Trigger Finger Treatment

Sponsor
University of Massachusetts, Lowell (Other)
Overall Status
Completed
CT.gov ID
NCT03847935
Collaborator
University of Massachusetts, Worcester (Other)
86
60

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Dec 10, 2007
Actual Primary Completion Date :
Dec 8, 2012
Actual Study Completion Date :
Dec 8, 2012

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. Change in Functional use using Quick DASH 6 weeks [Day 1, 6 weeks]

      Change from baseline to 6 weeks Quick DASH

    2. Change in Functional use using Quick DASH 3 months [Day 1, 3 months]

      Change from baseline to 3 months Quick DASH

    3. Change in Functional use using Quick DASH 6 months [Day 1, 6 months]

      Change from baseline to 6 months Quick DASH

    4. Change in Edema 6 weeks [day 1, 6 weeks]

      Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx

    5. Change in Edema 3 months [day 1, 3 months]

      Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx

    6. Change in Edema 6 months [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 [1 day, 6 weeks]

      Baseline to 6 weeks pain on a 0-10 scale

    8. Change in Pain on a likert scale 3 months [1 day, 3 months]

      Baseline to 3 months pain on a 0-10 scale

    9. Change in Pain on a likert scale 6 months [1 day, 6 months]

      Baseline to 6 months pain on a 0-10 scale

    10. Change in Range of motion 6 weeks [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 [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • trigger finger in digit 2-5
    Exclusion Criteria:
    • if prior treatment for trigger finger, or Trigger thumb

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Massachusetts, Lowell
    • University of Massachusetts, Worcester

    Investigators

    • Principal Investigator: Erika S. Lewis, Ed.D, Associate Professor, University of Massachusetts Lowell

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    ELewis, Associate Professor, University of Massachusetts, Lowell
    ClinicalTrials.gov Identifier:
    NCT03847935
    Other Study ID Numbers:
    • H-12583
    First Posted:
    Feb 20, 2019
    Last Update Posted:
    Feb 20, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ELewis, Associate Professor, University of Massachusetts, Lowell
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 20, 2019