Chronic Abdominal Wall PainPhase 4NCT02748395
Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
A Phase 4 study testing Triamcinolone and Lidocaine in people with Chronic Abdominal Wall Pain and Abdominal Cutaneous Nerve Entrapment Syndrome, run by Temple University.
Trial summary
The purpose of this study is to determine whether the injection of triamcinolone and lidocaine is effective in relieving chronic abdominal wall pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Abdominal Wall Pain, Abdominal Cutaneous Nerve Entrapment Syndrome
- What is being tested?
- Triamcinolone and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Multiple trigger points
- Abdominal wall hernia on exam
- Weight loss
- Rectal bleeding
- Recent change in bowel habits
- Decompensated cirrhosis or recurrent ascites
Show all 11Show fewer
- 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
About this study
The purpose of this study is to determine whether the injection of triamcinolone and lidocaine is effective in relieving chronic abdominal wall pain.
- Being tested
- Triamcinolone, Placebo, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
PlaceboOther
LidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Injection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen Receives: Other: Placebo |
| Treatment | Experimental | Injection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen Receives: Drug: Triamcinolone; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Questionnaire to assess change in pain score
Measured: Baseline and 1 month
Secondary outcomes (2)
Pain score
Questionnaire to assess change in pain score
Measured: Baseline and 1 week
Pain score
Questionnaire to assess change in pain score
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
Why it stopped: No IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Abdominal Wall PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Ehrlich, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748395
- Sponsor's protocol ID
- 23417
- Status last verified
- Dec 2016
- First submitted
- 20 Apr 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
- ClinicalTrials.gov ID
- NCT02748395
- Acronym / sponsor ID
- 23417
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the injection of triamcinolone and lidocaine is effective in relieving chronic abdominal wall pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboInjection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen |
| Treatment | Experimental | Drug: Triamcinolone, Drug: LidocaineInjection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Multiple trigger points
- Abdominal wall hernia on exam
- Weight loss
- Rectal bleeding
- Recent change in bowel habits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone | Drug | Treatment |
| Placebo | Other | Placebo |
| Lidocaine | Drug | Treatment |
Primary outcome
Pain score
Time frame: Baseline and 1 month
Questionnaire to assess change in pain score
2 secondary outcomes
Pain score
Time frame: Baseline and 1 week
Pain score
Time frame: Baseline and 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone and Lidocaine in people with Chronic Abdominal Wall Pain and Abdominal Cutaneous Nerve Entrapment Syndrome, run by Temple University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.