NCT02748395

Brief Summary

The purpose of this study is to determine whether the injection of triamcinolone and lidocaine is effective in relieving chronic abdominal wall pain.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

April 20, 2016

Last Update Submit

December 2, 2016

Conditions

Chronic Abdominal Wall PainAbdominal Cutaneous Nerve Entrapment Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Questionnaire to assess change in pain score

    Baseline and 1 month

Secondary Outcomes (2)

  • Pain score

    Baseline and 1 week

  • Pain score

    Baseline and 2 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Injection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen

Other: Placebo

Treatment

EXPERIMENTAL

Injection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen

Drug: TriamcinoloneDrug: Lidocaine

Interventions

TriamcinoloneDRUG
Treatment
PlaceboOTHER
Placebo
LidocaineDRUG
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic abdominal wall pain
  • Prior ultrasound or cross-sectional imaging of the abdomen to exclude other causes
  • Baseline Brief Pain Inventory score ≥ 5

You may not qualify if:

  • Multiple trigger points
  • Abdominal wall hernia on exam
  • Weight loss
  • Rectal bleeding
  • Recent change in bowel habits
  • Decompensated cirrhosis or recurrent ascites
  • Allergy or contraindication to study medications
  • Known thrombocytopenia with platelet count \< 50,000
  • Other diagnosis of chronic pain syndromes including fibromyalgia
  • Unable to provide informed consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

TriamcinoloneLidocaine

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 22, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Last Updated

December 5, 2016

Record last verified: 2016-12