Trigger FingerJ-tipNCT02084706

Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection

A study testing Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley, 2% Lidocaine and Triamcinolone (20 g) in people with Trigger Finger, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Jet-injection (J-tip) is a rapid, minimally invasive delivery system that can be used for the subdermal injection of lidocaine solution for anesthetic purposes. The device has been found effective in pain reduction during IV catheterization in adults and children and lumbar puncture in children when compared to… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Trigger Finger
What is being tested?: Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley, 2% Lidocaine and Triamcinolone (20 g)
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients who present to the Hand Clinic at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital, are 18 years of age or older and are indicated for a trigger digit steroid injection will be eligible for participation

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

We believe that administering local anesthetic via J-tip prior to triamcinolone(40 mg/ml) injection could mitigate pain that occurs during and immediately following injection while preserving the post-injection pain relief of anesthetic injection. Furthermore, pre-placement of the jet-injected local anesthetic may obviate the need for the inclusion of local anesthetic into the triamcinolone injection. This would decrease the amount of fluid injected, which could have positive pain modulation by decreased tissue disruption.

Objective: To evaluate the effectiveness of needle free jet injection (J-tip) administration of 2% lidocaine in reduction of the pain experienced during trigger digit 40 mg/ml triamcinolone injection.

Hypothesis: Needle free jet injection (J-tip) administration of 2% lidocaine will prove an equal or superior means of pain reduction when compared to 2% lidocaine injection in the setting of trigger digit triamcinolone injections.

Conditions: Trigger Finger
Being tested: Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley, 2% Lidocaine, Triamcinolone (20 g), J-tip lidocaine administration, Triamcinolone (20 g) Injection over the A1 pulley.
Medical subject headings: Trigger Finger Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulleyProcedure or surgery
2% LidocaineDrug
Triamcinolone (20 g)Drug
J-tip lidocaine administrationProcedure or surgery
Triamcinolone (20 g) Injection over the A1 pulley.Procedure or surgery

Study groups in NCT02084706
Study group	Role	What they receive
Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley	Active comparator	Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley. Receives: Procedure: Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley; Drug: 2% Lidocaine; Drug: Triamcinolone (20 g)
J-tip lidocaine administration, then steroid injection	Experimental	Group two subjects will receive a needle free "J-tip" administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley. Receives: Drug: 2% Lidocaine; Drug: Triamcinolone (20 g); Procedure: J-tip lidocaine administration; Procedure: Triamcinolone (20 g) Injection over the A1 pulley.

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection
Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced.
Measured: Our outcome measure was collected within the 60 seconds before and following the steroid injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Jun 2015

First posted12 Mar 2014 (estimated)
Study startMar 2014
Primary completionMar 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Trigger FingerStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
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 N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02084706
Sponsor's protocol ID: 2013P002370
Acronym: J-tip
Status last verified: Oct 2016
First submitted: 5 Mar 2014
Last updated: 12 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lysakowski C, Dumont L, Tramer MR, Tassonyi E. A needle-free jet-injection system with lidocaine for peripheral intravenous cannula insertion: a randomized controlled trial with cost-effectiveness analysis. Anesth Analg. 2003 Jan;96(1):215-9, table of contents. doi: 10.1097/00000539-200301000-00044.
PubMed 12505955
Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b.
PubMed 22743744
Jimenez N, Bradford H, Seidel KD, Sousa M, Lynn AM. A comparison of a needle-free injection system for local anesthesia versus EMLA for intravenous catheter insertion in the pediatric patient. Anesth Analg. 2006 Feb;102(2):411-4. doi: 10.1213/01.ane.0000194293.10549.62.
PubMed 16428534
Spanos S, Booth R, Koenig H, Sikes K, Gracely E, Kim IK. Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial. Pediatr Emerg Care. 2008 Aug;24(8):511-5. doi: 10.1097/PEC.0b013e31816a8d5b.
PubMed 18645542
Kolind-Sorensen V. Treatment of trigger fingers. Acta Orthop Scand. 1970;41(4):428-32. doi: 10.3109/17453677008991530. No abstract available.
PubMed 5537268
Lapidus PW, Guidotti FP. Stenosing tenovaginitis of the wrist and fingers. Clin Orthop Relat Res. 1972 Mar-Apr;83:87-90. doi: 10.1097/00003086-197203000-00015. No abstract available.
PubMed 5014835
Rhoades CE, Gelberman RH, Manjarris JF. Stenosing tenosynovitis of the fingers and thumb. Results of a prospective trial of steroid injection and splinting. Clin Orthop Relat Res. 1984 Nov;(190):236-8.
PubMed 6488636
Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. doi: 10.1016/S0363-5023(05)80280-1.
PubMed 7594291

