Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger
- Conditions
- Tendon Entrapment
- Interventions
- Other: PRP injectionOther: Placebo injectionOther: Corticosteroid injection
- Registration Number
- NCT04167098
- Lead Sponsor
- Töölö Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 117
- Age 18 - 75
- Symptom duration > 3 months
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Platelet-Rich Plasma PRP injection - 0.9% saline Placebo injection - Corticosteroid Corticosteroid injection -
- Primary Outcome Measures
Name Time Method Symptom resolution 24 months 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 24 months 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
Name Time Method Global improvement 24 months 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
Quick-Disabilities of the Arm, Shoulder and Hand 24 months 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)
Grip strength 24 months 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) 24 months The ROM of the finger is measured on both hands with a handheld goniometer in degrees.
Pain (Visual Analogue Scale) 24 months The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain).
Trial Locations
- Locations (1)
Töölö Hospital (Helsinki University Hospital)
🇫🇮Helsinki, Finland