Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
Primary Purpose
Chronic Abdominal Wall Pain, Abdominal Cutaneous Nerve Entrapment Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Triamcinolone
Placebo
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Abdominal Wall Pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Treatment
Arm Description
Injection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen
Injection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen
Outcomes
Primary Outcome Measures
Pain score
Questionnaire to assess change in pain score
Secondary Outcome Measures
Pain score
Questionnaire to assess change in pain score
Pain score
Questionnaire to assess change in pain score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02748395
Brief Title
Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
Official Title
Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No IRB approval
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Abdominal Wall Pain, Abdominal Cutaneous Nerve Entrapment Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Injection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Primary Outcome Measure Information:
Title
Pain score
Description
Questionnaire to assess change in pain score
Time Frame
Baseline and 1 month
Secondary Outcome Measure Information:
Title
Pain score
Description
Questionnaire to assess change in pain score
Time Frame
Baseline and 1 week
Title
Pain score
Description
Questionnaire to assess change in pain score
Time Frame
Baseline and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
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