PainBonemetPAINNCT03908853
Pain Phenotyping of Patients With Bone Cancer Pain
An observational study of Pain and Bone Metastases, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
The study aims to describe and quantify pain related to metastatic bone disease. The study will include 50 subjects with disseminated breast cancer and 20 healthy subjects. The pain will be described and quantified through (1) pain specific questionnaires, (2) quantitative sensory testing that assess sensory changes… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Bone Metastases, Metastatic Breast Cancer
- How many people
- 70 participants
- Where
- 2 sitesDenmark
- Study dates
- 5 Feb 2019to 1 Feb 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 subjects with bone metastases caused by primary breast cancer and 20 healthy volunteers.
Who may be able to join
- Woman
- Primary breast cancer
- Bone metastases
- Competent
Who cannot join
- Not fluent in spoken Danish
- Chemotherapy or radiation within the last 3 months
- Other chronic pain disease that may affect the quantitative sensory testing or conditioned pain modulation
- Alcohol or medicine abuse
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Oncology, Rigshospitalet
Copenhagen, 2100
Rie B Hansen, PhD
- Recruiting
The Department of Oncology, Herlev Hospital
Herlev, 2730
Rie B Hansen, PhD
About this study
The study aims to describe and quantify pain related to metastatic bone disease. The study will include 50 subjects with disseminated breast cancer and 20 healthy subjects. The pain will be described and quantified through (1) pain specific questionnaires, (2) quantitative sensory testing that assess sensory changes to cold, heat and mechanical stimulation of the skin overlying the metastatic site, and (3) conditioned pain modulation that investigates impairment of the endogenous inhibitory pain pathway in humans.
Read the detailed description
Cancer patients in palliative care point to pain as their most important and most feared symptom. Bone metastases are a common cause of cancer pain, and the patients are prone to transient severe pain exacerbations (breakthrough pain), which can occur spontaneously or be triggered by movement. Patients with bone metastases experience pain of such high intensity, that it affects not only physical activity, but also sleep, mood and social relations. This results in poor quality of life for the patients and poses an increasing clinical and socio-economical problem. The pain is difficult to treat and often requires high opioid doses which results in unacceptable adverse effects, and there is an unmet need of novel therapeutic options and treatment strategies.
Animal models of cancer-induced bone pain have suggested that pain arising from metastatic bone disease involve neuropathic and nociceptive pain mechanisms and, importantly, mechanisms that are specific to cancer-induced bone pain. Significant neuronal sprouting can occur at the metastatic site, and the inherent pain control system is found altered in animal models of cancer-induced bone pain; a system that can be exploited for treatment strategies and in the development of new analgesia. Yet, it is not known how the pre-clinical findings translate to patients.
Quantitative sensory testing is a psychophysical method that uses a battery of sensory stimuli with predetermined physical properties, thus allowing the capture and quantification of stimulus-evoked negative and positive sensory phenomena in humans. Conditioned pain modulation is a psychophysical experimental measure of the endogenous pain inhibitory pathway in humans, which can be used to detect an impairment of the descending inhibitory pain pathway.
This study aims to perform pain phenotyping of patients suffering from cancer-induced bone pain, through pain specific questionnaires, quantitative sensory testing and conditioned pain modulation.
- Conditions
- Pain, Bone Metastases, Metastatic Breast Cancer
- Medical subject headings
- Pain, Breast Neoplasms
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 |
|---|---|---|
| Patients | Subjects with painful bone metastases caused by primary breast cancer. | |
| Controls | Gender and age matched healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned pain modulation (CPM) determined by cuff pressure algometry
CPM will be determined by placing two inflatable cuffs around the lower legs; one providing a test stimulus and the other a conditioning stimulus. First, the pressure pain detection and tolerance thresholds (kPa) are determined on each lower leg using an increasing pressure of 1 kPa/s; next a constant conditioning stimulus is applied to the dominant lower leg and 10 seconds later the pain pressure detection and tolerance threshold (kPa) are simultaneously determined on the non-dominant leg. The CPM effect is assessed as the percent difference between the measured thresholds on the non-dominant lower leg.
Measured: 1 day
Sensory mapping with thermorollers and brush
Sensory changes to cold, warm and dynamic mechanical stimulation with thermo rollers (25°C and 40°C) and a standardized brush (No. 5, Somedic). Determination of area with either increased, decreased or painful changes.
