Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger

NCT ID: NCT04167098

Last Updated: 2020-12-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-07-01

Brief Summary

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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

Detailed Description

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Conditions

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Tendon Entrapment

Keywords

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Platelet-Rich Plasma Trigger Finger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Platelet-Rich Plasma

Group Type EXPERIMENTAL

PRP injection

Intervention Type OTHER

0.5 ml Platelet-rich Plasma around A1 tendon sheath

Corticosteroid

Group Type ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type OTHER

0.5 ml methylprednisolone around A1 tendon sheath

0.9% saline

Group Type PLACEBO_COMPARATOR

Placebo injection

Intervention Type OTHER

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

Intervention Type OTHER

Corticosteroid injection

0.5 ml methylprednisolone around A1 tendon sheath

Intervention Type OTHER

Placebo injection

0.5 ml 0.9% saline around A1 tendon sheath

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Töölö Hospital

OTHER

Sponsor Role lead

Responsible Party

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Samuli Aspinen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Töölö Hospital (Helsinki University Hospital)

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Samuli Aspinen, M.D., Ph.D

Role: CONTACT

Phone: +358406360546

Email: [email protected]

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.

Reference Type DERIVED
PMID: 33246497 (View on PubMed)

Other Identifiers

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2845/2019

Identifier Type: -

Identifier Source: org_study_id