Trigger FingerNCT01886157
Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting
A study testing Corticosteroid injection + Trigger Splint+ Education and Home exercises and Corticosteroid injection in people with Trigger Finger and Stenosing Tenosynovitis, run by The Philadelphia & South Jersey Hand Center at 1 site in United States.
Trial summary
Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger, Stenosing Tenosynovitis
- What is being tested?
- Corticosteroid injection + Trigger Splint+ Education and Home exercises and Corticosteroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2016
- Phase
- Interventional
- 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
- Trigger finger in one or more trigger fingers, in stages 2 to 5 (inclusive)
- Adult patient aged over 18 years.
- No prior treatment (splinting, injection or surgery) to the involved finger OR at least 1 year since last treatment of the involved finger.
Who cannot join
- Exclude Trigger thumbs because they appear to be respond very favorably or unfavorably to treatment3
- Exclude locked digits because surgery is indicated in these cases
- Pregnant patients
- Prisoners
- Patients with impaired decision-making capacity
- Patients that do not speak English and cannot fill in English language questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Philadelphia and South Jersey Hand Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial
Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone.
Read the detailed description
Stenosing tenosynovitis, or more commonly "trigger finger" is a disease that can severely impact a patient's quality of life. Its incidence is said to be 28 persons per 100,000 annually. The disease is manifested in one or more fingers by finger locking in flexion or extension, leading to pain, discomfort and at times, loss of function. Patients frequently report having to snap their fingers back in position to alleviate symptoms. The pathophysiology relates to thickening of the flexor tendon sheath, which can impair tendon gliding within it.
Although multiple treatment strategies are available, it is not entirely clear which treatment offers the best outcome, especially when the finger has not reached end stage locking. In general, corticosteroid injection into the tendon sheath is offered as the first line of treatment. Splinting alone has also been described as a reliable method treatment. However, Patel and Bassini indicated that steroid injection results in fewer recurrences than splinting alone. Surgery is typically reserved for recurrent triggering, cases refractory to injection, or digits locked in flexion. The effects of steroid injection followed by splinting however have not been reported in a comprehensive fashion. It may be that this form of treatment could result in a synergistic effect, which can offer a treatment modality superior to either injection or splinting alone. The purpose of this research study is to determine whether steroid injection followed by splinting is superior to injection alone.
- Conditions
- Trigger Finger, Stenosing Tenosynovitis
- Being tested
- Corticosteroid injection + Trigger Splint+ Education and Home exercises, Corticosteroid injection
- Keywords
- trigger finger, orthotic intervention
- Medical subject headings
- Trigger Finger Disorder, Tendon Entrapment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injection + Trigger Splint+ Education and Home exercisesProcedure or surgery
Standard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises.
Corticosteroid injectionProcedure or surgery
Standard trigger finger corticosteroid injection.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid injection | Active comparator | Standard corticosteroid injection. Receives: Procedure: Corticosteroid injection |
| Corticosteroid Injection and Trigger Splint | Experimental | Corticosteroid Injection + Trigger Splint + Education + Home Exercises Receives: Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of finger triggering
Trigger Finger Stage:
- Normal
- Painful palpable nodule
- Triggering = Clicking = Catching
- Locking of finger in flexion or extension unlocked by active finger movement
- Locking of finger in flexion or extension unlocked by passive finger movement
- Locked finger in flexion or extension (Each stage may be painless or painful)
Measured: 1, 2, 4-6, and 12 months
Secondary outcomes (3)
Failed treatment: surgical intervention required
Failed treatment OR Successful treatment
Measured: 1,2, 4-6, 12months
Patient rated functional outcome
Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale
Measured: 1, 2, 4-6, 12months
Pain
Visual Analog Scale
Measured: 1, 2, 4-6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trigger FingerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Philadelphia & South Jersey Hand Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidney M. Jacoby, The Philadelphia & South Jersey Hand Center
- Investigators
- Sidney Jacoby, MD, Study director, The Philadelphia and South Jersey Hand Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886157
- Sponsor's protocol ID
- 11C.554
- Status last verified
- Mar 2015
- First submitted
- 21 Jun 2013
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ring D, Lozano-Calderon S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand Surg Am. 2008 Apr;33(4):516-22; discussion 523-4. doi: 10.1016/j.jhsa.2008.01.001.
PubMed 18406955Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
PubMed 269967Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22.
PubMed 19006759Patel MR, Bassini L. Trigger fingers and thumb: when to splint, inject, or operate. J Hand Surg Am. 1992 Jan;17(1):110-3. doi: 10.1016/0363-5023(92)90124-8.
PubMed 1538090
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01886157
- Acronym / sponsor ID
- 11C.554
- Conditions
- Trigger Finger, Stenosing Tenosynovitis
- Keywords
- trigger finger, orthotic intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Philadelphia & South Jersey Hand CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 25 Jun 2013 (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.
Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone.
Detailed description
Stenosing tenosynovitis, or more commonly "trigger finger" is a disease that can severely impact a patient's quality of life. Its incidence is said to be 28 persons per 100,000 annually. The disease is manifested in one or more fingers by finger locking in flexion or extension, leading to pain, discomfort and at times, loss of function. Patients frequently report having to snap their fingers back in position to alleviate symptoms. The pathophysiology relates to thickening of the flexor tendon sheath, which can impair tendon gliding within it.
Although multiple treatment strategies are available, it is not entirely clear which treatment offers the best outcome, especially when the finger has not reached end stage locking. In general, corticosteroid injection into the tendon sheath is offered as the first line of treatment. Splinting alone has also been described as a reliable method treatment. However, Patel and Bassini indicated that steroid injection results in fewer recurrences than splinting alone. Surgery is typically reserved for recurrent triggering, cases refractory to injection, or digits locked in flexion. The effects of steroid injection followed by splinting however have not been reported in a comprehensive fashion. It may be that this form of treatment could result in a synergistic effect, which can offer a treatment modality superior to either injection or splinting alone. The purpose of this research study is to determine whether steroid injection followed by splinting is superior to injection alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid injection | Active comparator | Procedure: Corticosteroid injectionStandard corticosteroid injection. |
| Corticosteroid Injection and Trigger Splint | Experimental | Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercisesCorticosteroid Injection + Trigger Splint + Education + Home Exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Trigger finger in one or more trigger fingers, in stages 2 to 5 (inclusive)
- Adult patient aged over 18 years.
- No prior treatment (splinting, injection or surgery) to the involved finger OR at least 1 year since last treatment of the involved finger.
Key exclusion criteria (6 listed)
- Exclude Trigger thumbs because they appear to be respond very favorably or unfavorably to treatment3
- Exclude locked digits because surgery is indicated in these cases
- Pregnant patients
- Prisoners
- Patients with impaired decision-making capacity
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 |
|---|---|---|
| Corticosteroid injection + Trigger Splint+ Education and Home exercisesStandard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises. | Procedure or surgery | Corticosteroid Injection and Trigger Splint |
| Corticosteroid injectionStandard trigger finger corticosteroid injection. | Procedure or surgery | Corticosteroid injection |
Primary outcome
Stage of finger triggering
Time frame: 1, 2, 4-6, and 12 months
Trigger Finger Stage: 1. Normal 2. Painful palpable nodule 3. Triggering = Clicking = Catching 4. Locking of finger in flexion or extension unlocked by active finger movement 5. Locking of finger in flexion or extension unlocked by passive finger movement 6. Locked finger in flexion or extension (Each stage may be painless or painful)
3 secondary outcomes
Failed treatment: surgical intervention required
Time frame: 1,2, 4-6, 12months
Patient rated functional outcome
Time frame: 1, 2, 4-6, 12months
Pain
Time frame: 1, 2, 4-6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Background: PubMed 18406955Ring D, Lozano-Calderon S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand Surg Am. 2008 Apr;33(4):516-22; discussion 523-4. doi: 10.1016/j.jhsa.2008.01.001.
- Results publication: PubMed 269967Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.
- Results publication: PubMed 19006759Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22.
- Results publication: PubMed 1538090Patel MR, Bassini L. Trigger fingers and thumb: when to splint, inject, or operate. J Hand Surg Am. 1992 Jan;17(1):110-3. doi: 10.1016/0363-5023(92)90124-8.
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
Trigger Finger
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
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.
Sidney Jacoby, MD study director
The Philadelphia and South Jersey Hand Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid injection + Trigger Splint+ Education and Home exercises and Corticosteroid injection in people with Trigger Finger and Stenosing Tenosynovitis, run by The Philadelphia & South Jersey Hand Center 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. 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?
Results are not available in the source record.
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?
Stage of finger triggering (time frame: 1, 2, 4-6, and 12 months). 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 NCT01886157, which also lists 4 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 18 Mar 2015.