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Trigger Finger Treatment

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ClinicalTrials.gov Identifier: NCT03847935
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
ELewis, University of Massachusetts, Lowell

Brief 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 hand therapy.

Condition or disease Intervention/treatment
Trigger Finger Trigger Digit Stenosing Tenosynovitis Procedure: surgery Procedure: corticosteroid injections Other: Hand Therapy Other: Modality 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.

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trigger Finger Treatment - An Outcomes Study. Comparing 6 Traditional Treatment Techniques
Actual Study Start Date : December 10, 2007
Actual Primary Completion Date : December 8, 2012
Actual Study Completion Date : December 8, 2012

Group/Cohort Intervention/treatment
Surgery
Patients who underwent surgical release of A1 pulley
Procedure: surgery
A1 pulley release of finger

corticosteroid injections only
Patients who underwent local corticosteroid injections only, and no other treatment
Procedure: corticosteroid injections
corticosteroid injection to A1 pulley

hand therapy only occupational/physical
1 visit: orthosis fabrication, range of motion, nodule and ice massage.
Other: Hand Therapy
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,
Other Names:
  • physical therapy
  • occupational 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.
Procedure: corticosteroid injections
corticosteroid injection to A1 pulley

Other: Hand Therapy
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,
Other Names:
  • physical therapy
  • occupational therapy

Modality Hand Therapy
Ongoing hand therapy treatment, which included the above plus modalities such as ultrasound or iontophoresis.
Other: Modality Hand Therapy
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis

Injection and Modality Hand Therapy
Ccombination of local cortiscosteroid injection to the affected digit and ongoing hand therapy with modalities.
Procedure: corticosteroid injections
corticosteroid injection to A1 pulley

Other: Modality Hand Therapy
orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis




Primary Outcome Measures :
  1. Change in Functional use using Quick DASH 6 weeks [ Time Frame: Day 1, 6 weeks ]
    Change from baseline to 6 weeks Quick DASH

  2. Change in Functional use using Quick DASH 3 months [ Time Frame: Day 1, 3 months ]
    Change from baseline to 3 months Quick DASH

  3. Change in Functional use using Quick DASH 6 months [ Time Frame: Day 1, 6 months ]
    Change from baseline to 6 months Quick DASH

  4. Change in Edema 6 weeks [ Time Frame: day 1, 6 weeks ]
    Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx

  5. Change in Edema 3 months [ Time Frame: day 1, 3 months ]
    Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx

  6. Change in Edema 6 months [ Time Frame: day 1, 6 months ]
    Baseline to 6 months weeks Circumferential measurement in centimeters of the proximal phalanx

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • trigger finger in digit 2-5

Exclusion Criteria:

  • if prior treatment for trigger finger, or Trigger thumb

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847935


Sponsors and Collaborators
University of Massachusetts, Lowell
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Erika S. Lewis, Ed.D Associate Professor, University of Massachusetts Lowell

Publications:
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Responsible Party: ELewis, Associate Professor, University of Massachusetts, Lowell
ClinicalTrials.gov Identifier: NCT03847935     History of Changes
Other Study ID Numbers: H-12583
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans for sharing the IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ELewis, University of Massachusetts, Lowell:
treatment outcome
hand therapy
physical therapy
occupational therapy
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tenosynovitis
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases