Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger
Primary Purpose
Tendon Entrapment
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
PRP injection
Corticosteroid injection
Placebo injection
Sponsored by
About this trial
This is an interventional treatment trial for Tendon Entrapment focused on measuring Platelet-Rich Plasma, Trigger Finger
Eligibility Criteria
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
Sites / Locations
- Töölö Hospital (Helsinki University Hospital)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Platelet-Rich Plasma
Corticosteroid
0.9% saline
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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)
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).
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
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.
Finger range of motion (ROM)
The ROM of the finger is measured on both hands with a handheld goniometer in degrees.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04167098
Brief Title
Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger
Official Title
A Prospective Randomized Placebo-controlled Trial Comparing Platelet-rich Plasma and Corticosteroid Injection for Treatment of Trigger Finger
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Töölö Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Entrapment
Keywords
Platelet-Rich Plasma, Trigger Finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet-Rich Plasma
Arm Type
Experimental
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Title
0.9% saline
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
PRP injection
Intervention Description
0.5 ml Platelet-rich Plasma around A1 tendon sheath
Intervention Type
Other
Intervention Name(s)
Corticosteroid injection
Intervention Description
0.5 ml methylprednisolone around A1 tendon sheath
Intervention Type
Other
Intervention Name(s)
Placebo injection
Intervention Description
0.5 ml 0.9% saline around A1 tendon sheath
Primary Outcome Measure Information:
Title
Symptom resolution
Description
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)
Time Frame
24 months
Title
Patient-Rated Wrist Evaluation
Description
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)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quick-Disabilities of the Arm, Shoulder and Hand
Description
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)
Time Frame
24 months
Title
Pain (Visual Analogue Scale)
Description
The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain).
Time Frame
24 months
Title
Global improvement
Description
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
Time Frame
24 months
Title
Grip strength
Description
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.
Time Frame
24 months
Title
Finger range of motion (ROM)
Description
The ROM of the finger is measured on both hands with a handheld goniometer in degrees.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuli Aspinen, M.D., Ph.D
Phone
+358406360546
Email
samuli.aspinen@hus.fi
Facility Information:
Facility Name
Töölö Hospital (Helsinki University Hospital)
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuli Aspinen, M.D., Ph.D.
Phone
+358406360546
Email
samuli.aspinen@hus.fi
First Name & Middle Initial & Last Name & Degree
Jussi Kosola, M.D., Ph.D.
Email
jussi.kosola@helsinki.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33246497
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger
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