Pain MeasurementNCT00892411
Prognostic Value of Measures of the Central Hypersensitivity in Patients With Acute Low Back Pain
An observational study of Pain Measurement and Low Back Pain, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Background. Patients with chronic low back pain display hyperexcitability of the central nervous system (central hypersensitivity). Such hypersensitivity may occur in the acute phase and represent a risk factor for the development of chronic pain. Objective. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Measurement, Low Back Pain
- How many people
- 154 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Dec 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute low back pain referred from primary care.
Who may be able to join
- Acute low back pain < 6 weeks
- Age 18-80
Who cannot join
- History of chronic low back pain
- Radicular pain
- Pregnancy
- Breast feeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
Bern, 3010
About this study
Official title: Prognostic Value of Measures of Central Hypersensitivity in Patients With Low Back Pain
Background. Patients with chronic low back pain display hyperexcitability of the central nervous system (central hypersensitivity). Such hypersensitivity may occur in the acute phase and represent a risk factor for the development of chronic pain.
Objective. To determine the prognostic value of central hypersensitivity for the development of chronic low back pain.
Read more
Design. Prospective cohort study.
Setting. Primary care.
Patients. 140 individuals with acute low back pain and no history of chronic pain.
Outcomes. Primary prognostic variable will be the pain tolerance threshold at the second toe (the pressure intensity at which a further increase in pressure is deemed intolerable). Exploratory secondary prognostic variables are measures of mechanisms related to central hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs. widespread hypersensitivity; spinal cord modulation (electrophysiological measures of hypersensitivity and changes in receptive fields); modulation at brain level (descending modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be the occurrence of chronic low back pain at follow-up.
Main analysis. The investigators will use least square logistic regression models to determine the association of central hypersensitivity with prognosis.
Relevance. An understanding of the prognostic value of central hypersensitivity may allow an early stratification for treatment of individuals at risk of developing chronic low back pain. Subgroups of patients may be selected for clinical trials on novel pharmacological approaches for the prevention and treatment of central hypersensitivity.
Read the detailed description
Background
Prolonged afferent nociceptive input induces an increase in the excitability of central sensory neurons and plasticity changes that cause hyperexcitability of the central nervous system (central hypersensitivity. The hyperexcitable central nervous system amplifies the nociceptive signal, thereby producing an exaggerated pain response even in the presence of limited tissue damage.
Using quantitative sensory tests, central hypersensitivity has been detected in different chronic musculoskeletal pain syndromes. Patients with chronic low back pain display increased pain sensitivity and enlargement of the areas of referred pain after stimulation of tissues around and distant from the site of pain (i.e. the leg or the thumb), suggesting that widespread central hypersensitivity is associated with this condition. Functional reorganization of the cortex has been detected in different pain conditions, including low back pain. Using equal levels of sensory stimulation in patients and pain-free controls, patients with chronic low back pain showed more extensive patterns of neuronal activation in pain-related cortical areas.
An investigation on patients after a whiplash injury found that those patients with persistent moderate or severe symptoms at 6 months had displayed, soon after injury, widespread hypersensitivity. Therefore, central hypersensitivity may be an indicator of poor prognosis. An acute peripheral lesion may induce plasticity changes leading to central hypersensitivity in a subset of individuals. Such a hypersensitivity would facilitate the transition from acute to chronic pain and disability. This hypothesis has been investigated using a limited number of tests only in a limited number of individuals with whiplash injury, but not in any other condition.
Objective
To determine the prognostic value of different measures of mechanisms of central hypersensitivity in patients with acute low back pain.
Methods
140 consecutive Patients with acute low back pain, referred by general practice, will be studied prospectively. Primary prognostic variable will be the pain tolerance threshold at the second toe (the pressure intensity at which a further increase in pressure is deemed intolerable). Exploratory secondary prognostic variables are measures of mechanisms related to central hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs. widespread hypersensitivity; spinal cord modulation (electrophysiological measures of hypersensitivity and changes in receptive fields); modulation at brain level (descending modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be the occurrence of chronic low back pain at follow-up. The investigators will use least square logistic regression models to determine the association of central hypersensitivity with prognosis.
- Conditions
- Pain Measurement, Low Back Pain
- Keywords
- Neuroplasticity, Prognosis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Patients With Acute Low Back Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of chronic low back pain
Measured: 6 months after the acute episode
Secondary outcomes (1)
Mechanisms of central hypersensitivity
Measured: During the acute episode of low back pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Curatolo, MD, PhD, Study director, Dep. of Anesthesiology and Pain Therapy, Bern University HospitalMonika Müller, MD, PhD, Principal investigator, Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892411
- Sponsor's protocol ID
- KEK 103/08
- Status last verified
- Jul 2015
- First submitted
- 1 May 2009
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vuilleumier PH, Arguissain FG, Biurrun Manresa JA, Neziri AY, Nirkko AC, Andersen OK, Arendt-Nielsen L, Curatolo M. Psychophysical and Electrophysiological Evidence for Enhanced Pain Facilitation and Unaltered Pain Inhibition in Acute Low Back Pain Patients. J Pain. 2017 Nov;18(11):1313-1323. doi: 10.1016/j.jpain.2017.05.008. Epub 2017 Jun 20.
PubMed 28645867
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Measures of Central Hypersensitivity in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT00892411
- Acronym / sponsor ID
- KEK 103/08
- Conditions
- Pain Measurement, Low Back Pain
- Keywords
- Neuroplasticity, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 May 2009 (estimated)
- 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.
Background. Patients with chronic low back pain display hyperexcitability of the central nervous system (central hypersensitivity). Such hypersensitivity may occur in the acute phase and represent a risk factor for the development of chronic pain.
Objective. To determine the prognostic value of central hypersensitivity for the development of chronic low back pain.
Design. Prospective cohort study.
Setting. Primary care.
Patients. 140 individuals with acute low back pain and no history of chronic pain.
Outcomes. Primary prognostic variable will be the pain tolerance threshold at the second toe (the pressure intensity at which a further increase in pressure is deemed intolerable). Exploratory secondary prognostic variables are measures of mechanisms related to central hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs. widespread hypersensitivity; spinal cord modulation (electrophysiological measures of hypersensitivity and changes in receptive fields); modulation at brain level (descending modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be the occurrence of chronic low back pain at follow-up.
Main analysis. The investigators will use least square logistic regression models to determine the association of central hypersensitivity with prognosis.
Relevance. An understanding of the prognostic value of central hypersensitivity may allow an early stratification for treatment of individuals at risk of developing chronic low back pain. Subgroups of patients may be selected for clinical trials on novel pharmacological approaches for the prevention and treatment of central hypersensitivity.
Detailed description
Background
Prolonged afferent nociceptive input induces an increase in the excitability of central sensory neurons and plasticity changes that cause hyperexcitability of the central nervous system (central hypersensitivity. The hyperexcitable central nervous system amplifies the nociceptive signal, thereby producing an exaggerated pain response even in the presence of limited tissue damage.
Using quantitative sensory tests, central hypersensitivity has been detected in different chronic musculoskeletal pain syndromes. Patients with chronic low back pain display increased pain sensitivity and enlargement of the areas of referred pain after stimulation of tissues around and distant from the site of pain (i.e. the leg or the thumb), suggesting that widespread central hypersensitivity is associated with this condition. Functional reorganization of the cortex has been detected in different pain conditions, including low back pain. Using equal levels of sensory stimulation in patients and pain-free controls, patients with chronic low back pain showed more extensive patterns of neuronal activation in pain-related cortical areas.
An investigation on patients after a whiplash injury found that those patients with persistent moderate or severe symptoms at 6 months had displayed, soon after injury, widespread hypersensitivity. Therefore, central hypersensitivity may be an indicator of poor prognosis. An acute peripheral lesion may induce plasticity changes leading to central hypersensitivity in a subset of individuals. Such a hypersensitivity would facilitate the transition from acute to chronic pain and disability. This hypothesis has been investigated using a limited number of tests only in a limited number of individuals with whiplash injury, but not in any other condition.
Objective
To determine the prognostic value of different measures of mechanisms of central hypersensitivity in patients with acute low back pain.
Methods
140 consecutive Patients with acute low back pain, referred by general practice, will be studied prospectively. Primary prognostic variable will be the pain tolerance threshold at the second toe (the pressure intensity at which a further increase in pressure is deemed intolerable). Exploratory secondary prognostic variables are measures of mechanisms related to central hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs. widespread hypersensitivity; spinal cord modulation (electrophysiological measures of hypersensitivity and changes in receptive fields); modulation at brain level (descending modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be the occurrence of chronic low back pain at follow-up. The investigators will use least square logistic regression models to determine the association of central hypersensitivity with prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | –Patients With Acute Low Back Pain |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute low back pain referred from primary care.
Key inclusion criteria (2 listed)
- Acute low back pain < 6 weeks
- Age 18-80
Key exclusion criteria (4 listed)
- History of chronic low back pain
- Radicular pain
- Pregnancy
- Breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of chronic low back pain
Time frame: 6 months after the acute episode
1 secondary outcome
Mechanisms of central hypersensitivity
Time frame: During the acute episode of low back pain
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 17 Jul 2015.
- Derived from this study: PubMed 28645867Vuilleumier PH, Arguissain FG, Biurrun Manresa JA, Neziri AY, Nirkko AC, Andersen OK, Arendt-Nielsen L, Curatolo M. Psychophysical and Electrophysiological Evidence for Enhanced Pain Facilitation and Unaltered Pain Inhibition in Acute Low Back Pain Patients. J Pain. 2017 Nov;18(11):1313-1323. doi: 10.1016/j.jpain.2017.05.008. Epub 2017 Jun 20.
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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.
Michele Curatolo, MD, PhD study director
Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
Monika Müller, MD, PhD principal investigator
Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
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 Pain Measurement and Low Back Pain, run by Insel Gruppe AG, University Hospital Bern 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 2 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 17 Jul 2015. 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?
Presence or absence of chronic low back pain (time frame: 6 months after the acute episode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00892411, which also lists 1 linked publication.
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 17 Jul 2015.