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Interstitial Cystitis - Elucidation of Psychophysiologic and Autonomic Characteristics (the ICEPAC Study): design and methods.

Chelimsky T, Chelimsky G, McCabe NP, Louttit M, Hijaz A, Mahajan S, Sanses T, Buffington CT, Fenton B, Janicki T, Ialacci S, Veizi E, Zhang D, Daneshgari F, Elston R, Janata J - J Pain Res (2014)

Bottom Line: Interstitial cystitis/bladder pain syndrome (IC/BPS) is relatively common and associated with severe pain, yet effective treatment remains elusive.The study represents a comprehensive, interdisciplinary approach to sampling autonomic and psychophysiologic characteristics of women with IC/BPS.Despite divergent opinions on study methodologies based on specialty experiences, the study has proven feasible to date and different perspectives have proved to be one of the greatest study strengths.

View Article: PubMed Central - PubMed

Affiliation: The Medical College of Wisconsin, Departments of Neurology and Gastroenterology, Milwaukee, WI, USA.

ABSTRACT

Background and purpose: Interstitial cystitis/bladder pain syndrome (IC/BPS) is relatively common and associated with severe pain, yet effective treatment remains elusive. Research typically emphasized the bladder's role, but given the high presence of systemic comorbidities, the authors hypothesized a pathophysiologic nervous system role. This paper reports the methodology and approach to study the nervous system in women with IC/BPS. The study compares neurologic, urologic, gynecologic, autonomic, gastrointestinal, and psychological features of women with IC/BPS, their female relatives, women with myofascial pelvic pain (MPP), and healthy controls to elucidate the role of central and peripheral processing.

Methods and results: In total, 228 women (76 IC/BPS, 76 MPP, 38 family members, and 38 healthy controls) will be recruited. Subjects undergo detailed screening, structured neurologic examination of limbs and pelvis, tender point examination, autonomic testing, electrogastrography, and assessment of comorbid functional dysautonomias. Interpreters are blinded to subject classification. Psychological and stress response characteristics are examined with assessments of stress, trauma history, general psychological function, and stress response quantification. As of December 2012, data collection is completed for 25 healthy controls, 33 IC/BPS ± MPP, eight MPP, and three family members. Recruitment rate is accelerating and strategies emphasize maintaining and encouraging investigator participation in study science, internet advertising, and presentations to pelvic pain support groups.

Conclusion: The study represents a comprehensive, interdisciplinary approach to sampling autonomic and psychophysiologic characteristics of women with IC/BPS. Despite divergent opinions on study methodologies based on specialty experiences, the study has proven feasible to date and different perspectives have proved to be one of the greatest study strengths.

No MeSH data available.


Related in: MedlinePlus

Abdominal exam sites.Notes: Pressure (3 kg) is applied to each site (unless the subject requests the examiner to stop prior to full pressure application). The head is elevated off the examination table in a flexed state during the ten abdominal wall point assessments and relaxed on the table for the remaining six inguinal points and two control points. Measures include the pressure applied at first pain experience (left box), and the pain level (numeric rating scale 0–10, center box) at maximum pressure applied (right box), which may be less than 3 kg if requested by the subject to stop prior to maximum pressure.
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f3-jpr-7-243: Abdominal exam sites.Notes: Pressure (3 kg) is applied to each site (unless the subject requests the examiner to stop prior to full pressure application). The head is elevated off the examination table in a flexed state during the ten abdominal wall point assessments and relaxed on the table for the remaining six inguinal points and two control points. Measures include the pressure applied at first pain experience (left box), and the pain level (numeric rating scale 0–10, center box) at maximum pressure applied (right box), which may be less than 3 kg if requested by the subject to stop prior to maximum pressure.

