Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger

Töölö Hospital

Status: Unknown

Conditions: Tendon Entrapment

Treatments: Other: Corticosteroid injection; Other: PRP injection; Other: Placebo injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04167098

2845/2019

Details and patient eligibility

About

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

Enrollment: 117 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

117 participants in 3 patient groups, including a placebo group

Platelet-Rich Plasma

Experimental group

Treatment:

Other: PRP injection

Corticosteroid

Active Comparator group

Treatment:

Other: Corticosteroid injection

0.9% saline

Placebo Comparator group

Treatment:

Other: Placebo injection