Chronic PainNCT03966677
Sensory Abnormalities in Post-surgical Peripheral Neuropathy
An observational study of Chronic Pain, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The concept of normality is a cornerstone in medical practice and research. As an example, in clinical chemistry, a laboratory value based on a plasma sample exceeding the +/- 1.96 x standard deviation (SD) range, referenced from normative material, is, per definition, outside the normal range (the reference… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- How many people
- 162 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2019to 1 Sep 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study subjects with pain after GHR (P-GHR) (n=54) Study subjects without pain after GHR (NP-GHR) (n=54) Healthy non-operated study subjects (NP) (n=54)
Who may be able to join
- All study subjects must meet all the following criteria to be eligible to enroll in the study:
- Age above 18 yrs and below 65 yrs
- Signed informed consent
- Body mass index (BMI): 18 < BMI < 35 kg/m^2
- ASA I-II
- In addition, for study subjects without pain after GHR (NP-GHR):
Show all 9Show fewer
- having undergone uncomplicated, elective, unilateral open GHR a.m. Lichtenstein
- no restriction in ADL-functions due to the GHR
- activity-related groin pain < 3 (numerical rating scale [NRS]: 0 = no pain, 10 = worst imaginable pain)
Who cannot join
- Any study subject, who meets one or more of the following criteria, is not suitable for inclusion in this study:
- do not speak or understand Danish
- who cannot cooperate with the investigation
- abuse of alcohol or drugs - according to investigator's evaluation
- use of psychotropic drugs (exception of SSRI)
- neurologic or psychiatric disease
Show all 19Show fewer
- chronic pain condition
- regular use of analgesic drugs
- skin lesions or tattoos in the assessment areas (groins, lower arm)
- nerve lesions in the assessment sites (e.g., after trauma, abdominal surgery)
- In addition, for healthy non-operated study subjects (NP):
- subjects, who have had previous surgery in or near the groin region
- use of prescription drugs one week before the trial
- use of over-the-counter (OTC) drugs 48 hours before the trial
- experiencing pain at rest > 3 (NRS)
- experiencing activity-related pain in or near the groin > 3 (NRS)
- In addition, for study subjects without pain after GHR (NP-GHR):
- experiencing pain at rest > 3 (NRS)
- experiencing activity-related pain in or near the groin > 3 (NRS)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9
Copenhagen O, 2100
About this study
Official title: Sensory Abnormalities in Post-surgical Peripheral Neuropathy: A Comparison of Subjects With and Without Severe Pain Using Normative Data
The concept of normality is a cornerstone in medical practice and research. As an example, in clinical chemistry, a laboratory value based on a plasma sample exceeding the +/- 1.96 x standard deviation (SD) range, referenced from normative material, is, per definition, outside the normal range (the reference interval). Obviously, a number of reasons for this deviation may exist. The sample value could reflect a "true" pathological condition but could also be caused by error, e.g., technical measurement error, drug-interaction error, random error, or reflect a value occurring in 5% of the healthy population. Conversely, a sample value in the normal range evidently does not exclude a pathological condition.
The reference interval is calculated from a large number of healthy subjects sampled across age, anthropometrics, ethnicity, and gender. Normative reference intervals are certainly of help, particularly in the screening of subjects, but may be of limited value in the detailed assessment of pathophysiological processes. Also, increasing the number of analyses in a subject expands the risk of making a type I error (acquiring "false" positive results). The likelihood of one or more type I errors in the analysis of 10 different laboratory values in one subject is impressive 46% ([1 - 0.95^10] =0.46). It is well-known that multiple measurements are commonly performed in medical practice and research, but corrected significance levels are not always used.
