- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02748395
Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
December 2, 2016 updated by: Adam Ehrlich, Temple University
The purpose of this study is to determine whether the injection of triamcinolone and lidocaine is effective in relieving chronic abdominal wall pain.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Injection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen
|
|
EXPERIMENTAL: Treatment
Injection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: Baseline and 1 month
|
Questionnaire to assess change in pain score
|
Baseline and 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: Baseline and 1 week
|
Questionnaire to assess change in pain score
|
Baseline and 1 week
|
Pain score
Time Frame: Baseline and 2 months
|
Questionnaire to assess change in pain score
|
Baseline and 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (ANTICIPATED)
December 1, 2016
Study Registration Dates
First Submitted
April 20, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (ESTIMATE)
April 22, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
December 5, 2016
Last Update Submitted That Met QC Criteria
December 2, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Peripheral Nervous System Diseases
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Nerve Compression Syndromes
- Charcot-Marie-Tooth Disease
- Hereditary Sensory and Motor Neuropathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Triamcinolone
Other Study ID Numbers
- 23417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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