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

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ClinicalTrials.gov Identifier: NCT02748395
Recruitment Status : Withdrawn (No IRB approval)
First Posted : April 22, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Adam Ehrlich, Temple University

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.

Condition or disease Intervention/treatment Phase
Chronic Abdominal Wall Pain Abdominal Cutaneous Nerve Entrapment Syndrome Drug: Triamcinolone Other: Placebo Drug: Lidocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
Study Start Date : May 2016
Estimated Primary Completion Date : December 2016


Arm Intervention/treatment
Placebo Comparator: Placebo
Injection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen
Other: Placebo
Experimental: Treatment
Injection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen
Drug: Triamcinolone
Drug: Lidocaine



Primary Outcome Measures :
  1. Pain score [ Time Frame: Baseline and 1 month ]
    Questionnaire to assess change in pain score


Secondary Outcome Measures :
  1. Pain score [ Time Frame: Baseline and 1 week ]
    Questionnaire to assess change in pain score

  2. Pain score [ Time Frame: Baseline and 2 months ]
    Questionnaire to assess change in pain score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Adam Ehrlich, Assistant Professor of Medicine, Temple University
ClinicalTrials.gov Identifier: NCT02748395     History of Changes
Other Study ID Numbers: 23417
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn
Lidocaine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids