Trigger FingerNCT03847935
Trigger Finger Treatment
An observational study of Trigger Finger and Trigger Digit, run by University of Massachusetts, Lowell.
Trial summary
Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness and/or snapping during movement. This observational study compared all of the possible treatments and combinations of treatments for trigger finger at the A1 pulley, including surgery, cortisone injections and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger, Trigger Digit, Stenosing Tenosynovitis
- What is being tested?
- surgery, corticosteroid injections and Hand Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2007to 8 Dec 2012
- Phase
- Observational
- 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
Study population: patients undergoing medical treatment or hand therapy for trigger finger in digits #2-5 at the hand clinic. Patients were dropped from the study if they had changed to a different treatment.
Who may be able to join
- trigger finger in digit 2-5
Who cannot join
- if prior treatment for trigger finger, or Trigger thumb
About this study
Official title: Trigger Finger Treatment - An Outcomes Study. Comparing 6 Traditional Treatment Techniques
Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness and/or snapping during movement. This observational study compared all of the possible treatments and combinations of treatments for trigger finger at the A1 pulley, including surgery, cortisone injections and hand therapy.
Read the detailed description
Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness or snapping during movement. This can be very debilitating. Current treatment includes local steroid injection, oral NSAIDS, resting orthoses, physical or occupational therapy and surgical intervention. The aim of this prospective study with an observational design was to determine the outcome between surgical, hand therapy rehabilitation, and corticosteroid injection interventions for trigger finger. There were 6 treatment groups: surgery, corticosteroid injection, 1 visit of hand therapy for orthosis fabrication and therapeutic exercise, hand therapy in combination with cortisone injection, Modality hand therapy alone (ongoing visits) or with corticosteroid injections.
- Conditions
- Trigger Finger, Trigger Digit, Stenosing Tenosynovitis
- Being tested
- surgery, corticosteroid injections, Hand Therapy, Modality Hand Therapy
- Keywords
- treatment outcome, hand therapy, physical therapy, occupational therapy
- 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.
surgeryProcedure or surgery
A1 pulley release of finger
corticosteroid injectionsProcedure or surgery
corticosteroid injection to A1 pulley
Hand TherapyOther
Also called physical therapy, occupational therapy
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,
Modality Hand TherapyOther
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Patients who underwent surgical release of A1 pulley Receives: Procedure: surgery | |
| corticosteroid injections only | Patients who underwent local corticosteroid injections only, and no other treatment Receives: Procedure: corticosteroid injections | |
| hand therapy only occupational/physical | 1 visit: orthosis fabrication, range of motion, nodule and ice massage. Receives: Other: Hand Therapy | |
| Injection and Hand therapy | This group of participants received a combination of corticosteroid injection in the affected finger and one visit of hand therapy. Receives: Procedure: corticosteroid injections; Other: Hand Therapy | |
| Modality Hand Therapy | Ongoing hand therapy treatment, which included the above plus modalities such as ultrasound or iontophoresis. Receives: Other: Modality Hand Therapy | |
| Injection and Modality Hand Therapy | Ccombination of local cortiscosteroid injection to the affected digit and ongoing hand therapy with modalities. Receives: Procedure: corticosteroid injections; Other: Modality Hand Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional use using Quick DASH 6 weeks
Change from baseline to 6 weeks Quick DASH
Measured: Day 1, 6 weeks
Change in Functional use using Quick DASH 3 months
Change from baseline to 3 months Quick DASH
Measured: Day 1, 3 months
Change in Functional use using Quick DASH 6 months
Change from baseline to 6 months Quick DASH
Measured: Day 1, 6 months
Change in Edema 6 weeks
Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx
Measured: day 1, 6 weeks
Change in Edema 3 months
Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx
Measured: day 1, 3 months
Change in Edema 6 months
Baseline to 6 months weeks Circumferential measurement in centimeters of the proximal phalanx
Measured: day 1, 6 months
Change in Pain on a likert scale 6 weeks
Baseline to 6 weeks pain on a 0-10 scale
Measured: 1 day, 6 weeks
Change in Pain on a likert scale 3 months
Baseline to 3 months pain on a 0-10 scale
Measured: 1 day, 3 months
Change in Pain on a likert scale 6 months
Baseline to 6 months pain on a 0-10 scale
Measured: 1 day, 6 months
Change in Range of motion 6 weeks
Baseline to 6 weeks flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
Measured: 1 day, 6 weeks
Change in Range of motion 3 months
Baseline to 3 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
Measured: 1 day, 3 months
Change in Range of motion 6 months
Baseline to 6 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
Measured: 1 day, 6 months
Change in Severity or Grade of triggering 6 weeks
Baseline to 6 weeks Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
Measured: 1 day, 6 weeks
Change in Severity or Grade of triggering 3 months
Baseline to 3 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
Measured: 1 day, 3 months
Change in Severity or Grade of triggering 6 months
Baseline to 6 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
Measured: 1 day, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start10 Dec 2007
- Primary completion8 Dec 2012
- Study completion8 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Lowell
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Principal investigator, ELewis, University of Massachusetts, Lowell
- Investigators
- Erika S. Lewis, Ed.D, Principal investigator, Associate Professor, University of Massachusetts Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847935
- Sponsor's protocol ID
- H-12583
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans for sharing the IPD
Publications
Lewis E, Fors L, Tharion WJ. Interrater and intrarater reliability of finger goniometric measurements. Am J Occup Ther. 2010 Jul-Aug;64(4):555-61. doi: 10.5014/ajot.2010.09028.
