A Prospective Randomized Placebo-controlled Trial Comparing Platelet-rich Plasma and Corticosteroid Injection for Treatment of Trigger Finger
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tendon Entrapment
- Sponsor
- Töölö Hospital
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Symptom resolution
- Last Updated
- 5 years ago
Overview
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
Investigators
Samuli Aspinen
Principal investigator
Töölö Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 18 - 75
- •Symptom duration \> 3 months
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Symptom resolution
Time Frame: 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
Time Frame: 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 Outcomes
- Global improvement(24 months)
- Quick-Disabilities of the Arm, Shoulder and Hand(24 months)
- Grip strength(24 months)
- Finger range of motion (ROM)(24 months)
- Pain (Visual Analogue Scale)(24 months)