Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
This study is currently recruiting participants.
Verified February 2012 by Regionshospitalet Silkeborg
Sponsor:
Jeppe Lange, MD
Information provided by (Responsible Party):
Jeppe Lange, MD, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT01486420
First received: December 1, 2011
Last updated: February 14, 2012
Last verified: February 2012
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Purpose
The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.
| Condition | Intervention |
|---|---|
|
Trigger Finger |
Procedure: Corticosteroid injections Procedure: Open surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial. |
Resource links provided by NLM:
Further study details as provided by Regionshospitalet Silkeborg:
Primary Outcome Measures:
- Quinell grade [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb.
Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.
Secondary Outcome Measures:
- Numerical Rating Scale (NRS) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)
- infection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Infection occurence following either procedure
| Estimated Enrollment: | 166 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Open surgery |
Procedure: Open surgery
Open A1-pulley release
|
| Active Comparator: Corticosteroid Injection |
Procedure: Corticosteroid injections
Corticosteroid injections in and around A1-pulley.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Trigger finger Quinell grade IIb-V in digit I-V
Exclusion Criteria:
- Former treatment of Trigger finger in affected digit
- Dupuytrens contracture in affected digit
- Allergies or intolerance to used medications
- Rheumatoid Arthritis
- Insulin dependent Diabetes Mellitus
- Amyloidosis
- Mucopolysaccharidosis
- Already included in study with another digit
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486420
Contacts
| Contact: Rehne L. Hansen, M.D. | +45 87 22 21 00 | rehnhans@rm.dk |
| Contact: Jeppe Lange, M.D. | jeppe.lange@ki.au.dk |
Locations
| Denmark | |
| Center for Planned surgery - Regionalhospital Silkeborg | Recruiting |
| Silkeborg, Denmark, 8600 | |
| Contact: Soren Mikkelsen, M.D +45 87 22 24 64 | |
| Principal Investigator: Rehne L. Hansen, M.D. | |
Sponsors and Collaborators
Jeppe Lange, MD
Investigators
| Study Director: | Jeppe Lange, M.D. | Center for Planned Surgery - Regionalhospital Silkeborg |
More Information
No publications provided
| Responsible Party: | Jeppe Lange, MD, Senior project superviser, Regionshospitalet Silkeborg |
| ClinicalTrials.gov Identifier: | NCT01486420 History of Changes |
| Other Study ID Numbers: | M-20110157 |
| Study First Received: | December 1, 2011 |
| Last Updated: | February 14, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by Regionshospitalet Silkeborg:
|
Quinell grade Open surgery corticosteroid injections randomized controlled trial Trigger finger |
Additional relevant MeSH terms:
|
Trigger Finger Disorder Tendon Entrapment Tenosynovitis |
Tendinopathy Muscular Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013