Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger

Study Overview
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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

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

Conditions
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Tendon Entrapment

Intervention / Treatment
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* Other: PRP injection
* Other: Corticosteroid injection
* Other: Placebo injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-Rich Plasma, Trigger Finger