Measured: 1 day
Secondary outcomes (8)
Mechanical pain threshold with PinPrick.
Determination of the mechanical pain threshold with PinPricks using a series of five ascending and five descending stimulus intensities (range 8 mN - 512 mN). The threshold is calculated as the geometric mean of the supra- and sub-threshold readings (mN).
Measured: 1 day
Wind up ratio with Pin Prick
Determination of the pain rating (numeric rating scale, range 0-100) to 10 repeated stimuli with either a standardized brush or a PinPrick (256 mN). The wind up ratio is calculated as the arithmetic mean of the pain intensity rating for the series of stimuli divided by the arithmetic mean of the pain intensity rating for the single stimulus.
Measured: 1 day
Cuff pressure pain threshold and pressure pain tolerance determined by cuff pressure algometry
Pressure pain detecting threshold and pain tolerance threshold (kPa) will be determined by placing two inflatable cuffs around the lower legs. The two thresholds are determined at the same time using an increasing pressure of 1 kPa/s.
Measured: 1 day
Temporal summation of pressure pain
Determination of the pain rating (VAS, range 0-10) to 10 repeated stimuli with cuff pressure (pain tolerance threshold). The wind up ratio is calculated as the difference between the normalized mean of the pain intensity rating for the last series of stimuli divided by the normalized mean of the pain intensity rating for first stimuli.
Measured: 1 day
Questionnaire - The Short Form Brief Pain Inventory
The short form Brief Pain Inventory measures pain intensity, localization of pain and influence on daily activities and quality of life through 9 items. All items cover the last 24 hours.
Measurement of worst, least, average and current pain on a scale from 0-10, where 0 equals "no pain" and 10 equals "pain as bad as you can imagine"; the measures are used individually or combined into a mean severity score.
Determination of pain localization using a pain drawing (human figure); the information is used qualitatively.
Determination of pain relief on a scale from 0-100%. Measurement of how much pain interferes with daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep; the measurement is done on a scale from 0-10, where 0 equals "does no interference" and 10 equals "completely interferes"; the seven interference items are combined into a mean score.
Measured: 1 day
Questionnaire - PainDETECT
Screens for neuropathic pain components through 13 items. Measurement of current, strongest and average pain within the last 4 weeks on a scale from 0-10, 0 equals "none" and 10 equals "maximal"; the measures are used individually.
Marking of pain pattern (persistent, fluctuating) according to 4 pictures; a score from -1 to +1 is given depending on pain pattern.
Determination of pain localization using a pain drawing and indication of pain radiating to other body regions; radiating pain will give a score of +2.
Determination of the sensation of the pain (e.g. burning, prickling, numbness) using 7 items; the scale includes the following choices resulting in the indicated scores; never (0), hardly noticed (+1), slightly (+2), moderately (+3), strongly (+4), and very strongly (+5).
The total score is calculated (ranging from 0-38) and the number used to determine the likelihood of a neuropathic pain component with 0-12 resulting in negative, 13-18 unclear and 19-30 positive.
Measured: 1 day
Questionnaire - The Breakthrough Pain Questionnaire
The Breakthrough Pain Questionnaire is used to assess breakthrough pain intensity, frequency, duration, and triggering and relieving factors through 9 items. The obtained measures are used individually and some only qualitatively.
Measurement of average background and breakthrough pain within the last 24 hours on a scale from 0-10, where 0 equals "no pain" and 10 equals "worst pain imaginable".
Indication of breakthrough pain episodes within the last 24 hours. Indication of average duration of breakthrough pain episodes using six time intervals ranging from "less than one minute" to "more than 120 minutes"; indication of the time from onset to peak pain using five time intervals ranging from "less than 10 seconds" to "31-60 minutes"; and indication of the predictability of breakthrough pain episodes ranging from "never" to "always".
Indication of triggering and relieving factors choosing statements such as "when I move", "when I sit" and "taking prescribed pain medication".
Measured: 1 day
Questionnaire - Pain Catastrophizing Scale
The Pain Catastrophizing Scale assess catastrophising related to pain experience through 13 items.
The subject evaluates 13 statements describing thoughts and feelings that may be associated to pain, e.g. "I feel I can't go on" and "I keep thinking of other painful events", and indicates the degree to which she has these thoughts when experiencing pain. The scale for all items includes the following choices resulting in the scores indicated in brackets; not at all (0), to a slight degree (+1), to a moderate degree (+2), to a great degree (+3), and all the time (+4).
