Table 2 Content of the trial registry
Data category | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov; NCT04167098 |
Date of registration in primary registry | November 18, 2019 |
Date and version identifier | October 9, 2020, version 1.2 |
Source(s) of monetary or material support | – |
Primary sponsor | Töölö Hospital |
Secondary sponsor | University of Helsinki |
Contact for public queries | Samuli Aspinen, +358406360546, samuli.aspinen@hus.fi |
Contact for scientific queries | Samuli Aspinen, +358406360546, samuli.aspinen@hus.fi |
Public title | Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger |
Scientific title | A Prospective Randomized Placebo-controlled Trial Comparing Platelet-rich Plasma and Corticosteroid Injection for Treatment of Trigger Finger |
Countries of recruitment | Finland |
Health condition(s) or problem(s) | Tendon entrapment |
Intervention(s) | (1) PRP injection, 0.5 ml platelet-rich plasma around A1 tendon sheath; (2) corticosteroid injection, 0.5 ml methylprednisolone around A1 tendon sheath; and (3) placebo injection, 0.5 ml 0.9% saline around A1 tendon sheath |
Key inclusion and exclusion criteria | Inclusion: age 18–75, trigger finger in 1–2 rays, symptom duration > 3 months Exclusion: diabetes, rheumatoid arthritis or other condition requiring continuous oral corticosteroids, > 2 affected rays, previous history of surgery or injection to the affected ray, alcohol or drug abuse, mental instability |
Study type | Interventional |
Date of first enrolment | April 9, 2020 |
Target sample size | 117 |
Recruitment status | Recruiting |
Primary outcome(s) | Symptom resolution (rate of success), Patient-Rated Wrist Evaluation |
Key secondary outcomes | Quick-Disabilities of the Arm, Shoulder and Hand; pain (Visual Analogue Scale); global improvement; grip strength; finger range of motion (ROM); complications |