NCT04167098

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

November 10, 2019

Last Update Submit

December 15, 2020

Conditions

Tendon Entrapment

Keywords

Platelet-Rich PlasmaTrigger Finger

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Quick-Disabilities of the Arm, Shoulder and Hand

    24 months

  • Pain (Visual Analogue Scale)

    24 months

  • Global improvement

    24 months

  • Grip strength

    24 months

  • Finger range of motion (ROM)

    24 months

Study Arms (3)

Platelet-Rich Plasma

EXPERIMENTAL
Other: PRP injection

Corticosteroid

ACTIVE COMPARATOR
Other: Corticosteroid injection

0.9% saline

PLACEBO COMPARATOR
Other: Placebo injection

Interventions

PRP injectionOTHER

0.5 ml Platelet-rich Plasma around A1 tendon sheath

Platelet-Rich Plasma
Corticosteroid injectionOTHER

0.5 ml methylprednisolone around A1 tendon sheath

Corticosteroid
Placebo injectionOTHER

0.5 ml 0.9% saline around A1 tendon sheath

0.9% saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 75
  • Symptom duration \> 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Töölö Hospital (Helsinki University Hospital)

Helsinki, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33246497DERIVED

MeSH Terms

Conditions

Tendon EntrapmentTrigger Finger Disorder

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Samuli Aspinen, M.D., Ph.D

CONTACT

+358406360546samuli.aspinen@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 18, 2019

Study Start

November 1, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)