TY - JOUR
T1 - Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger
T2 - study protocol for a prospective randomized triple-blind placebo-controlled trial
AU - Aspinen, Samuli
AU - Nordback, Panu H.
AU - Anttila, Turkka
AU - Stjernberg-Salmela, Susanna
AU - Ryhänen, Jorma
AU - Kosola, Jussi
N1 - Funding Information:
The trial is funded by Helsinki University Hospital institutional funding and a grant received from the Finnish Society for Surgery of the Hand. No external funding from medical industry will be used. The funders will not have any role in the collection, management, analysis, and interpretation of data; the writing of the report; and the decision to submit the report for publication.
Publisher Copyright:
© 2020, The Author(s).
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020
Y1 - 2020
N2 - Background: Trigger finger is a common hand disorder that limits finger range of motion and causes pain and snapping of the affected finger. Trigger finger is caused by an imbalance of the tendon sheath and the flexor tendon. The initial treatment is generally a local corticosteroid injection around the first annular (A1) pulley. However, it is not unusual that surgical release of the A1 pulley is required. Moreover, adverse events after local corticosteroid injection or operative treatment may occur. Platelet-rich plasma (PRP) has been shown to be safe and to reduce symptoms in different tendon pathologies, such as DeQuervain’s disease. However, the effects of PRP on trigger finger have not been studied. The aim of this single-center triple-blind randomized controlled trial is to study whether PRP is non-inferior to corticosteroid injection in treating trigger finger. The secondary outcome is to assess the safety and efficacy of PRP in comparison to placebo. Methods: The trial is designed as a randomized, controlled, patient-, investigator-, and outcome assessor-blinded, single-center, three-armed 1:1:1 non-inferiority trial. The patients with clinical symptoms of trigger finger will be randomly assigned to treatment with PRP, corticosteroid, or normal saline injection. The primary outcome is Patient-Rated Wrist Evaluation and symptom resolution. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications. Appropriate statistical methods will be applied. Discussion: We present a novel RCT study design on the use of PRP for the treatment of trigger finger compared to corticosteroid and normal saline injection. The results of the trial will indicate if PRP is appropriate for the treatment of trigger finger. Trial registration: ClinicalTrials.gov NCT04167098. Registered on November 18, 2019.
AB - Background: Trigger finger is a common hand disorder that limits finger range of motion and causes pain and snapping of the affected finger. Trigger finger is caused by an imbalance of the tendon sheath and the flexor tendon. The initial treatment is generally a local corticosteroid injection around the first annular (A1) pulley. However, it is not unusual that surgical release of the A1 pulley is required. Moreover, adverse events after local corticosteroid injection or operative treatment may occur. Platelet-rich plasma (PRP) has been shown to be safe and to reduce symptoms in different tendon pathologies, such as DeQuervain’s disease. However, the effects of PRP on trigger finger have not been studied. The aim of this single-center triple-blind randomized controlled trial is to study whether PRP is non-inferior to corticosteroid injection in treating trigger finger. The secondary outcome is to assess the safety and efficacy of PRP in comparison to placebo. Methods: The trial is designed as a randomized, controlled, patient-, investigator-, and outcome assessor-blinded, single-center, three-armed 1:1:1 non-inferiority trial. The patients with clinical symptoms of trigger finger will be randomly assigned to treatment with PRP, corticosteroid, or normal saline injection. The primary outcome is Patient-Rated Wrist Evaluation and symptom resolution. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications. Appropriate statistical methods will be applied. Discussion: We present a novel RCT study design on the use of PRP for the treatment of trigger finger compared to corticosteroid and normal saline injection. The results of the trial will indicate if PRP is appropriate for the treatment of trigger finger. Trial registration: ClinicalTrials.gov NCT04167098. Registered on November 18, 2019.
KW - Clinical trial
KW - Platelet-rich plasma
KW - Stenosing tenosynovitis
KW - Trigger finger
KW - Trigger thumb
U2 - 10.1186/s13063-020-04907-w
DO - 10.1186/s13063-020-04907-w
M3 - Article
C2 - 33246497
AN - SCOPUS:85096718284
SN - 1745-6215
VL - 21
JO - Trials
JF - Trials
IS - 1
M1 - 984
ER -