Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger
NCT ID: NCT04167098
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
117 participants
INTERVENTIONAL
2019-11-01
2022-07-01
Brief Summary
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Patients with clinically confirmed trigger finger are randomized (1:1:1 computer generated sequence with random block size) to three parallel groups and will receive an injection of either PRP, corticosteroid or placebo (0.9% saline) around the affected tendon sheath in a double-blind setting.
Baseline data is collected and is followed by a phone call at 1 month, and follow-up visits at 3, 6, 12 and 24 months after the intervention. Unveiling of the allocation is at 6 months post-intervention.
The primary outcome measures are:
* Symptom resolution
* Patient-Rated Wrist Evaluation
Secondary outcomes:
* Quick-Disabilities of the Arm, Shoulder and Hand
* Pain Visual Analogue Score
* Global improvement (7-step Likert-scale)
* Grip strength
* Finger range of motion
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Platelet-Rich Plasma
PRP injection
0.5 ml Platelet-rich Plasma around A1 tendon sheath
Corticosteroid
Corticosteroid injection
0.5 ml methylprednisolone around A1 tendon sheath
0.9% saline
Placebo injection
0.5 ml 0.9% saline around A1 tendon sheath
Interventions
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PRP injection
0.5 ml Platelet-rich Plasma around A1 tendon sheath
Corticosteroid injection
0.5 ml methylprednisolone around A1 tendon sheath
Placebo injection
0.5 ml 0.9% saline around A1 tendon sheath
Eligibility Criteria
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Inclusion Criteria
* Symptom duration \> 3 months
Exclusion Criteria
* Rheumatoid arthritis or other condition requiring continuous oral corticosteroids
* Previous history of surgery or injection to the affected ray
* Alcohol or drug abuse
* Mental instability
18 Years
75 Years
ALL
No
Sponsors
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Töölö Hospital
OTHER
Responsible Party
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Samuli Aspinen
Principal investigator
Locations
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Töölö Hospital (Helsinki University Hospital)
Helsinki, , Finland
Countries
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Central Contacts
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Facility Contacts
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Samuli Aspinen, M.D., Ph.D.
Role: primary
Jussi Kosola, M.D., Ph.D.
Role: backup
References
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Aspinen S, Nordback PH, Anttila T, Stjernberg-Salmela S, Ryhanen J, Kosola J. Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial. Trials. 2020 Nov 27;21(1):984. doi: 10.1186/s13063-020-04907-w.
Other Identifiers
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2845/2019
Identifier Type: -
Identifier Source: org_study_id