The total score is calculated (ranging from 0-52) with a score of 30 or more representing a clinically relevant level of catastrophizing. Three subscales can be calculated: rumination (sum of four items), magnification (sum of three items), and helplessness (sum of six items), with cut-off scores of for clinically relevant levels at 11, 5 and 13, respectively.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start5 Feb 2019
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Responsible party
- Principal investigator, Anne-Marie Heegaard, University of Copenhagen
- Investigators
- Anne-Marie Heegaard, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908853
- Sponsor's protocol ID
- H-18041465
- Acronym
- BonemetPAIN
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stromgren AS, Sjogren P, Goldschmidt D, Petersen MA, Pedersen L, Groenvold M. Symptom priority and course of symptomatology in specialized palliative care. J Pain Symptom Manage. 2006 Mar;31(3):199-206. doi: 10.1016/j.jpainsymman.2005.07.007.
PubMed 16563314Banning A, Sjogren P, Henriksen H. Treatment outcome in a multidisciplinary cancer pain clinic. Pain. 1991 Nov;47(2):129-134. doi: 10.1016/0304-3959(91)90195-4. No abstract available.
PubMed 1762805Mercadante S. Managing difficult pain conditions in the cancer patient. Curr Pain Headache Rep. 2014 Feb;18(2):395. doi: 10.1007/s11916-013-0395-y.
PubMed 24407750Laird BJ, Walley J, Murray GD, Clausen E, Colvin LA, Fallon MT. Characterization of cancer-induced bone pain: an exploratory study. Support Care Cancer. 2011 Sep;19(9):1393-401. doi: 10.1007/s00520-010-0961-3. Epub 2010 Aug 1.
PubMed 20680354Hald A, Nedergaard S, Hansen RR, Ding M, Heegaard AM. Differential activation of spinal cord glial cells in murine models of neuropathic and cancer pain. Eur J Pain. 2009 Feb;13(2):138-45. doi: 10.1016/j.ejpain.2008.03.014. Epub 2008 May 21.
PubMed 18499488Bloom AP, Jimenez-Andrade JM, Taylor RN, Castaneda-Corral G, Kaczmarska MJ, Freeman KT, Coughlin KA, Ghilardi JR, Kuskowski MA, Mantyh PW. Breast cancer-induced bone remodeling, skeletal pain, and sprouting of sensory nerve fibers. J Pain. 2011 Jun;12(6):698-711. doi: 10.1016/j.jpain.2010.12.016. Epub 2011 Apr 15.
PubMed 21497141Donovan-Rodriguez T, Urch CE, Dickenson AH. Evidence of a role for descending serotonergic facilitation in a rat model of cancer-induced bone pain. Neurosci Lett. 2006 Jan 30;393(2-3):237-42. doi: 10.1016/j.neulet.2005.09.073. Epub 2005 Oct 25.
PubMed 16256273Honore P, Rogers SD, Schwei MJ, Salak-Johnson JL, Luger NM, Sabino MC, Clohisy DR, Mantyh PW. Murine models of inflammatory, neuropathic and cancer pain each generates a unique set of neurochemical changes in the spinal cord and sensory neurons. Neuroscience. 2000;98(3):585-98. doi: 10.1016/s0306-4522(00)00110-x.
PubMed 10869852Falk S, Patel R, Heegaard A, Mercadante S, Dickenson AH. Spinal neuronal correlates of tapentadol analgesia in cancer pain: a back-translational approach. Eur J Pain. 2015 Feb;19(2):152-8. doi: 10.1002/ejp.530. Epub 2014 Jun 11.
PubMed 24917026Kennedy DL, Kemp HI, Ridout D, Yarnitsky D, Rice ASC. Reliability of conditioned pain modulation: a systematic review. Pain. 2016 Nov;157(11):2410-2419. doi: 10.1097/j.pain.0000000000000689.
PubMed 27559835Rolke R, Magerl W, Campbell KA, Schalber C, Caspari S, Birklein F, Treede RD. Quantitative sensory testing: a comprehensive protocol for clinical trials. Eur J Pain. 2006 Jan;10(1):77-88. doi: 10.1016/j.ejpain.2005.02.003.
PubMed 16291301Yarnitsky D, Granot M, Nahman-Averbuch H, Khamaisi M, Granovsky Y. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy. Pain. 2012 Jun;153(6):1193-1198. doi: 10.1016/j.pain.2012.02.021. Epub 2012 Apr 3.
PubMed 22480803
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Phenotyping of Patients With Bone Cancer Pain
- ClinicalTrials.gov ID
- NCT03908853
- Acronym / sponsor ID
- BonemetPAIN / H-18041465
- Conditions
- Pain, Bone Metastases, Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 9 Apr 2019 (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 study aims to describe and quantify pain related to metastatic bone disease. The study will include 50 subjects with disseminated breast cancer and 20 healthy subjects. The pain will be described and quantified through (1) pain specific questionnaires, (2) quantitative sensory testing that assess sensory changes to cold, heat and mechanical stimulation of the skin overlying the metastatic site, and (3) conditioned pain modulation that investigates impairment of the endogenous inhibitory pain pathway in humans.
Detailed description
Cancer patients in palliative care point to pain as their most important and most feared symptom. Bone metastases are a common cause of cancer pain, and the patients are prone to transient severe pain exacerbations (breakthrough pain), which can occur spontaneously or be triggered by movement. Patients with bone metastases experience pain of such high intensity, that it affects not only physical activity, but also sleep, mood and social relations. This results in poor quality of life for the patients and poses an increasing clinical and socio-economical problem. The pain is difficult to treat and often requires high opioid doses which results in unacceptable adverse effects, and there is an unmet need of novel therapeutic options and treatment strategies.
Animal models of cancer-induced bone pain have suggested that pain arising from metastatic bone disease involve neuropathic and nociceptive pain mechanisms and, importantly, mechanisms that are specific to cancer-induced bone pain. Significant neuronal sprouting can occur at the metastatic site, and the inherent pain control system is found altered in animal models of cancer-induced bone pain; a system that can be exploited for treatment strategies and in the development of new analgesia. Yet, it is not known how the pre-clinical findings translate to patients.
Quantitative sensory testing is a psychophysical method that uses a battery of sensory stimuli with predetermined physical properties, thus allowing the capture and quantification of stimulus-evoked negative and positive sensory phenomena in humans. Conditioned pain modulation is a psychophysical experimental measure of the endogenous pain inhibitory pathway in humans, which can be used to detect an impairment of the descending inhibitory pain pathway.
This study aims to perform pain phenotyping of patients suffering from cancer-induced bone pain, through pain specific questionnaires, quantitative sensory testing and conditioned pain modulation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Subjects with painful bone metastases caused by primary breast cancer. |
| Controls | – | –Gender and age matched healthy volunteers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 subjects with bone metastases caused by primary breast cancer and 20 healthy volunteers.
Key inclusion criteria (4 listed)
- Woman
- Primary breast cancer
- Bone metastases
- Competent
Key exclusion criteria (5 listed)
- Not fluent in spoken Danish
- Chemotherapy or radiation within the last 3 months
- Other chronic pain disease that may affect the quantitative sensory testing or conditioned pain modulation
- Alcohol or medicine abuse
- Pregnancy
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
Conditioned pain modulation (CPM) determined by cuff pressure algometry
Time frame: 1 day
CPM will be determined by placing two inflatable cuffs around the lower legs; one providing a test stimulus and the other a conditioning stimulus. First, the pressure pain detection and tolerance thresholds (kPa) are determined on each lower leg using an increasing pressure of 1 kPa/s; next a constant conditioning stimulus is applied to the dominant lower leg and 10 seconds later the pain pressure detection and tolerance threshold (kPa) are simultaneously determined on the non-dominant leg. The CPM effect is assessed as the percent difference between the measured thresholds on the non-dominant lower leg.
Sensory mapping with thermorollers and brush
Time frame: 1 day
Sensory changes to cold, warm and dynamic mechanical stimulation with thermo rollers (25°C and 40°C) and a standardized brush (No. 5, Somedic). Determination of area with either increased, decreased or painful changes.
8 secondary outcomes
Mechanical pain threshold with PinPrick.
Time frame: 1 day
Wind up ratio with Pin Prick
Time frame: 1 day
Cuff pressure pain threshold and pressure pain tolerance determined by cuff pressure algometry
Time frame: 1 day
Temporal summation of pressure pain
Time frame: 1 day
Questionnaire - The Short Form Brief Pain Inventory
Time frame: 1 day
Questionnaire - PainDETECT
Time frame: 1 day
Questionnaire - The Breakthrough Pain Questionnaire
Time frame: 1 day
Questionnaire - Pain Catastrophizing Scale
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Background: PubMed 16563314Stromgren AS, Sjogren P, Goldschmidt D, Petersen MA, Pedersen L, Groenvold M. Symptom priority and course of symptomatology in specialized palliative care. J Pain Symptom Manage. 2006 Mar;31(3):199-206. doi: 10.1016/j.jpainsymman.2005.07.007.
