Trigger Finger DisorderPhase 4NCT02421419

Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture

A Phase 4 study testing Dexamethasone Sodium Phosphate, Xylocaine and Sodium Chloride in people with Trigger Finger Disorder, run by Kenneth Taylor, M.D. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Trigger Finger Disorder
What is being tested?: Dexamethasone Sodium Phosphate, Xylocaine and Sodium Chloride
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Jun 2015to 25 Jan 2017
Phase: Phase 4
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-90
Male or female (non-pregnant)
Clinically diagnosed trigger digit
Subject is able to provide voluntary, written informed consent
Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.

Who cannot join

Age <18 or >90
Pregnant or lactating women
Non-English speaking individuals
Medication contradictions to lidocaine, corticosteroids and/or saline
Prior injection or surgery on the affected finger
Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS)
Open wound

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Read the detailed description

This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Conditions: Trigger Finger Disorder
Being tested: Dexamethasone Sodium Phosphate, Xylocaine, Sodium Chloride
Keywords: flexor tendon entrapment, snapping finger, trigger digits, trigger thumb
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.

Dexamethasone Sodium PhosphateDrug
Also called Decadron phosphate
adreno-cortical steroid anti-inflammatory drug
XylocaineDrug
Also called Lidocaine HCL
a local anesthetic agent
Sodium ChlorideDrug
Also called Saline
Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment

Study groups in NCT02421419
Study group	Role	What they receive
Corticosteroid alone (CS) Group	Active comparator	1 cc dexamethasone sodium phosphate (4mg/ml) injectable Receives: Drug: Dexamethasone Sodium Phosphate
Corticosteroid/Lidocaine (CSL) Group	Active comparator	1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable Receives: Drug: Dexamethasone Sodium Phosphate; Drug: Xylocaine
Corticosteroid/Saline (CSS) Group	Active comparator	1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline) Receives: Drug: Dexamethasone Sodium Phosphate; Drug: Sodium Chloride

What is being measured

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

VAS
Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).
Measured: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection

Secondary outcomes (3)

Presence of Triggering
Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected.
Measured: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection
Degree of Triggering
A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint.
Measured: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey
Number of Participants With Adverse Effects
Incidence of adverse effects
Measured: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.

Timeline

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

Jun 201525 Jan 2017

First posted20 Apr 2015 (estimated)
Study startJun 2015
Primary completion25 Jan 2017
Study completion25 Jan 2017

Why it stopped: Study closed; recruitment problems

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 (7)Papers the sponsor has linked to this study.
Other trials for Trigger Finger DisorderStudies 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02421419
Sponsor's protocol ID: IRB - 001858
Status last verified: Sep 2018
First submitted: 7 Apr 2015
Last updated: 28 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.
PubMed 11476534
Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
PubMed 269967
Kasdan ML, Leis VM, Lewis K, Kasdan AS. Trigger finger: not always work related. J Ky Med Assoc. 1996 Nov;94(11):498-9.
PubMed 8973080
Marks MR, Gunther SF. Efficacy of cortisone injection in treatment of trigger fingers and thumbs. J Hand Surg Am. 1989 Jul;14(4):722-7. doi: 10.1016/0363-5023(89)90199-8.
PubMed 2754207
Lambert MA, Morton RJ, Sloan JP. Controlled study of the use of local steroid injection in the treatment of trigger finger and thumb. J Hand Surg Br. 1992 Feb;17(1):69-70. doi: 10.1016/0266-7681(92)90014-s.
PubMed 1640148
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
Maneerit J, Sriworakun C, Budhraja N, Nagavajara P. Trigger thumb: results of a prospective randomised study of percutaneous release with steroid injection versus steroid injection alone. J Hand Surg Br. 2003 Dec;28(6):586-9. doi: 10.1016/s0266-7681(03)00172-4.
PubMed 14599834

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

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Low-Level Laser Therapy in the Treatment of Trigger Finger
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Not yet recruiting
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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
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Osteoarthritis, Tendinopathy

All Trigger Finger Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture
ClinicalTrials.gov ID: NCT02421419
Acronym / sponsor ID: IRB - 001858
Conditions: Trigger Finger Disorder
Keywords: flexor tendon entrapment, snapping finger, trigger digits, trigger thumb
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study closed; recruitment problems
Enrolment: 26 participants (actual)
Lead sponsor: Kenneth Taylor, M.D.University, hospital or other
Study start: Jun 2015
Primary completion: 25 Jan 2017 (actual)
Study completion: 25 Jan 2017 (actual)
First posted: 20 Apr 2015 (estimated)
Results: Posted 23 Jan 2018

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Corticosteroid alone (CS) Group	Active comparator	Drug: Dexamethasone Sodium Phosphate1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Corticosteroid/Lidocaine (CSL) Group	Active comparator	Drug: Dexamethasone Sodium Phosphate, Drug: Xylocaine1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Corticosteroid/Saline (CSS) Group	Active comparator	Drug: Dexamethasone Sodium Phosphate, Drug: Sodium Chloride1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18-90
Male or female (non-pregnant)
Clinically diagnosed trigger digit
Subject is able to provide voluntary, written informed consent
Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.

