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The TriggerHappy Trial (Triggerhappy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568993
Recruitment Status : Active, not recruiting
First Posted : September 29, 2020
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Joakim Stromberg, Sahlgrenska University Hospital, Sweden

Study Description
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Brief Summary:
This is a prospective randomized multicenterstudy focusing on PROMs after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.

Condition or disease Intervention/treatment Phase
Trigger Finger Trigger Thumb Minimally Invasive Surgery Procedure: Proximal phalangeal level Drug: Volar to the MCP-joint Not Applicable

Detailed Description:
This study aims to compare two different methods of corticosteroid injections in patients with triggerfinger, and to study the effects of these injections by day-to-day self-assessment by the included study persons for four weeks. The patient assess: 1. Pain 2. Motion and 3. Triggering by VAS scale every day for four weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient-reported Outcome After Corticoid Injection for Triggerfinger- a Randomized Controlled Study Between Two Injection Procedures and Between Corticoid Injection and Percutaneous Release
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: proximal phalangeal level
injection in the the tendon sheet over proximal phalanx of finger
 Procedure: Proximal phalangeal level
Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx
Active Comparator: volar MCP level
injection above the A1 pulley volar to the MCP joint
 Drug: Volar to the MCP-joint
Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint


Outcome Measures
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Primary Outcome Measures :
  1. Pain after injection [ Time Frame: Four weeks ]
    Visual analouge scale (VAS), range 0-10, where 0 indicates "no pain" and 10 "maximum pain"

  2. Impairment of finger motion [ Time Frame: Four weeks ]
    Visual analouge scale (VAS), range 0-10, where 0 indicates "no impairment" and 10 "maximum impairment"

  3. Triggering [ Time Frame: Four weeks ]
    Visual analouge scale (VAS), range 0-10, where 0 indicates "no trigger phenomenon" and 10 "Trigger phenomenon all the time/ locked finger"


Secondary Outcome Measures :
  1. Quick-DASH [ Time Frame: Four weeks ]
    generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:•

  1. Triggering of one or more fingers and/or impaired active finger motion and/or pain during active finger motion
  2. Localized tenderness volar to the MCP joint of the affected finger
  3. The patient seeks treatment

Exclusion Criteria:

  1. Previous treatment for triggerfinger in the finger to be treated
  2. Impaired function of finger due to previous trauma/infection or other condition
  3. Suspicion of other cause than triggeriinger/tendovaginitis
  4. Patient not able to follow instructions
Contacts and Locations
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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): NCT04568993


Locations
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Sweden
Alingsås Lasarett/ District Hospital
Alingsås, Sweden
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
More Information
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Responsible Party: Joakim Stromberg, Senior consultant surgeon, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04568993    
Other Study ID Numbers: The TriggerHappy Trial
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases