start of the series compared to the end of the series or the slope of the pain ratings over the series will serve as TSP measures. Greater differences (end-start) or steeper slopes represent a greater TSP.
Measured: 1-4 weeks
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 (numerical rating scale or VAS, anchors see TSP outcome); perception thresholds (in kg for pressure, millinewton for superficial mechanical, °C for heat and mA for electrical stimuli); pain thresholds; reflex parameters (thresholds in mA and/or amplitudes).
Measured: 1-4 weeks
CPM effect on TSP
Changes in TSP in response to the intervention (conditioning stimulus: cold water bath or SHAM).
Measured: 1-4 weeks
Secondary outcomes (11)
Pressure sensory and pain sensitivity
Pressure sensitivity will be assessed by for example perception and pain thresholds measured in kg/cm^2. Low thresholds reflect greater sensitivity.
Measured: 1-4 weeks
Mechanical sensory and pain sensitivity
Mechanical (superficial) sensitivity will be assessed by for example perception and pain thresholds measured in millinewton. Low thresholds reflect greater sensitivity.
Measured: 1-4 weeks
Heat sensory and pain sensitivity
Heat sensitivity will be assessed by for example perception and pain thresholds measured in °C. Low thresholds reflect greater sensitivity.
Measured: 1-4 weeks
Electrical sensory and pain sensitivity
Electrical sensitivity will be assessed by for example perception, pain and reflex thresholds measured in milliampere. Low thresholds reflect greater sensitivity.
Measured: 1-4 weeks
Pain Catastrophizing
Pain catastrophizing will be assessed using questionnaires as for example the Pain Catastrophizing Scale (0-52; higher score meaning more catastrophizing).
Measured: 1-4 weeks
Fear of pain
Fear of pain will be assessed using questionnaires as for example the Fear Avoidance Belief Questionnaire (0-96) or the Tampa Scale of Kinesiophobia (17-69; higher scores meaning greater fear of pain).
Measured: 1-4 weeks
Anxiety
Anxiety will be assessed using questionnaires as for example the Spielberger's State and Trait Anxiety Inventory (20-80; higher scores meaning greater anxiety).
depression (e.g., Becks Depression Inventory(0-63); higher scores meaning greater level of depression).
Measured: 1-4 weeks
Depression
Depression will be assessed using questionnaires as for example the Becks Depression Inventory (0-63; higher scores meaning greater level of depression).
Measured: 1-4 weeks
Pain duration
Low back pain patients will be asked to indicate the duration of their clinical pain in months/years.
Measured: 1-4 weeks
Spatial 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: 1-4 weeks
Somatic symptoms
Additional questionnaires complementing the psychological construct "pain catastrophizing" are implemented in selected subprojects of the study, e.g., the "Somatic Symptom Scale - 8" (higher score meaning higher somatic symptom burden).
Measured: 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 May 2019
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants (pain-free controls or patients with low back pain) will undergo either only one intervention (cold water bath) or two interventions in randomized order (cold water bath, water bath of neutral temperature as SHAM condition).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 705 participants (estimated)
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, PhD, Principal investigator, Integrative Spinal Research, Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323293
- Sponsor's protocol ID
- Pain modulation assessments
- Status last verified
- Apr 2023
- First submitted
- 11 Mar 2020
- Last updated
- 14 Apr 2023
- 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 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Modulation - Experimental Assessments Using Different Modalities
- ClinicalTrials.gov ID
- NCT04323293
- Acronym / sponsor ID
- Pain modulation assessments
- Keywords
- low back pain, temporal summation of pain, conditioned pain modulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 705 participants (estimated)
- Lead sponsor
- Schweinhardt PetraUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 26 Mar 2020 (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 goal of this study is to investigate how different painful stimuli are processed and modulated in the nervous system. In various pain conditions, including low back pain, often no specific source can be identified as the cause of the pain. Scientific findings point towards a possible involvement of sensitization processes in the central nervous system (spinal cord and brain) that can contribute to the development and persistence of chronic pain. There is a need for reliable and well established experimental methods to better investigate and understand these processes. Frequently used methods comprise the application of thermal, mechanical or electrical stimulations. These modalities are processed in different parts of the nervous system, each allowing its own conclusions. This can be an advantage, but it also poses a challenge regarding comparability and generalizability of obtained results.
