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Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain

NCT ID: NCT02748395

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Abdominal Wall Pain Abdominal Cutaneous Nerve Entrapment Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Treatment

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

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Interventions

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Triamcinolone

Intervention Type DRUG

Placebo

Intervention Type OTHER

Lidocaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Adam Ehrlich

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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23417

Identifier Type: -

Identifier Source: org_study_id