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Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger

NCT04167098 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2020-12-17

No results posted yet for this study

Summary

Study purpose is to evaluate the effectiveness of Platelet-rich Plasma (PRP) injection in the treatment of trigger finger. We compare PRP to a corticosteroid (methylprednisolone) injection in a prospective randomized triple-blind placebo-controlled study.

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

Conditions

  • Tendon Entrapment

Interventions

OTHER

PRP injection

0.5 ml Platelet-rich Plasma around A1 tendon sheath

OTHER

Corticosteroid injection

0.5 ml methylprednisolone around A1 tendon sheath

OTHER

Placebo injection

0.5 ml 0.9% saline around A1 tendon sheath

Sponsors & Collaborators

  • Töölö Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-07-01
Completion
2022-07-01

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167098 on ClinicalTrials.gov