Clinical trial NCT06121466: Effect of Abdominal Wall Injections on Abdominal Pain
Official title: Effect of Abdominal Wall Injections on Abdominal Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anterior Cutaneous Nerve Entrapment Syndrome
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a prospective cohort study of outpatient adults with chronic abdominal wall pain who receive abdominal wall injections with lidocaine at an academic medical center. Thirty patients will be enrolled. A baseline assessment will include a medical history review and survey administration (Pain Catastrophizing Scale, Psychological Inflexibility in Pain Scale, Patient-Reported Outcomes Measurement Information System-29, Recurrent Abdominal Pain Intensity and Disability scale). Subjects will undergo Quantitative Sensory Testing to measure their pain tolerance and thresholds. The primary outcome to be measured is the change in abdominal wall pain at 1 week, 4 weeks and 12 weeks following the abdominal wall injection, with improvement defined as a 50% reduction in baseline pain score measured using an 11-point numeric scale. Data analysis will consist of basic summary statistics to describe the mean, median, and standard deviation for demographic variables and clinical measures. A one-sample t-test or Wilcoxon test will be used to compare differences in continuous values between time points. Chi-square tests will be used to compare differences in categorical variables. An alpha of 0.05 will be used for all statistical tests. Univariate and multivariate logistic regression will be used to assess for factors associated with pain reduction.

Eligibility criteria: Inclusion Criteria:

* Localized abdominal wall pain
* Average daily pain (7-day recall) ≥ 3 on a scale of 0-10
* Suspected abdominal wall etiology for abdominal pain
* Positive Carnett's sign or pain near an incisional site
* 18 years of age or older

Exclusion Criteria:

* Suspected visceral etiology for the abdominal pain
* Severe allergy to lidocaine
* Unwillingness or inability to provide informed consent
* Low probability of follow-up
* Abdominal wall hernia noted at the point of pain
* History of trigger point injections for abdominal pain
* Bleeding disorder
* Pregnancy, incarceration or decisionally impaired

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: 2) To determine patient characteristics, such as pain catastrophizing, associated with a response to abdominal wall injection
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 2) To determine patient characteristics, within seven health domains, associated with a response to abdominal wall injection
timeFrame: 12 weeks
measure: 2) To determine patient characteristics, such as psychological inflexibility, associated with a response to abdominal wall injection
timeFrame: 12 weeks
measure: 3) To determine the rate of adverse events associated with abdominal wall injection.
timeFrame: 12 weeks
measure: 4) To measure pain thresholds with use of heat, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.
timeFrame: 12 weeks
measure: 4) To measure pain thresholds with use of temporal summation, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.
timeFrame: 12 weeks
measure: 4) To measure pain thresholds with use of pressure thresholds, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References: