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PROMIS: THE GOOD, THE BAD & THE UNAPPEALING: ABDOMINAL SYMPTOMSMARGARET HEITKEMPERUNIVERSITY OF WASHINGTON
Irritable Bowel Syndrome
• Chronic abdominal pain associated with bowel pattern changes (Rome III criteria)
• Constipation• Diarrhea• Mixed
• 10-17% of US population• Most frequently diagnosed in women• Heterogeneous – range from mild to
severe
PROMIS OVERVIEW
• 2 IBS STUDIES• All incorporated PROMIS measures to look at
biological outcomes– Jarrett – Cain
Irritable Bowel Syndrome
• Questions: Are there biomarkers for symptoms in a functional disorder such as IBS?
• What do the PROMIS© measures tell us?
Irritable Bowel Syndrome
• ANSWER: It depends
PATHWAYS TO ABDOMINAL PAIN
• N = 20 IBS; N = 20 controls• Physiological measures
– Central pain processing– Proteomic/genetic– Inflammatory markers– Videocapsule
PATHWAYS TO ABDOMINAL PAIN
Purpose • Compare conditioned pain modulation (CPM)
in women with IBS to healthy control (HC) women.
• Test relationships of CPM ‘efficiency’ with IBS and psychological symptoms in women with IBS to HC women.
•
8
If a patient be subject to two pains arising in different parts of the body simultaneously, the stronger blunts the other.
Hippocrates’ aphorism (460 – 377 BCE)
Diffuse Noxious Inhibitory Control (DNIC) System
Conditioned Pain Modulation (CPM)
Irritable Bowel Syndrome
Irritable Bowel Syndrome
Experimental Model CPM
Mimic naturally occurring pain inhibiting processes.
How much does the conditioning (noxious) stimulus reduce the pain response evoked by the other noxious stimulus, the test stimulus?
Test stimulus
Conditioning stimulus
10
Cortex
Thalamus
Spinal cord
Caudal Medulla
Peripheral sensory nerve
pain signals 2
1
IBS patients – CPM inefficiency in 3 studies of women
PATHWAYS TO ABDOMINAL PAIN
• 20 IBS; 20 age-matched control women• Pain was rated on verbal numeric pain scale.
12
MethodsRecruited – local community Screening – eligibility
- Women 18 - 45 years - IBS: Diagnosis by HCP, current
symptoms, no other pain disorders- Control group – healthy with no
pain disorders
Visit-1: Written consent, review questionnaires, brief history & physical (NP)
Visit-2: CPM testing in AM during follicular phase (menstrual cycle), 2-week diary of GI and psychological symptoms, stools, medication use
PATHWAYS TO ABDOMINAL PAIN
• 14-DAY DIARY (39 items)– 0 = NOT PRESENT– 1 = MILD– 2 = MODERATE– 3 = SEVERE
• BOWEL DISEASE QUESTIONNAIRE• SCL – 90• IBS – QUALITY OF LIFE (QOL)
PROMIS MEASURES
• Pain interference• Pain behavior
Pathways to Abdominal PainSupported by NINR, NIH
PATHWAYS TO ABDOMINAL PAIN
• Pain Behavior Short Form (PROMIS®)– Common pain behaviors (sighing, crying,), pain
severity behaviors (resting, guarding, facial expressions, asking for help) and verbal reports of pain.
• Pain Interference - Short Form (PROMIS®) – The extent to which pain hinders engagement
with social, cognitive, emotional, physical and recreational activities as well as sleep
Past 7 days
16
CPM Technique
Medoc's PATHWAY Pain & Sensory Evaluation System (Israel)
• Temperatures 0ºC to 55ºC
• Heating and cooling rate up to 8ºC/second
• Thermode 30 X30 mm
• Study maximum thermode temperature 48ºC (118.4 ºF)
17
• Orientation & familiarization Dominant hand 43ºC & 44ºC for 7 sec Rate pain at 6 sec Return 32ºC (90ºF) (baseline)
Rest 5 min
• Pain-6 determination 45ºC, 46ºC, 47ºC, 48ºC Confirm temp at the pain
rating of 6 • Test stimulus• Conditioning stimulus
CPM Protocol
18
• Orientation• Familiarization
Rest 5 min break• Pain-6 temperature determination
Rest 5 min break
• Test stimulus Thermode set to pain-
6 temperature Rate pain at 0, 10, 20,
30 secRest 5 min
• Conditioning stimulus
CPM Technique
19
CPM Technique• Pain rating of test stimulus
during conditioning stimulus Hand in 12ºC water bath for 60 sec. At 10, 20 , 30 sec - rate how painful
sensation is with a hand in the water bath
Thermode is set to Pain-6 level At 40, 50 , 60 sec rate how painful
the sensation is
• CPM Efficiency Pain ratings non-conditioned (test) minus pain ratings conditioned
20
Sample Characteristics HC
(n = 20IBS
(n = 20 P-value
Demographics
Age 27.6 (5.5) 27.4 (6.6) .940
Race, % White 75% 75% 1.00
College Degree 90% 65% .127
Daily symptoms, % days moderate/severe symptoms over 2 wks
Abdominal Pain 4.0 (9.8) 28.0 (22.4) <.001
IBS symptoms 4.9 (11.4) 59.0 (24.2) <.001
Anxiety 1.2 (2.9) 17.0 (20.2) .001
Depressed 0.4 (1.9) 7.5 (13.9) .029
Stressed 6.5 (17.2) 19.3 (20.2) .008
Irritable Bowel Syndrome
PROMIS PAIN©N=20
BEHAVIOR54.1 (8.2)
INTERFERENCE56.8 (7.7)
Daily Diary (14days)
• ABDOMINAL PAIN .428* .416*
• ABD PAIN POST EATING .340 .451*
• ABD DISTENTION .205 .285
RETROSPECTIVE (3m)
• ABDOMINAL PAIN .425* .430*
• WHEN YOU HAD IT – DID IT RESTRICT YOUR ACTIVITIES
.318 .307
QUALITY OF LIFE
• PHYSICAL FX -.502* -.601*
• EMOTIONAL FX -.471* -.300
* P < .1
22
Pain ratings relative to thermode temperature
Note. HC = Healthy Controls. IBS = Irritable Bowel syndrome.Linear regression used to extrapolate high temperatures for some people.
Thermode temperature N HC
(n = 20) N IBS(n = 20)
P-value
45 20 2.16 (1.48) 20 2.85 (2.22) .255
46 20 2.92 (1.75) 20 4.10 (2.13) .063
47 20 4.15 (1.74) 20 5.68 (2.05) .015
48 20 5.54 (2.14) 20 7.11 (2.32) .033
23
CPM efficiency
P < .001 P < .001
24
Scatterplot of CPM with IBS and Psychological Symptoms with Outlier
Correlation of CPM Efficiency with Pain Interference and Pain Behavior
• Pain Behavior (-.31, .17; -.38, .111)• Pain Interference (-.30, -.27, NS)
PATHWAYS TO ABDOMINAL PAIN
• 2nd Study• Comprehensive Self Management• N=86 women with IBS• Baseline Biological Measures
– Genetics– Proteomics– Heart rate variability– Intestinal permeability
27
IBS interference Intensity vs ‘Physiological Group’ in IBS Subjects (n=86)
INTE
NSI
TY –
IBS
Inte
rfer
ence
LOW -- (HRV) -- HIGH
Abdominal Pain in Women with IBS, PMS & Dysmenorrhea
IBS Women with PMS & dysmenorrhea report greater menses-linked amplification of abdominal pain symptoms
Days pre-menses / Days post onset321-1-2-3-4-5-6-7-8-9-10
Mea
n Ab
dom
inal
Pai
n
3.0
2.5
2.0
1.5
1.0
.5
0.0
IBS+Dys+PMSIBS+PMSIBS+Dys
IBS only
Control
Conclusions
• PROMIS MEASURES– GOOD
• Compare to national populations (age, gender)• Compare to other patient populations• Add to data base with similar tools for symptoms• PROMIS PROFILE (29 items)
– BAD• One more tool
– UNAPPEALING• Use of screening?• Vetted by FDA for treatment trial outcomes?• Limited access
Thank you