Samsung Medical Center
Seoul, 135-710, South Korea
NCT Number: NCT01781130
Background
Present treatment strategies for trigger finger when conservative management including steroid injection was failed include percutaneous or open A1 pulley release, but some people showed prolonged swelling and delay of complete healing.
We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid injection simultaneously with percutaneous release compared with conventional percutaneous release alone
Methods
We designed a double-blind, randomized controlled trial.
Inclusion criteria is the patient who has symptom of trigger finger warranted surgical release after sufficient time of conservative treatment.
Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5) Previous surgery history of finger 6); the patients who got steroid injection more than 4 time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.
After power analysis by a statistician, total 40 patients would be required for each group (percutaneous alone group versus percutaneous alone + steroid injection group).
The surgery will be performed by outpatients clinic basis with local injection. Additional steroid injection will be given to half of patients after allocation with randomized selection by permutaed block randomization.
Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary outcome will be proportion of patients with good response (defined as "Perfect" or "much better" as reported by patients).
Follow-up will be conducted 3 weeks and 3 month after index procedure
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Seoul, 135-710, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 month after procedure
Samsung Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05032508
Muscular Diseases, Musculoskeletal Diseases
Paris, France
View Trial DetailsNCT07364695
Muscular Diseases, Musculoskeletal Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT07482397
Muscular Diseases, Musculoskeletal Diseases
Toba Tek Singh, Punjab Province, Pakistan
View Trial DetailsNCT05251428
Muscular Diseases, Musculoskeletal Diseases
Atlanta, Georgia, United States
View Trial Details