Read the detailed description
Quantitative sensory testing (QST) is defined as perceptually quantifiable responses to graded chemical (capsaicin), electrical, mechanical (pressure, punctate, vibratory, and light touch), or thermal (cool, warmth, cold pain, and heat pain) stimuli. Thus, QST is a psychophysical method primarily assessing small nerve fiber function in the skin. The method is ubiquitously used for the assessment of peripheral neuropathies, e.g., chemotherapy-induced neuropathy, painful diabetic polyneuropathy, post-herpetic neuralgia, and post-surgical neuropathy. Sensory mapping and QST are essential tools in grading definite or probable neuropathic pain, as stated in the definition: "Demonstration of the distinct neuroanatomically plausible distribution by at least one confirmatory test." Thus, examining somatosensory profiles in chronic post-surgical pain (CPSP) could be an important step in distinguishing the pathophysiologic components behind the transition from acute to chronic pain. However, determining when a measured variable is abnormal is obviously of prime importance in somatosensory research. During the last decade, the German Research Network on Neuropathic Pain (DFNS) has acquired normative sensory data from healthy individuals using a standardized testing protocol. Clearly, a deviating sensory response from an individual with a painful peripheral neuropathy could be evaluated by use of these normative data and eventually be classified as an abnormal response (absolute approach).
However, other alternatives exist that, hypothetically, might provide improved diagnostic specificity and sensitivity. First, in unilateral sensory deficits (mono-neuropathies), assessments at the contralateral side are possible, allowing a comparison with the pathological side (relative approach). The within-subject variances (WSV) are often significantly smaller than the between-subject variances (BSV) in QST assessments. In a normative study including thermal assessments (n = 100), the WSV and the BSV ranged between 18-23% and 77-82% of the total variance, respectively. Correspondingly, in a study of individuals with post-thoracotomy pain syndrome, the estimated WSV and BSV were 5-28% and 72-95%, respectively. Thus, scenarios using the subject as their own control may reduce data variability and improve diagnostic efficacy. However, the use of a contralateral homologous area as a control area in sensory testing has been questioned by several authors. The occurrence of mirror image sensory dysfunction (MISD) may affect contralateral assessments, requiring a distant control area. Second, instead of using healthy controls in pain studies, the use of post-surgical pain-free individuals as controls (e.g. post-groin hernia repair, post-thoracotomy) has been recommended in chronic post-surgical pain studies.
In spite of the importance of selecting an optimally controlled research design, the research group is only aware of one QST study addressing the control-group problem, i.e., a study including individuals with complex regional pain syndrome type I (CRPS I) restricted to one extremity. The study examined the validity of using the contralateral side as a control compared to using normative data from healthy individuals. The study recommended that the contralateral side in CPRS I individuals should be used as a control (relative approach).
Thus, it may be inferred that the following approaches are available for evaluating sensory data from an anticipated pathological site: an empirical approach (á priori set reference values), an absolute approach (comparing the subject's pathological side with normative data), and a relative approach (comparing the subject's side-to-side differences with normative data).
The present study has a prospective, observational, three-cohort design comparing somatosensory profiles from a cohort with groin hernia repair (GHR) associated CPSP (P-GHR; n = 70) across two standard cohorts: one surgical cohort without CPSP (NP-GHR; n = 54) and another healthy non-surgical cohort (NOP; n = 54). Testing sites are the surgical groin, with the comparator sites, the non-surgical groin, and the lower arm. The QST assessments are compared across cohorts (P-GHR, NP-GHR, NOP), testing sides (surgical side, non-surgical side), and testing sites (groins, arm). The statistical processing is by linear mixed-effects models and z-transformations, using the NOP cohort as reference material.
The main objective is:
- To characterize and interpret the pathophysiologic substrate behind the somatosensory profiles in individuals with GHR-associated CPSP using relevant controls
Other objectives are:
- To examine the somatosensory data repeatability
- To determine the diagnostic efficiency of QST in identifying GHR-associated somatosensory abnormalities
- To compare the somatosensory testing efficacy of the absolute approach compared to the relative approach, using normative healthy controls
- To examine contralateral somatosensory abnormalities in individuals with/without GHR-associated CPSP
- Conditions
- Chronic Pain
- Keywords
- Groin hernia repair, Persistent postsurgical pain, Quantitative sensory testing (QST), Normative data
- Medical subject headings
- Chronic Pain, Pain, Postoperative
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 |
|---|---|---|
| P-GHR | Patients with persistent severe pain after groin hernia repair. | |
| NP-GHR | Patients without pain after groin hernia repair. | |
| NP | Healthy non-operated controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal thresholds
Warmth detection threshold (WDT), cool detection threshold, heat pain threshold (HPT) and cold pain threshold (CPT) are made by a computerized contact thermode (Thermotest, Somedic AB, Sweden) with an active thermal surface of 12.5 cm^2 (2.5 x 5.0 cm^2) as previously described in detail. The thresholds are determined from a baseline temperature of 32°C with a ramp rate of + 1°C/s. Cut-offs for heat and cold are 50°C and 5°C, respectively. The assessments are made in triplicate and the mean values are used in the statistical analyses.
Measured: 2019-2023
Pressure algometry
Deep-tissue pain sensitivity is assessed using a hand-held pressure algometer with a neoprene-coated tip of area 1.0 cm2 (Somedic AB, Sweden), as previously described. The algometer is applied perpendicularly to the skin with a pressure rate of 30 kPa/s. The study subject is told to report the pressure pain threshold (PPT) by activating the button device when pain is perceived. The cut-off limit is 350 kPa. Testing is done in triplicate and the average value is used in the statistical analyses.
Measured: 2019-2023
Suprathreshold heat stimulation
A short tonic heat stimulus (heating area 12.5 cm^2; ramp rate: 1°C/s, plateau: 47°C, 5 s; STH) is delivered in order to evaluate the suprathreshold heat pain perception (NRS).
Measured: 2019-2023
Sensory mapping
Sensory mapping in the groin areas is assessed with a 25°C metal roll (Somedic AB), moved at a rate of 1 to 2 cm/s from skin with normal cool perception, using an octagonal approach, into the areas in order to indicate sensory changes. Changes in the study subject's cool perception are indicated by a marker on the skin, and subsequently transferred to a transparent sheet for later area assessment in a vector-based drawing drawing program (Canvas 12.0; ACD Systems, Seattle, WA).
Measured: 2019-2023
Tactile thresholds
Tactile detection thresholds (TDT) and tactile pain threshold (TPT) are determined by polyamide monofilaments (Stoelting, IL, USA; nominal buckling force ranging from 0.04 to 4,400 mN) using a modified Dixon up-and-down method, with 3 descending and 3 ascending stimulus intensities. The filament with the smallest buckling force leading to tactile recognition (TDT) is registered. The tactile pain threshold (TPT) is determined by the same stimulus paradigm, but registering the perception of pain (sharpness/sting; TPT).
Measured: 2019-2023
Temporal summation
Temporal summation test, i.e., the perception in response to repetitive (0.3 to 3 Hz) mechanical stimulation [i.e., wind-up like pain: WUP], indicates presence of central sensitization. The repetitive 1 Hz stimuli for 60 s are either dynamically delivered by a brush or statically delivered by a polyamide filament (one nominal rank below TPT). The study subjects are told to report the level of pain (NRS) every 15 s-1 during the stimulation. Signs of aftersensations are followed 60 s after discontinuation of the stimulation, and the intensity of discomfort or pain is rated by NRS.
Measured: 2019-2023
Secondary outcomes (2)
Assessments of Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS; 14 items scale; 0-21 units)
Measured: 2019-2023
Assessment of Pain Catastrophizing
Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)
Measured: 2019-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jul 2019
- Primary completion28 Jun 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mads u werner, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966677
- Sponsor's protocol ID
- H-16034340
- Status last verified
- Feb 2024
- First submitted
- 25 May 2019
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://register.clinicaltrials.gov/prs/app/template/EditProtocol.vm?listmode=Edit\&uid=U000190V\&ts=15\&sid=S0008RBK\&cx=-gmj8tv
Publications
Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
PubMed 30586070Treede RD. The role of quantitative sensory testing in the prediction of chronic pain. Pain. 2019 May;160 Suppl 1:S66-S69. doi: 10.1097/j.pain.0000000000001544.
PubMed 31008852Reimer M, Forstenpointner J, Hartmann A, Otto JC, Vollert J, Gierthmuhlen J, Klein T, Hullemann P, Baron R. Sensory bedside testing: a simple stratification approach for sensory phenotyping. Pain Rep. 2020 May 21;5(3):e820. doi: 10.1097/PR9.0000000000000820. eCollection 2020 May-Jun.
PubMed 32903958Truini A, Aleksovska K, Anderson CC, Attal N, Baron R, Bennett DL, Bouhassira D, Cruccu G, Eisenberg E, Enax-Krumova E, Davis KD, Di Stefano G, Finnerup NB, Garcia-Larrea L, Hanafi I, Haroutounian S, Karlsson P, Rakusa M, Rice ASC, Sachau J, Smith BH, Sommer C, Tolle T, Valls-Sole J, Veluchamy A. Joint European Academy of Neurology-European Pain Federation-Neuropathic Pain Special Interest Group of the International Association for the Study of Pain guidelines on neuropathic pain assessment. Eur J Neurol. 2023 Aug;30(8):2177-2196. doi: 10.1111/ene.15831. Epub 2023 May 30.
PubMed 37253688Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
PubMed 27115670Pfau DB, Krumova EK, Treede RD, Baron R, Toelle T, Birklein F, Eich W, Geber C, Gerhardt A, Weiss T, Magerl W, Maier C. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): reference data for the trunk and application in patients with chronic postherpetic neuralgia. Pain. 2014 May;155(5):1002-1015. doi: 10.1016/j.pain.2014.02.004. Epub 2014 Feb 10.
PubMed 24525274Magerl W, Krumova EK, Baron R, Tolle T, Treede RD, Maier C. Reference data for quantitative sensory testing (QST): refined stratification for age and a novel method for statistical comparison of group data. Pain. 2010 Dec;151(3):598-605. doi: 10.1016/j.pain.2010.07.026. Epub 2010 Oct 20.
PubMed 20965658Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
PubMed 16697110Kemler MA, Schouten HJ, Gracely RH. Diagnosing sensory abnormalities with either normal values or values from contralateral skin: comparison of two approaches in complex regional pain syndrome I. Anesthesiology. 2000 Sep;93(3):718-27. doi: 10.1097/00000542-200009000-00021.
PubMed 10969305Rosenberger DC, Pogatzki-Zahn EM. Chronic post-surgical pain - update on incidence, risk factors and preventive treatment options. BJA Educ. 2022 May;22(5):190-196. doi: 10.1016/j.bjae.2021.11.008. Epub 2022 Feb 24. No abstract available.
PubMed 35496645
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Abnormalities in Post-surgical Peripheral Neuropathy: A Comparison of Subjects With and Without Severe Pain Using Normative Data
- ClinicalTrials.gov ID
- NCT03966677
- Acronym / sponsor ID
- H-16034340
- Conditions
- Chronic Pain
- Keywords
- Groin hernia repair, Persistent postsurgical pain, Quantitative sensory testing (QST), Normative data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 29 May 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 concept of normality is a cornerstone in medical practice and research. As an example, in clinical chemistry, a laboratory value based on a plasma sample exceeding the +/- 1.96 x standard deviation (SD) range, referenced from normative material, is, per definition, outside the normal range (the reference interval). Obviously, a number of reasons for this deviation may exist. The sample value could reflect a "true" pathological condition but could also be caused by error, e.g., technical measurement error, drug-interaction error, random error, or reflect a value occurring in 5% of the healthy population. Conversely, a sample value in the normal range evidently does not exclude a pathological condition.
The reference interval is calculated from a large number of healthy subjects sampled across age, anthropometrics, ethnicity, and gender. Normative reference intervals are certainly of help, particularly in the screening of subjects, but may be of limited value in the detailed assessment of pathophysiological processes. Also, increasing the number of analyses in a subject expands the risk of making a type I error (acquiring "false" positive results). The likelihood of one or more type I errors in the analysis of 10 different laboratory values in one subject is impressive 46% ([1 - 0.95^10] =0.46). It is well-known that multiple measurements are commonly performed in medical practice and research, but corrected significance levels are not always used.
Detailed description
Quantitative sensory testing (QST) is defined as perceptually quantifiable responses to graded chemical (capsaicin), electrical, mechanical (pressure, punctate, vibratory, and light touch), or thermal (cool, warmth, cold pain, and heat pain) stimuli. Thus, QST is a psychophysical method primarily assessing small nerve fiber function in the skin. The method is ubiquitously used for the assessment of peripheral neuropathies, e.g., chemotherapy-induced neuropathy, painful diabetic polyneuropathy, post-herpetic neuralgia, and post-surgical neuropathy. Sensory mapping and QST are essential tools in grading definite or probable neuropathic pain, as stated in the definition: "Demonstration of the distinct neuroanatomically plausible distribution by at least one confirmatory test." Thus, examining somatosensory profiles in chronic post-surgical pain (CPSP) could be an important step in distinguishing the pathophysiologic components behind the transition from acute to chronic pain. However, determining when a measured variable is abnormal is obviously of prime importance in somatosensory research. During the last decade, the German Research Network on Neuropathic Pain (DFNS) has acquired normative sensory data from healthy individuals using a standardized testing protocol. Clearly, a deviating sensory response from an individual with a painful peripheral neuropathy could be evaluated by use of these normative data and eventually be classified as an abnormal response (absolute approach).
However, other alternatives exist that, hypothetically, might provide improved diagnostic specificity and sensitivity. First, in unilateral sensory deficits (mono-neuropathies), assessments at the contralateral side are possible, allowing a comparison with the pathological side (relative approach). The within-subject variances (WSV) are often significantly smaller than the between-subject variances (BSV) in QST assessments. In a normative study including thermal assessments (n = 100), the WSV and the BSV ranged between 18-23% and 77-82% of the total variance, respectively. Correspondingly, in a study of individuals with post-thoracotomy pain syndrome, the estimated WSV and BSV were 5-28% and 72-95%, respectively. Thus, scenarios using the subject as their own control may reduce data variability and improve diagnostic efficacy. However, the use of a contralateral homologous area as a control area in sensory testing has been questioned by several authors. The occurrence of mirror image sensory dysfunction (MISD) may affect contralateral assessments, requiring a distant control area. Second, instead of using healthy controls in pain studies, the use of post-surgical pain-free individuals as controls (e.g. post-groin hernia repair, post-thoracotomy) has been recommended in chronic post-surgical pain studies.
In spite of the importance of selecting an optimally controlled research design, the research group is only aware of one QST study addressing the control-group problem, i.e., a study including individuals with complex regional pain syndrome type I (CRPS I) restricted to one extremity. The study examined the validity of using the contralateral side as a control compared to using normative data from healthy individuals. The study recommended that the contralateral side in CPRS I individuals should be used as a control (relative approach).
Thus, it may be inferred that the following approaches are available for evaluating sensory data from an anticipated pathological site: an empirical approach (á priori set reference values), an absolute approach (comparing the subject's pathological side with normative data), and a relative approach (comparing the subject's side-to-side differences with normative data).
The present study has a prospective, observational, three-cohort design comparing somatosensory profiles from a cohort with groin hernia repair (GHR) associated CPSP (P-GHR; n = 70) across two standard cohorts: one surgical cohort without CPSP (NP-GHR; n = 54) and another healthy non-surgical cohort (NOP; n = 54). Testing sites are the surgical groin, with the comparator sites, the non-surgical groin, and the lower arm. The QST assessments are compared across cohorts (P-GHR, NP-GHR, NOP), testing sides (surgical side, non-surgical side), and testing sites (groins, arm). The statistical processing is by linear mixed-effects models and z-transformations, using the NOP cohort as reference material.
The main objective is:
- To characterize and interpret the pathophysiologic substrate behind the somatosensory profiles in individuals with GHR-associated CPSP using relevant controls
Other objectives are:
- To examine the somatosensory data repeatability
- To determine the diagnostic efficiency of QST in identifying GHR-associated somatosensory abnormalities
- To compare the somatosensory testing efficacy of the absolute approach compared to the relative approach, using normative healthy controls
- To examine contralateral somatosensory abnormalities in individuals with/without GHR-associated CPSP
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P-GHR | – | –Patients with persistent severe pain after groin hernia repair. |
| NP-GHR | – | –Patients without pain after groin hernia repair. |
| NP | – | –Healthy non-operated controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects with pain after GHR (P-GHR) (n=54) Study subjects without pain after GHR (NP-GHR) (n=54) Healthy non-operated study subjects (NP) (n=54)
Key inclusion criteria (9 listed)
- All study subjects must meet all the following criteria to be eligible to enroll in the study:
- Age above 18 yrs and below 65 yrs
- Signed informed consent
- Body mass index (BMI): 18 < BMI < 35 kg/m^2
- ASA I-II
Key exclusion criteria (19 listed)
- Any study subject, who meets one or more of the following criteria, is not suitable for inclusion in this study:
- do not speak or understand Danish
- who cannot cooperate with the investigation
- abuse of alcohol or drugs - according to investigator's evaluation
- use of psychotropic drugs (exception of SSRI)
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
Thermal thresholds
Time frame: 2019-2023
Warmth detection threshold (WDT), cool detection threshold, heat pain threshold (HPT) and cold pain threshold (CPT) are made by a computerized contact thermode (Thermotest, Somedic AB, Sweden) with an active thermal surface of 12.5 cm^2 (2.5 x 5.0 cm^2) as previously described in detail. The thresholds are determined from a baseline temperature of 32°C with a ramp rate of + 1°C/s. Cut-offs for heat and cold are 50°C and 5°C, respectively. The assessments are made in triplicate and the mean values are used in the statistical analyses.
Pressure algometry
Time frame: 2019-2023
Deep-tissue pain sensitivity is assessed using a hand-held pressure algometer with a neoprene-coated tip of area 1.0 cm2 (Somedic AB, Sweden), as previously described. The algometer is applied perpendicularly to the skin with a pressure rate of 30 kPa/s. The study subject is told to report the pressure pain threshold (PPT) by activating the button device when pain is perceived. The cut-off limit is 350 kPa. Testing is done in triplicate and the average value is used in the statistical analyses.
Suprathreshold heat stimulation
Time frame: 2019-2023
A short tonic heat stimulus (heating area 12.5 cm^2; ramp rate: 1°C/s, plateau: 47°C, 5 s; STH) is delivered in order to evaluate the suprathreshold heat pain perception (NRS).
Sensory mapping
Time frame: 2019-2023
Sensory mapping in the groin areas is assessed with a 25°C metal roll (Somedic AB), moved at a rate of 1 to 2 cm/s from skin with normal cool perception, using an octagonal approach, into the areas in order to indicate sensory changes. Changes in the study subject's cool perception are indicated by a marker on the skin, and subsequently transferred to a transparent sheet for later area assessment in a vector-based drawing drawing program (Canvas 12.0; ACD Systems, Seattle, WA).
Tactile thresholds
Time frame: 2019-2023
Tactile detection thresholds (TDT) and tactile pain threshold (TPT) are determined by polyamide monofilaments (Stoelting, IL, USA; nominal buckling force ranging from 0.04 to 4,400 mN) using a modified Dixon up-and-down method, with 3 descending and 3 ascending stimulus intensities. The filament with the smallest buckling force leading to tactile recognition (TDT) is registered. The tactile pain threshold (TPT) is determined by the same stimulus paradigm, but registering the perception of pain (sharpness/sting; TPT).
Temporal summation
Time frame: 2019-2023
Temporal summation test, i.e., the perception in response to repetitive (0.3 to 3 Hz) mechanical stimulation [i.e., wind-up like pain: WUP], indicates presence of central sensitization. The repetitive 1 Hz stimuli for 60 s are either dynamically delivered by a brush or statically delivered by a polyamide filament (one nominal rank below TPT). The study subjects are told to report the level of pain (NRS) every 15 s-1 during the stimulation. Signs of aftersensations are followed 60 s after discontinuation of the stimulation, and the intensity of discomfort or pain is rated by NRS.
2 secondary outcomes
Assessments of Anxiety and Depression
Time frame: 2019-2023
Assessment of Pain Catastrophizing
Time frame: 2019-2023
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 22 Feb 2024.
- Background: PubMed 30586070Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
- Background: PubMed 31008852Treede RD. The role of quantitative sensory testing in the prediction of chronic pain. Pain. 2019 May;160 Suppl 1:S66-S69. doi: 10.1097/j.pain.0000000000001544.
- Background: PubMed 32903958Reimer M, Forstenpointner J, Hartmann A, Otto JC, Vollert J, Gierthmuhlen J, Klein T, Hullemann P, Baron R. Sensory bedside testing: a simple stratification approach for sensory phenotyping. Pain Rep. 2020 May 21;5(3):e820. doi: 10.1097/PR9.0000000000000820. eCollection 2020 May-Jun.
- Background: PubMed 37253688Truini A, Aleksovska K, Anderson CC, Attal N, Baron R, Bennett DL, Bouhassira D, Cruccu G, Eisenberg E, Enax-Krumova E, Davis KD, Di Stefano G, Finnerup NB, Garcia-Larrea L, Hanafi I, Haroutounian S, Karlsson P, Rakusa M, Rice ASC, Sachau J, Smith BH, Sommer C, Tolle T, Valls-Sole J, Veluchamy A. Joint European Academy of Neurology-European Pain Federation-Neuropathic Pain Special Interest Group of the International Association for the Study of Pain guidelines on neuropathic pain assessment. Eur J Neurol. 2023 Aug;30(8):2177-2196. doi: 10.1111/ene.15831. Epub 2023 May 30.
- Background: PubMed 27115670Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
- Background: PubMed 24525274Pfau DB, Krumova EK, Treede RD, Baron R, Toelle T, Birklein F, Eich W, Geber C, Gerhardt A, Weiss T, Magerl W, Maier C. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): reference data for the trunk and application in patients with chronic postherpetic neuralgia. Pain. 2014 May;155(5):1002-1015. doi: 10.1016/j.pain.2014.02.004. Epub 2014 Feb 10.
- Background: PubMed 20965658Magerl W, Krumova EK, Baron R, Tolle T, Treede RD, Maier C. Reference data for quantitative sensory testing (QST): refined stratification for age and a novel method for statistical comparison of group data. Pain. 2010 Dec;151(3):598-605. doi: 10.1016/j.pain.2010.07.026. Epub 2010 Oct 20.
- Background: PubMed 16697110Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
- Background: PubMed 10969305Kemler MA, Schouten HJ, Gracely RH. Diagnosing sensory abnormalities with either normal values or values from contralateral skin: comparison of two approaches in complex regional pain syndrome I. Anesthesiology. 2000 Sep;93(3):718-27. doi: 10.1097/00000542-200009000-00021.
- Background: PubMed 35496645Rosenberger DC, Pogatzki-Zahn EM. Chronic post-surgical pain - update on incidence, risk factors and preventive treatment options. BJA Educ. 2022 May;22(5):190-196. doi: 10.1016/j.bjae.2021.11.008. Epub 2022 Feb 24. No abstract available.
- Individual participant dataSharing planned: Yes. https://register.clinicaltrials.gov/prs/app/template/EditProtocol.vm?listmode=Edit\&uid=U000190V\&ts=15\&sid=S0008RBK\&cx=-gmj8tv
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Pain, run by University of Copenhagen at 1 site 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 9 inclusion and 19 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 22 Feb 2024. 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 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?
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?
Thermal thresholds (time frame: 2019-2023). The study lists 6 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 NCT03966677, which also lists 10 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 22 Feb 2024.