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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Withdrawn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
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Abdominal Wall Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 20, 2016
    Last Updated
    December 2, 2016
    Sponsor
    Temple University
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    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

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