Key exclusion criteria (7 listed)

Age <18 or >90
Pregnant or lactating women
Non-English speaking individuals
Medication contradictions to lidocaine, corticosteroids and/or saline
Prior injection or surgery on the affected finger

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
Dexamethasone Sodium PhosphateAlso: Decadron phosphateadreno-cortical steroid anti-inflammatory drug	Drug	Corticosteroid alone (CS) Group, Corticosteroid/Lidocaine (CSL) Group, Corticosteroid/Saline (CSS) Group
XylocaineAlso: Lidocaine HCLa local anesthetic agent	Drug	Corticosteroid/Lidocaine (CSL) Group
Sodium ChlorideAlso: SalineSodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment	Drug	Corticosteroid/Saline (CSS) Group

Primary outcome

VAS
Time frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection
Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).

3 secondary outcomes

Presence of Triggering
Time frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection
Degree of Triggering
Time frame: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey
Number of Participants With Adverse Effects
Time frame: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.

Results and safety

Results posted to the registry on 23 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Corticosteroid Alone (CS) Group	6	6
Corticosteroid/Lidocaine (CSL) Group	11	11
Corticosteroid/Saline (CSS) Group	9	8

Primary outcome: VAS

Time frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection. Mean (Standard Deviation). Unit: units on a scale

Measure	Corticosteroid Alone (CS) Group n = 6	Corticosteroid/Lidocaine (CSL) Group n = 11	Corticosteroid/Saline (CSS) Group n = 8
VAS pre-injection	2.2 (1.0)	3.0 (2.5)	3.9 (2.9)
VAS 1 minute post-injection	2.3 (1.2)	2.2 (2.6)	4.9 (3.4)
VAS 10 minutes post-injection	2.1 (2.3)	1.2 (1.7)	3.3 (2.8)
VAS 6 weeks post-injection	1.5 (1.6)	3.3 (3.7)	4.0 (3.8)
VAS Recollection	5.2 (2.3)	6.6 (2.5)	5.9 (3.6)

Population analysed: VAS was collected on all study participants except for the one patient (CSS group) who was withdrawn after enrollment and before any measurements were taken.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse effects were assessed 1 minute, 10 minutes, and 6 weeks post-injction. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Corticosteroid Alone (CS) Group	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Corticosteroid/Lidocaine (CSL) Group	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Corticosteroid/Saline (CSS) Group	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): Study closed prematurely on 1/25/2017 with 26 patients enrolled and 1 withdrawal.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11476534Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.
Background: PubMed 269967Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
Background: PubMed 8973080Kasdan ML, Leis VM, Lewis K, Kasdan AS. Trigger finger: not always work related. J Ky Med Assoc. 1996 Nov;94(11):498-9.
Background: PubMed 2754207Marks MR, Gunther SF. Efficacy of cortisone injection in treatment of trigger fingers and thumbs. J Hand Surg Am. 1989 Jul;14(4):722-7. doi: 10.1016/0363-5023(89)90199-8.
Background: PubMed 1640148Lambert MA, Morton RJ, Sloan JP. Controlled study of the use of local steroid injection in the treatment of trigger finger and thumb. J Hand Surg Br. 1992 Feb;17(1):69-70. doi: 10.1016/0266-7681(92)90014-s.
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.
Background: PubMed 14599834Maneerit J, Sriworakun C, Budhraja N, Nagavajara P. Trigger thumb: results of a prospective randomised study of percutaneous release with steroid injection versus steroid injection alone. J Hand Surg Br. 2003 Dec;28(6):586-9. doi: 10.1016/s0266-7681(03)00172-4.
Individual participant dataSharing planned: No

Related trials for Trigger Finger Disorder

Recruiting
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
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Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
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Enrolling by invitation
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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.

Kenneth Taylor, MD principal investigator

Milton S. Hershey Medical Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone Sodium Phosphate, Xylocaine and Sodium Chloride in people with Trigger Finger Disorder, run by Kenneth Taylor, M.D. at 1 site in United States.

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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Sep 2018. 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.

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?

Yes. Results are posted in the registry (first posted 23 Jan 2018). 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?

VAS (time frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-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 NCT02421419, which also lists 7 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 28 Sep 2018.