- Background: PubMed 1762805Banning A, Sjogren P, Henriksen H. Treatment outcome in a multidisciplinary cancer pain clinic. Pain. 1991 Nov;47(2):129-134. doi: 10.1016/0304-3959(91)90195-4. No abstract available.
- Background: PubMed 24407750Mercadante S. Managing difficult pain conditions in the cancer patient. Curr Pain Headache Rep. 2014 Feb;18(2):395. doi: 10.1007/s11916-013-0395-y.
- Background: PubMed 20680354Laird BJ, Walley J, Murray GD, Clausen E, Colvin LA, Fallon MT. Characterization of cancer-induced bone pain: an exploratory study. Support Care Cancer. 2011 Sep;19(9):1393-401. doi: 10.1007/s00520-010-0961-3. Epub 2010 Aug 1.
- Background: PubMed 18499488Hald A, Nedergaard S, Hansen RR, Ding M, Heegaard AM. Differential activation of spinal cord glial cells in murine models of neuropathic and cancer pain. Eur J Pain. 2009 Feb;13(2):138-45. doi: 10.1016/j.ejpain.2008.03.014. Epub 2008 May 21.
- Background: PubMed 21497141Bloom AP, Jimenez-Andrade JM, Taylor RN, Castaneda-Corral G, Kaczmarska MJ, Freeman KT, Coughlin KA, Ghilardi JR, Kuskowski MA, Mantyh PW. Breast cancer-induced bone remodeling, skeletal pain, and sprouting of sensory nerve fibers. J Pain. 2011 Jun;12(6):698-711. doi: 10.1016/j.jpain.2010.12.016. Epub 2011 Apr 15.
- Background: PubMed 16256273Donovan-Rodriguez T, Urch CE, Dickenson AH. Evidence of a role for descending serotonergic facilitation in a rat model of cancer-induced bone pain. Neurosci Lett. 2006 Jan 30;393(2-3):237-42. doi: 10.1016/j.neulet.2005.09.073. Epub 2005 Oct 25.
- Background: PubMed 10869852Honore P, Rogers SD, Schwei MJ, Salak-Johnson JL, Luger NM, Sabino MC, Clohisy DR, Mantyh PW. Murine models of inflammatory, neuropathic and cancer pain each generates a unique set of neurochemical changes in the spinal cord and sensory neurons. Neuroscience. 2000;98(3):585-98. doi: 10.1016/s0306-4522(00)00110-x.
- Background: PubMed 24917026Falk S, Patel R, Heegaard A, Mercadante S, Dickenson AH. Spinal neuronal correlates of tapentadol analgesia in cancer pain: a back-translational approach. Eur J Pain. 2015 Feb;19(2):152-8. doi: 10.1002/ejp.530. Epub 2014 Jun 11.
- Background: PubMed 27559835Kennedy DL, Kemp HI, Ridout D, Yarnitsky D, Rice ASC. Reliability of conditioned pain modulation: a systematic review. Pain. 2016 Nov;157(11):2410-2419. doi: 10.1097/j.pain.0000000000000689.
- Background: PubMed 16291301Rolke R, Magerl W, Campbell KA, Schalber C, Caspari S, Birklein F, Treede RD. Quantitative sensory testing: a comprehensive protocol for clinical trials. Eur J Pain. 2006 Jan;10(1):77-88. doi: 10.1016/j.ejpain.2005.02.003.
- Background: PubMed 22480803Yarnitsky D, Granot M, Nahman-Averbuch H, Khamaisi M, Granovsky Y. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy. Pain. 2012 Jun;153(6):1193-1198. doi: 10.1016/j.pain.2012.02.021. Epub 2012 Apr 3.
- 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.
Anne-Marie Heegaard, PhD principal investigator
University of Copenhagen
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 Pain and Bone Metastases, run by University of Copenhagen at 2 sites in Denmark.
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 4 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 2 Mar 2021. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Marie Heegaard, PhD (+45 35336322, amhe@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned pain modulation (CPM) determined by cuff pressure algometry (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03908853, which also lists 12 linked publications.
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 2 Mar 2021.