Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger

A Prospective Randomized Placebo-controlled Trial Comparing Platelet-rich Plasma and Corticosteroid Injection for Treatment of Trigger Finger

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

Study Overview

• Status: Unknown
• Conditions: Tendon Entrapment
• Intervention / Treatment: Other: PRP injection; Other: Corticosteroid injection; Other: Placebo injection

• Study Type: Interventional
• Enrollment (Anticipated): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Töölö Hospital (Helsinki University Hospital)
    • Contact: Jussi Kosola, M.D., Ph.D.; Email: jussi.kosola@helsinki.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 - 75
• Symptom duration > 3 months

Exclusion Criteria:

• Diabetes
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-Rich Plasma	Other: PRP injection; 0.5 ml Platelet-rich Plasma around A1 tendon sheath
Active Comparator: Corticosteroid	Other: Corticosteroid injection; 0.5 ml methylprednisolone around A1 tendon sheath
Placebo Comparator: 0.9% saline	Other: Placebo injection; 0.5 ml 0.9% saline around A1 tendon sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom resolution	4-step Likert (0 = no response; 1 = partial response, but not satisfactory, warranting further treatment; 2 = partial response, satisfactory, not warranting further treatment; 3 = complete resolution of symptoms and signs)	24 months
Patient-Rated Wrist Evaluation	The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick-Disabilities of the Arm, Shoulder and Hand	he QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)	24 months
Pain (Visual Analogue Scale)	The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain).	24 months
Global improvement	Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better	24 months
Grip strength	Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side.	24 months
Finger range of motion (ROM)	The ROM of the finger is measured on both hands with a handheld goniometer in degrees.	24 months

Collaborators and Investigators

• Sponsor: Töölö Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Trigger Finger; Platelet-Rich Plasma
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Trigger Finger Disorder; Tendon Entrapment
• Other Study ID Numbers: 2845/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No