Mentions: After informed consent, the initial standard medical evaluation includes a medical history, physical exam, pregnancy, and urine dipstick tests. Physical evaluation includes height, weight, lying and standing blood pressure and heart rate, body temperature, and body mass index. An RA leads each visit to ensure direct, in-person contact between clinical and study personnel.21 Once the above information is obtained, a study investigator reviews subject information and performs a routine physical examination of the head, eyes, ears, nose, throat, heart, lungs, extremities, and abdomen and assesses neurologic function. Particular attention is paid to any neurologic findings (eg, neuropathy, Parkinsonian features) that would require exclusion. Next, the RA and study investigator begin the first of several scripted examinations. Figures 3 and 4 show the locations of points examined for tenderness over the abdominal musculature, the inguinal ligaments, adductor muscles, and the pelvic floor musculature. The abdomen, inguinal region, and adductors are examined by applying 3 kg of force using an algometer (Model FDN-50; Wagner Instruments, Greenwich, CT, USA). Both the force associated with the first pain experience and a pain score (NRS: 0–10) at 3 kg (or the maximum tolerated force) are recorded. Pelvic floor muscle examination is done using 2 kg finger pressure where the study investigator standardizes the pressure applied by the digit with the algometer prior to starting the examination. The vulvodynia examination involves moving a lubricated cotton-tipped applicator back and forth inside the vagina (reported as a pressure or pain sensation) followed by a standard six-point assessment of the vulvar mucosa. The subject is oriented to the sensation of pin and cotton on the thigh and asked to determine whether similar contact on the vulva is experienced as pin or cotton and to rank any pain on an NRS of 0–10. A diagnosis of vulvodynia requires three or more points ranked at a pain NRS of four or more. The fibromyalgia examination is conducted per American College of Rheumatology criteria22 using 4 kg of pressure applied by the thumb standardized against the pressure algometer at standard sites. The fibromyalgia examination is conducted at Visit 0 only for healthy controls – as fibromyalgia is exclusionary for healthy controls – and at Visit 2 for IC/BPS, MPP, and family members. The RA records the subject pain ratings and study investigator comments pertaining to the examination. Based on history, examination, and referring physician records, subjects are grouped as IC/BPS ± MPP, MPP alone, or healthy subject. If the subject qualifies for the study, the RA schedules additional study visits and the subject is sent home with a urine hat and 24-hour voiding diary to be completed before her next visit.


Interstitial Cystitis - Elucidation of Psychophysiologic and Autonomic Characteristics (the ICEPAC Study): design and methods.

Chelimsky T, Chelimsky G, McCabe NP, Louttit M, Hijaz A, Mahajan S, Sanses T, Buffington CT, Fenton B, Janicki T, Ialacci S, Veizi E, Zhang D, Daneshgari F, Elston R, Janata J - J Pain Res (2014)

Abdominal exam sites.Notes: Pressure (3 kg) is applied to each site (unless the subject requests the examiner to stop prior to full pressure application). The head is elevated off the examination table in a flexed state during the ten abdominal wall point assessments and relaxed on the table for the remaining six inguinal points and two control points. Measures include the pressure applied at first pain experience (left box), and the pain level (numeric rating scale 0–10, center box) at maximum pressure applied (right box), which may be less than 3 kg if requested by the subject to stop prior to maximum pressure.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4020893&req=5

f3-jpr-7-243: Abdominal exam sites.Notes: Pressure (3 kg) is applied to each site (unless the subject requests the examiner to stop prior to full pressure application). The head is elevated off the examination table in a flexed state during the ten abdominal wall point assessments and relaxed on the table for the remaining six inguinal points and two control points. Measures include the pressure applied at first pain experience (left box), and the pain level (numeric rating scale 0–10, center box) at maximum pressure applied (right box), which may be less than 3 kg if requested by the subject to stop prior to maximum pressure.
Mentions: After informed consent, the initial standard medical evaluation includes a medical history, physical exam, pregnancy, and urine dipstick tests. Physical evaluation includes height, weight, lying and standing blood pressure and heart rate, body temperature, and body mass index. An RA leads each visit to ensure direct, in-person contact between clinical and study personnel.21 Once the above information is obtained, a study investigator reviews subject information and performs a routine physical examination of the head, eyes, ears, nose, throat, heart, lungs, extremities, and abdomen and assesses neurologic function. Particular attention is paid to any neurologic findings (eg, neuropathy, Parkinsonian features) that would require exclusion. Next, the RA and study investigator begin the first of several scripted examinations. Figures 3 and 4 show the locations of points examined for tenderness over the abdominal musculature, the inguinal ligaments, adductor muscles, and the pelvic floor musculature. The abdomen, inguinal region, and adductors are examined by applying 3 kg of force using an algometer (Model FDN-50; Wagner Instruments, Greenwich, CT, USA). Both the force associated with the first pain experience and a pain score (NRS: 0–10) at 3 kg (or the maximum tolerated force) are recorded. Pelvic floor muscle examination is done using 2 kg finger pressure where the study investigator standardizes the pressure applied by the digit with the algometer prior to starting the examination. The vulvodynia examination involves moving a lubricated cotton-tipped applicator back and forth inside the vagina (reported as a pressure or pain sensation) followed by a standard six-point assessment of the vulvar mucosa. The subject is oriented to the sensation of pin and cotton on the thigh and asked to determine whether similar contact on the vulva is experienced as pin or cotton and to rank any pain on an NRS of 0–10. A diagnosis of vulvodynia requires three or more points ranked at a pain NRS of four or more. The fibromyalgia examination is conducted per American College of Rheumatology criteria22 using 4 kg of pressure applied by the thumb standardized against the pressure algometer at standard sites. The fibromyalgia examination is conducted at Visit 0 only for healthy controls – as fibromyalgia is exclusionary for healthy controls – and at Visit 2 for IC/BPS, MPP, and family members. The RA records the subject pain ratings and study investigator comments pertaining to the examination. Based on history, examination, and referring physician records, subjects are grouped as IC/BPS ± MPP, MPP alone, or healthy subject. If the subject qualifies for the study, the RA schedules additional study visits and the subject is sent home with a urine hat and 24-hour voiding diary to be completed before her next visit.

Bottom Line: Interstitial cystitis/bladder pain syndrome (IC/BPS) is relatively common and associated with severe pain, yet effective treatment remains elusive.The study represents a comprehensive, interdisciplinary approach to sampling autonomic and psychophysiologic characteristics of women with IC/BPS.Despite divergent opinions on study methodologies based on specialty experiences, the study has proven feasible to date and different perspectives have proved to be one of the greatest study strengths.

View Article: PubMed Central - PubMed

Affiliation: The Medical College of Wisconsin, Departments of Neurology and Gastroenterology, Milwaukee, WI, USA.

ABSTRACT

Background and purpose: Interstitial cystitis/bladder pain syndrome (IC/BPS) is relatively common and associated with severe pain, yet effective treatment remains elusive. Research typically emphasized the bladder's role, but given the high presence of systemic comorbidities, the authors hypothesized a pathophysiologic nervous system role. This paper reports the methodology and approach to study the nervous system in women with IC/BPS. The study compares neurologic, urologic, gynecologic, autonomic, gastrointestinal, and psychological features of women with IC/BPS, their female relatives, women with myofascial pelvic pain (MPP), and healthy controls to elucidate the role of central and peripheral processing.

Methods and results: In total, 228 women (76 IC/BPS, 76 MPP, 38 family members, and 38 healthy controls) will be recruited. Subjects undergo detailed screening, structured neurologic examination of limbs and pelvis, tender point examination, autonomic testing, electrogastrography, and assessment of comorbid functional dysautonomias. Interpreters are blinded to subject classification. Psychological and stress response characteristics are examined with assessments of stress, trauma history, general psychological function, and stress response quantification. As of December 2012, data collection is completed for 25 healthy controls, 33 IC/BPS ± MPP, eight MPP, and three family members. Recruitment rate is accelerating and strategies emphasize maintaining and encouraging investigator participation in study science, internet advertising, and presentations to pelvic pain support groups.

Conclusion: The study represents a comprehensive, interdisciplinary approach to sampling autonomic and psychophysiologic characteristics of women with IC/BPS. Despite divergent opinions on study methodologies based on specialty experiences, the study has proven feasible to date and different perspectives have proved to be one of the greatest study strengths.

No MeSH data available.


Related in: MedlinePlus