Tendon Entrapment Clinical Trial
Official title:
A Prospective Randomized Placebo-controlled Trial Comparing Platelet-rich Plasma and Corticosteroid Injection for Treatment of Trigger Finger
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
| Status | Recruiting |
| Enrollment | 117 |
| Est. completion date | July 1, 2022 |
| Est. primary completion date | July 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Töölö Hospital (Helsinki University Hospital) | Helsinki |
| Lead Sponsor | Collaborator |
|---|---|
| Töölö Hospital |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Finger range of motion (ROM) | The ROM of the finger is measured on both hands with a handheld goniometer in degrees. | 24 months |