Lidocaine and Triamcinolone vs Saline Trigger Point Injec... | NCT02748395

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

NCT02748395

Sponsor

Temple University

Status

Withdrawn

Last Update Posted

Dec 5, 2016Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Chronic Abdominal Wall Pain
Abdominal Cutaneous Nerve Entrapment Syndrome

Interventions

Triamcinolone
Placebo
Lidocaine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No IRB approval

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 20, 2016

First Submission Date that Met QC Criteria

Apr 21, 2016

First Posted Date

Apr 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2016

Last Update Posted Date

Dec 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triamcinolone	Drug		Treatment
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score	Questionnaire to assess change in pain score	Baseline and 1 month

Secondary Outcomes

Measure	Description	Time Frame
Pain score	Questionnaire to assess change in pain score	Baseline and 1 week
Pain score	Questionnaire to assess change in pain score

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014221	Triamcinolone
D008012	Lidocaine

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided