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出境医 / 临床实验 / Sensory Abnormalities in Post-surgical Peripheral Neuropathy

Sensory Abnormalities in Post-surgical Peripheral Neuropathy

Study Description
Brief 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 patient plasma sample, exceeding the +/- 1.96 x standard deviation (SD) range, referenced from a 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 just as well 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.


Condition or disease
Chronic Pain

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." 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 a patient with a painful peripheral neuropathy could be evaluated by use of these normative data and eventually be classified as an abnormal response.

But, other alternatives exist, that hypothetically might provide an 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. 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 patients with the post-thoracotomy pain syndrome, the estimated WSV and BSV were 5-28% and 72-95%, respectively. Thus, scenarios using the subject as 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 neutral control area in the subject. Second, instead of using healthy controls in pain studies, use of pain-free patients (e.g. post-groin hernia repair, post-thoracotomy) as controls have been recommended in persistent 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, adressing the control-group problem, i.e., a study including patients with complex regional pain syndrome type I (CRPS I) restricted to one extremity. The study examined the validity of using the contralateral side as control compared to using normative data from healthy individuals. The study recommended that the contralateral side in CPRS I patients should be used as a control.

Thus it may be inferred, that following approaches are available 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).

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 162 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensory Abnormalities in Post-surgical Peripheral Neuropathy: A Comparison of Subjects With and Without Severe Pain Using Normative Data
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2021
Arms and Interventions
Group/Cohort
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
Outcome Measures
Primary Outcome Measures :
  1. Thermal thresholds [ Time Frame: 2019-2020 ]
    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.

  2. Pressure algometry [ Time Frame: 2019-2020 ]
    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.

  3. Suprathreshold heat stimulation [ Time Frame: 2019-2020 ]
    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).

  4. Sensory mapping [ Time Frame: 2019-2020 ]
    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).

  5. Tactile thresholds [ Time Frame: 2019-2020 ]
    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).

  6. Temporal summation [ Time Frame: 2019-2020 ]
    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.


Secondary Outcome Measures :
  1. Assessments of Anxiety and Depression [ Time Frame: 2019-2020 ]
    Hospital Anxiety and Depression Scale (HADS; 14 items scale; 0-21 units)

  2. Assessment of Pain Catastrophizing [ Time Frame: 2019-2020 ]
    Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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)
Criteria

INCLUSION CRITERIA:

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):

  • 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)

EXCLUSION CRITERIA:

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
  • 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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Mads U Werner, MD DMSc 28257703 ext 45 mads.u.werner@gmail.com

Locations
Layout table for location information
Denmark
Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet, Blegdamsvej 9 Recruiting
Copenhagen O, Denmark, 2100
Contact: Mads U Werner, MD DMSc    +45 28257703    mads.u.werner@gmail.com   
Principal Investigator: Elisabeth K Jensen, MB         
Sponsors and Collaborators
University of Copenhagen
Tracking Information
First Submitted Date May 25, 2019
First Posted Date May 29, 2019
Last Update Posted Date June 4, 2019
Estimated Study Start Date July 1, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2019)
  • Thermal thresholds [ Time Frame: 2019-2020 ]
    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: 2019-2020 ]
    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: 2019-2020 ]
    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: 2019-2020 ]
    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: 2019-2020 ]
    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: 2019-2020 ]
    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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 25, 2019)
  • Assessments of Anxiety and Depression [ Time Frame: 2019-2020 ]
    Hospital Anxiety and Depression Scale (HADS; 14 items scale; 0-21 units)
  • Assessment of Pain Catastrophizing [ Time Frame: 2019-2020 ]
    Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sensory Abnormalities in Post-surgical Peripheral Neuropathy
Official Title Sensory Abnormalities in Post-surgical Peripheral Neuropathy: A Comparison of Subjects With and Without Severe Pain Using Normative Data
Brief 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 patient plasma sample, exceeding the +/- 1.96 x standard deviation (SD) range, referenced from a 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 just as well 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." 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 a patient with a painful peripheral neuropathy could be evaluated by use of these normative data and eventually be classified as an abnormal response.

But, other alternatives exist, that hypothetically might provide an 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. 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 patients with the post-thoracotomy pain syndrome, the estimated WSV and BSV were 5-28% and 72-95%, respectively. Thus, scenarios using the subject as 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 neutral control area in the subject. Second, instead of using healthy controls in pain studies, use of pain-free patients (e.g. post-groin hernia repair, post-thoracotomy) as controls have been recommended in persistent 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, adressing the control-group problem, i.e., a study including patients with complex regional pain syndrome type I (CRPS I) restricted to one extremity. The study examined the validity of using the contralateral side as control compared to using normative data from healthy individuals. The study recommended that the contralateral side in CPRS I patients should be used as a control.

Thus it may be inferred, that following approaches are available 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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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)
Condition Chronic Pain
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *
  • Werner MU, Mjöbo HN, Nielsen PR, Rudin A. Prediction of postoperative pain: a systematic review of predictive experimental pain studies. Anesthesiology. 2010 Jun;112(6):1494-502. doi: 10.1097/ALN.0b013e3181dcd5a0. Review.
  • Mücke M, Cuhls H, Radbruch L, Baron R, Maier C, Tölle T, Treede RD, Rolke R. Quantitative sensory testing (QST). English version. Schmerz. 2016 Jan 29. [Epub ahead of print]
  • Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. Epub 2007 Nov 14.
  • Rolke R, Baron R, Maier C, Tölle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Bötefür IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihöfner 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. Erratum in: Pain. 2006 Nov;125(1-2):197.
  • Geber C, Klein T, Azad S, Birklein F, Gierthmühlen J, Huge V, Lauchart M, Nitzsche D, Stengel M, Valet M, Baron R, Maier C, Tölle T, Treede RD. Test-retest and interobserver reliability of quantitative sensory testing according to the protocol of the German Research Network on Neuropathic Pain (DFNS): a multi-centre study. Pain. 2011 Mar;152(3):548-556. doi: 10.1016/j.pain.2010.11.013. Epub 2011 Jan 14.
  • Maier C, Baron R, Tölle TR, Binder A, Birbaumer N, Birklein F, Gierthmühlen J, Flor H, Geber C, Huge V, Krumova EK, Landwehrmeyer GB, Magerl W, Maihöfner C, Richter H, Rolke R, Scherens A, Schwarz A, Sommer C, Tronnier V, Üçeyler N, Valet M, Wasner G, Treede DR. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): somatosensory abnormalities in 1236 patients with different neuropathic pain syndromes. Pain. 2010 Sep;150(3):439-450. doi: 10.1016/j.pain.2010.05.002.
  • Pfau DB, Geber C, Birklein F, Treede RD. Quantitative sensory testing of neuropathic pain patients: potential mechanistic and therapeutic implications. Curr Pain Headache Rep. 2012 Jun;16(3):199-206. doi: 10.1007/s11916-012-0261-3. Review.
  • Ravn P, Frederiksen R, Skovsen AP, Christrup LL, Werner MU. Prediction of pain sensitivity in healthy volunteers. J Pain Res. 2012;5:313-26. doi: 10.2147/JPR.S33925. Epub 2012 Aug 29.
  • Wildgaard K, Ringsted TK, Kehlet H, Werner MU. Quantitative sensory testing in patients with postthoracotomy pain syndrome: Part 2: variability in thermal threshold assessments. Clin J Pain. 2013 Sep;29(9):784-90. doi: 10.1097/AJP.0b013e318277b6ea.
  • Oaklander AL, Romans K, Horasek S, Stocks A, Hauer P, Meyer RA. Unilateral postherpetic neuralgia is associated with bilateral sensory neuron damage. Ann Neurol. 1998 Nov;44(5):789-95.
  • Oaklander AL, Brown JM. Unilateral nerve injury produces bilateral loss of distal innervation. Ann Neurol. 2004 May;55(5):639-44.
  • Petersen KL, Rowbotham MC. Natural history of sensory function after herpes zoster. Pain. 2010 Jul;150(1):83-92. doi: 10.1016/j.pain.2010.04.005. Epub 2010 May 7.
  • Yasuda T, Miki S, Yoshinaga N, Senba E. Effects of amitriptyline and gabapentin on bilateral hyperalgesia observed in an animal model of unilateral axotomy. Pain. 2005 May;115(1-2):161-70.
  • Aasvang EK, Hansen JB, Kehlet H. Pre-operative pain and sensory function in groin hernia. Eur J Pain. 2009 Nov;13(10):1018-22. doi: 10.1016/j.ejpain.2008.11.015. Epub 2009 Jan 14. Erratum in: Eur J Pain. 2016 Nov;20(10 ):1766.
  • Forssell H, Tenovuo O, Silvoniemi P, Jääskeläinen SK. Differences and similarities between atypical facial pain and trigeminal neuropathic pain. Neurology. 2007 Oct 2;69(14):1451-9.
  • Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.
  • Aasvang EK, Kehlet H. Persistent sensory dysfunction in pain-free herniotomy. Acta Anaesthesiol Scand. 2010 Mar;54(3):291-8. doi: 10.1111/j.1399-6576.2009.02137.x. Epub 2009 Oct 15.
  • Kemler 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 25, 2019)
162
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2021
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

INCLUSION CRITERIA:

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):

  • 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)

EXCLUSION CRITERIA:

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
  • 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03966677
Other Study ID Numbers H-16034340
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: https://register.clinicaltrials.gov/prs/app/template/EditProtocol.vm?listmode=Edit&uid=U000190V&ts=15&sid=S0008RBK&cx=-gmj8tv
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Responsible Party mads u werner, University of Copenhagen
Study Sponsor University of Copenhagen
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Copenhagen
Verification Date May 2019