Treatment of Epicondylitis by Ultrasound-guided Local Injections of Autologous Conditioned Plasma (ACP®): a Double-blind Placebo-controlled Randomized Clinical Trial With One-year Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Global pain score
Study Overview
Brief Summary
The purpose of this study is to assess efficacy of two intra-tendinous injections of platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤ 3 months) compared compared to two intra-tendinous injections of saline solution (placebo).
Detailed Description
This was a prospective double-blind placebo-controlled randomized trial. Two ultrasound-guided injections of either PRP (ACP®, Arthrex) or saline solution were performed at 4 weeks interval.
Exclusion criterion was previous corticosteroid infiltration. All infiltrations were performed by Dr Bernard Montalvan. The selection of patients and the evaluation were conducted by Dr Patrick Le Goux who did not know which treatment had been allocated to which patient.
In the facility, no one apart from the investigators had access to full patient data.
An independent company represented by Mrs Amandine Ramseyer was hired to design, follow and carry the statistical analysis of the study. The data she got from the investigators were anonymous.
Patients were monitored by an independent evaluator blinded to treatment at baseline and 1, 3, 6 and 12 months follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients suffering from tennis elbow for less than three months
- •Patients having never received former medical or orthopedic treatment for tennis elbow
Exclusion Criteria
- •Patients having received any treatment for this specific pathology
- •Evidence of ongoing tumoral affection (controlled by MRI)
- •Tennis elbow history
- •Elbow fracture history
- •Associated elbow pathology
- •Inflammatory rheumatic disorders
- •Bleeding disorders
- •Ongoing anticoagulation therapy
- •Allergy to local anesthetic
- •Ongoing or previous cancer affection
- •Pregnancy
Outcomes
Primary Outcomes
Global pain score
Time Frame: 1 year
Secondary Outcomes
- Roles and Maudsley score(1 year)
- Pain on ECRB* contraction(1 year)
- Pain on EDC** contraction(1 year)