PubMed 20825126
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Finger Treatment - An Outcomes Study. Comparing 6 Traditional Treatment Techniques
- ClinicalTrials.gov ID
- NCT03847935
- Acronym / sponsor ID
- H-12583
- Conditions
- Trigger Finger, Trigger Digit, Stenosing Tenosynovitis
- Keywords
- treatment outcome, hand therapy, physical therapy, occupational therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Massachusetts, LowellUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- 10 Dec 2007 (actual)
- Primary completion
- 8 Dec 2012 (actual)
- Study completion
- 8 Dec 2012 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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.
Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness and/or snapping during movement. This observational study compared all of the possible treatments and combinations of treatments for trigger finger at the A1 pulley, including surgery, cortisone injections and hand therapy.
Detailed description
Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness or snapping during movement. This can be very debilitating. Current treatment includes local steroid injection, oral NSAIDS, resting orthoses, physical or occupational therapy and surgical intervention. The aim of this prospective study with an observational design was to determine the outcome between surgical, hand therapy rehabilitation, and corticosteroid injection interventions for trigger finger. There were 6 treatment groups: surgery, corticosteroid injection, 1 visit of hand therapy for orthosis fabrication and therapeutic exercise, hand therapy in combination with cortisone injection, Modality hand therapy alone (ongoing visits) or with corticosteroid injections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: surgeryPatients who underwent surgical release of A1 pulley |
| corticosteroid injections only | – | Procedure: corticosteroid injectionsPatients who underwent local corticosteroid injections only, and no other treatment |
| hand therapy only occupational/physical | – | Other: Hand Therapy1 visit: orthosis fabrication, range of motion, nodule and ice massage. |
| Injection and Hand therapy | – | Procedure: corticosteroid injections, Other: Hand TherapyThis group of participants received a combination of corticosteroid injection in the affected finger and one visit of hand therapy. |
| Modality Hand Therapy | – | Other: Modality Hand TherapyOngoing hand therapy treatment, which included the above plus modalities such as ultrasound or iontophoresis. |
| Injection and Modality Hand Therapy | – | Procedure: corticosteroid injections, Other: Modality Hand TherapyCcombination of local cortiscosteroid injection to the affected digit and ongoing hand therapy with modalities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing medical treatment or hand therapy for trigger finger in digits #2-5 at the hand clinic. Patients were dropped from the study if they had changed to a different treatment.
Key inclusion criteria (1 listed)
- trigger finger in digit 2-5
Key exclusion criteria (1 listed)
- if prior treatment for trigger finger, or Trigger thumb
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 |
|---|---|---|
| surgeryA1 pulley release of finger | Procedure or surgery | Surgery |
| corticosteroid injectionscorticosteroid injection to A1 pulley | Procedure or surgery | Injection and Hand therapy, Injection and Modality Hand Therapy, corticosteroid injections only |
| Hand TherapyAlso: physical therapy, occupational therapyorthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, | Other | Injection and Hand therapy, hand therapy only occupational/physical |
| Modality Hand Therapyorthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis | Other | Injection and Modality Hand Therapy, Modality Hand Therapy |
Primary outcome
Change in Functional use using Quick DASH 6 weeks
Time frame: Day 1, 6 weeks
Change from baseline to 6 weeks Quick DASH
Change in Functional use using Quick DASH 3 months
Time frame: Day 1, 3 months
Change from baseline to 3 months Quick DASH
Change in Functional use using Quick DASH 6 months
Time frame: Day 1, 6 months
Change from baseline to 6 months Quick DASH
Change in Edema 6 weeks
Time frame: day 1, 6 weeks
Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx
Change in Edema 3 months
Time frame: day 1, 3 months
Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx
Change in Edema 6 months
Time frame: day 1, 6 months
Baseline to 6 months weeks Circumferential measurement in centimeters of the proximal phalanx
Change in Pain on a likert scale 6 weeks
Time frame: 1 day, 6 weeks
Baseline to 6 weeks pain on a 0-10 scale
Change in Pain on a likert scale 3 months
Time frame: 1 day, 3 months
Baseline to 3 months pain on a 0-10 scale
Change in Pain on a likert scale 6 months
Time frame: 1 day, 6 months
Baseline to 6 months pain on a 0-10 scale
Change in Range of motion 6 weeks
Time frame: 1 day, 6 weeks
Baseline to 6 weeks flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
Change in Range of motion 3 months
Time frame: 1 day, 3 months
Baseline to 3 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
Change in Range of motion 6 months
Time frame: 1 day, 6 months
Baseline to 6 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.
Change in Severity or Grade of triggering 6 weeks
Time frame: 1 day, 6 weeks
Baseline to 6 weeks Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
Change in Severity or Grade of triggering 3 months
Time frame: 1 day, 3 months
Baseline to 3 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
Change in Severity or Grade of triggering 6 months
Time frame: 1 day, 6 months
Baseline to 6 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Background: PubMed 20825126Lewis E, Fors L, Tharion WJ. Interrater and intrarater reliability of finger goniometric measurements. Am J Occup Ther. 2010 Jul-Aug;64(4):555-61. doi: 10.5014/ajot.2010.09028.
- Individual participant dataSharing planned: No. There are no plans for sharing the IPD
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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.
Erika S. Lewis, Ed.D principal investigator
Associate Professor, University of Massachusetts Lowell
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Finger and Trigger Digit, run by University of Massachusetts, Lowell.
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 1 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 20 Feb 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Functional use using Quick DASH 6 weeks (time frame: Day 1, 6 weeks). The study lists 15 primary outcomes in all. 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 NCT03847935, which also lists 1 linked publication.
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 20 Feb 2019.