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

Abdominal Cutaneous Nerve Entrapment Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02748395
• Other study ID #: 23417
• Status: Withdrawn
• Phase: Phase 4
• First received: April 20, 2016
• Last updated: December 2, 2016
• Start date: May 2016

Study information

• Verified date: December 2016
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Cutaneous Nerve Entrapment Syndrome
• Charcot-Marie-Tooth Disease
• Chronic Abdominal Wall Pain
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes

Intervention

Drug:
• Triamcinolone

Other:
• Placebo

Drug:
• Lidocaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Questionnaire to assess change in pain score	Baseline and 1 month	No
Secondary	Pain score	Questionnaire to assess change in pain score	Baseline and 1 week	No
Secondary	Pain score	Questionnaire to assess change in pain score	Baseline and 2 months	No