This study aims to apply and compare various experimental methods in people without and people with low back pain and shed light on the methodological differences. In the future, this could enable better identification and characterization of sensitization processes in the nervous system and build the basis for individually adapted, mechanism-targeted treatments with better patient outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants (pain-free controls or patients with low back pain) will undergo either only one intervention (cold water bath) or two interventions in randomized order (cold water bath, water bath of neutral temperature as SHAM condition).
| Arm | Type | Receives |
|---|---|---|
| CPM - Cold Water Bath | Experimental | Other: Cold Water Bath |
| CPM - SHAM | Sham comparator | Other: Neutral Water Bath |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- German or English proficiency
- Informed consent
- primary pain complaint localized between the 12th rib and the gluteal fold
- low back pain for more than one week
- low back pain clinically not attributable to "red flags" (including infection, trauma, fractures, inflammatory)
Key exclusion criteria (5 listed)
- unable to give informed consent (e.g. due to language problems)
- any neurological condition
- any major medical or psychiatric condition (e.g. severe heart disease, diabetes, autoimmune disorders, major depressive disorder), any chronic pain condition other than low back pain
- pregnancy
- Radiating pain below knee level (radicular pain)
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 |
|---|---|---|
| Cold Water Bathimmersion of the hand for 2-5min in 2-10°C water | Other | CPM - Cold Water Bath |
| Neutral Water Bathimmersion of the hand for 2-5min in 32±2°C water | Other | CPM - SHAM |
Primary outcome
Temporal Summation of Pain (TSP)
Time frame: 1-4 weeks
TSP is measured as the change in perceived pain over time in response to repetitive noxious stimulation. In this study, a series of stimulations will be applied using different modalities (pressure, superficial mechanical, heat or electrical stimuli). Participants will be asked to report the perceived pain in response to the stimulations on an 11-point numerical rating scale (0: no pain, 10: most intense pain) or a visual analogue scale (VAS). VAS will be anchored with 0 ("no sensation"), 40 ("just painful," defined as the pain threshold), and 100 ("most intense pain tolerable"). Reflex parameters (thresholds in milliampere (mA); amplitude in μV) will be recorded at start and end of the series. Differences in read-outs (pain ratings, reflex thresholds or reflex amplitudes) at the start of the series compared to the end of the series or the slope of the pain ratings over the series will serve as TSP measures. Greater differences (end-start) or steeper slopes represent a greater TSP.
Conditioned Pain Modulation (CPM)
Time frame: 1-4 weeks
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 (numerical rating scale or VAS, anchors see TSP outcome); perception thresholds (in kg for pressure, millinewton for superficial mechanical, °C for heat and mA for electrical stimuli); pain thresholds; reflex parameters (thresholds in mA and/or amplitudes).
CPM effect on TSP
Time frame: 1-4 weeks
Changes in TSP in response to the intervention (conditioning stimulus: cold water bath or SHAM).
11 secondary outcomes
Pressure sensory and pain sensitivity
Time frame: 1-4 weeks
Mechanical sensory and pain sensitivity
Time frame: 1-4 weeks
Heat sensory and pain sensitivity
Time frame: 1-4 weeks
Electrical sensory and pain sensitivity
Time frame: 1-4 weeks
Pain Catastrophizing
Time frame: 1-4 weeks
Fear of pain
Time frame: 1-4 weeks
Anxiety
Time frame: 1-4 weeks
Depression
Time frame: 1-4 weeks
Pain duration
Time frame: 1-4 weeks
Spatial pain extent
Time frame: 1-4 weeks
Somatic symptoms
Time frame: 1-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
Related trials for Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
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, PhD principal investigator
Integrative Spinal Research, Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Water Bath and Neutral Water Bath in people with Low Back Pain and Compare Pain Modulation Assessments in Pain-free Cohorts, 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 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
Contact Petra Schweinhardt, PhD (+41 44 510 73 81, petra.schweinhardt@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal Summation of Pain (TSP) (time frame: 1-4 weeks). The study lists 3 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 14 Apr 2023.