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
Functional Disturbance as Result
Recruiting
Low-Level Laser Therapy in the Treatment of Trigger Finger
Trigger Finger, Stenosing Tenosynovitis
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Enrolling by invitation
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
Trigger Finger
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy

All Trigger Finger trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection
ClinicalTrials.gov ID: NCT02084706
Acronym / sponsor ID: J-tip / 2013P002370
Conditions: Trigger Finger
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Study start: Mar 2014
Primary completion: Mar 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 12 Mar 2014 (estimated)
Results: Posted 28 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley	Active comparator	Procedure: Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley, Drug: 2% Lidocaine, Drug: Triamcinolone (20 g)Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.
J-tip lidocaine administration, then steroid injection	Experimental	Drug: 2% Lidocaine, Drug: Triamcinolone (20 g), Procedure: J-tip lidocaine administration, Procedure: Triamcinolone (20 g) Injection over the A1 pulley.Group two subjects will receive a needle free "J-tip" administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who present to the Hand Clinic at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital, are 18 years of age or older and are indicated for a trigger digit steroid injection will be eligible for participation

Key exclusion criteria (0 listed)

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 (20 g) and 2% Lidocaine injection over the A1 pulley	Procedure or surgery	Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley
2% Lidocaine	Drug	J-tip lidocaine administration, then steroid injection, Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley
Triamcinolone (20 g)	Drug	J-tip lidocaine administration, then steroid injection, Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley
J-tip lidocaine administration	Procedure or surgery	J-tip lidocaine administration, then steroid injection
Triamcinolone (20 g) Injection over the A1 pulley.	Procedure or surgery	J-tip lidocaine administration, then steroid injection

Primary outcome

Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection
Time frame: Our outcome measure was collected within the 60 seconds before and following the steroid injection.
Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced.

Results and safety

Results posted to the registry on 28 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley	29	29
J-tip Lidocaine Administration, Then Steroid Injection	31	31

Primary outcome: Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection

Time frame: Our outcome measure was collected within the 60 seconds before and following the steroid injection.. Mean (Standard Deviation). Unit: units on a scale

Measure	Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley n = 29	J-tip Lidocaine Administration, Then Steroid Injection n = 31
Value	1.6 (0.44)	2.8 (0.39)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley	0 of 29 (0%)	0 of 29 (0%)	Not reported
J-tip Lidocaine Administration, Then Steroid Injection	0 of 31 (0%)	0 of 31 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12505955Lysakowski C, Dumont L, Tramer MR, Tassonyi E. A needle-free jet-injection system with lidocaine for peripheral intravenous cannula insertion: a randomized controlled trial with cost-effectiveness analysis. Anesth Analg. 2003 Jan;96(1):215-9, table of contents. doi: 10.1097/00000539-200301000-00044.
Background: PubMed 22743744Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b.
Background: PubMed 16428534Jimenez N, Bradford H, Seidel KD, Sousa M, Lynn AM. A comparison of a needle-free injection system for local anesthesia versus EMLA for intravenous catheter insertion in the pediatric patient. Anesth Analg. 2006 Feb;102(2):411-4. doi: 10.1213/01.ane.0000194293.10549.62.
Background: PubMed 18645542Spanos S, Booth R, Koenig H, Sikes K, Gracely E, Kim IK. Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial. Pediatr Emerg Care. 2008 Aug;24(8):511-5. doi: 10.1097/PEC.0b013e31816a8d5b.
Background: PubMed 5537268Kolind-Sorensen V. Treatment of trigger fingers. Acta Orthop Scand. 1970;41(4):428-32. doi: 10.3109/17453677008991530. No abstract available.
Background: PubMed 5014835Lapidus PW, Guidotti FP. Stenosing tenovaginitis of the wrist and fingers. Clin Orthop Relat Res. 1972 Mar-Apr;83:87-90. doi: 10.1097/00003086-197203000-00015. No abstract available.
Background: PubMed 6488636Rhoades CE, Gelberman RH, Manjarris JF. Stenosing tenosynovitis of the fingers and thumb. Results of a prospective trial of steroid injection and splinting. Clin Orthop Relat Res. 1984 Nov;(190):236-8.
Background: PubMed 7594291Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. doi: 10.1016/S0363-5023(05)80280-1.

Related trials for Trigger Finger

Recruiting
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
Functional Disturbance as Result
Recruiting
Low-Level Laser Therapy in the Treatment of Trigger Finger
Trigger Finger, Stenosing Tenosynovitis
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Enrolling by invitation
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
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RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
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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.

Philip E Blazar, MD principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 0 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: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection (time frame: Our outcome measure was collected within the 60 seconds before and following the steroid injection.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02084706, which also lists 8 linked publications.

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 12 Dec 2016.