NCT06121466|RecruitingPhase 4FDA Drug
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Sponsor study identifier
interventional
45
1 country
2
Study Start
January 1, 2023
Actual (reported)Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a prospective cohort study of outpatient adults with chronic abdominal wall pain receiving abdominal wall injections, as part of their usual care, with lidocaine. Subjects will be recruited at the outpatient gastroenterology clinic at OHSU.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2023
Actual (reported)September 6, 2023
Actual (reported)November 8, 2023
Actual (reported)December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
1) To measure the change in abdominal wall pain 1-week, 1-month and 3-months following abdominal wall injections, with improvement defined as a 50% reduction in baseline pain score measured using an 11-point numeric scale.
Improvement is defined as a 50% reduction in baseline pain score measured using an 11-point numeric scale where 0 is no pain and 10 is the worst pain the patient has every felt.
12 weeks
2) To determine patient characteristics, such as pain catastrophizing, associated with a response to abdominal wall injection
This will be measured by the following: Pain Catastrophizing Scale (PCS): Each question is rated on a scale of 0 to 4, where 0 is no catastrophizing, and 4 is significant catastrophizing.
12 weeks
2) To determine patient characteristics, such as patient reported functional status, pain status, and global estimate status; associated with a response to abdominal wall injection
This will be measured by the following: Routine Assessment of Patient Index Data (RAPID) Questionnaire: Assessing patient-reported measures of function, pain, and patient global estimate status. First set of items are rated on a 4-point scale, ranging from 0 to 3, where higher scores indicate lower functioning. Second set of items are rated on a scale from 0 to 10 where the higher the number the more pain the person is experiencing. The third set is rated on a scale from 0 to 10 where 10 is the poorest overall status.
12 weeks
2) To determine patient characteristics, within seven health domains, associated with a response to abdominal wall injection
Patients with abdominal pain who are suspected of having abdominal wall pain.
Injections will be administered for patient who are identified as having abdominal wall pain.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
OHSU
Portland, Oregon, 97239, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
First Submitted
September 6, 2023
First Posted
November 8, 2023
Study Start
January 1, 2023
Actual (reported)Primary Completion
December 2025
Estimated (date passed)This will be measured by the following: Patient-Reported Outcomes Measurement Information System-29 Scale: Assessing pain intensity using a single 0-10 numeric rating (0 is no pain, 10 is the worst pain ever felt) item and seven health domains.
12 weeks
2) To determine patient characteristics, such as psychological inflexibility, associated with a response to abdominal wall injection
Psychological Inflexibility in Pain Scale: Items are rated on a 7-point scale, ranging from 1 to 7, where higher scores indicate greater levels of psychological inflexibility.
12 weeks
3) To determine the rate of adverse events associated with abdominal wall injection.
Adverse events associated with abdominal wall injections include pain or discoloration at the injection site, a syncopal episode after the injection, allergic reaction to lidocaine or alcohol swab/chloroprep. There is a rare risk for seizures and injury to a muscle.
12 weeks
4) To measure pain thresholds with use of heat, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.
This will be measured by the following: Heat Pain Threshold and Pain Tolerance :. This task involves applying a series of heat sensations using a heat thermode (TSA-II Air, Medoc) to the subject's dominant inner forearm.
12 weeks
4) To measure pain thresholds with use of temporal summation, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.
This will be measured by the following: Temporal summation. For assessment of temporal summation (TS), punctate mechanical stimuli will be delivered to the dorsal surface of the dominant hand using a 300-gm nylon monofilament developed by the German Research Network on Neuropathic Pain.
12 weeks
4) To measure pain thresholds with use of pressure thresholds, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.
This will be measured by the following: Pressure pain threshold. Pressure pain threshold (PPTh) will be assessed via an algometer using pressure pain stimuli delivered to dorsal forearm (distal stimuli) and the trapezius (order counterbalanced).
12 weeks
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 2, 2025
Record last verified: 2025-08
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