Clinical trial NCT01851044: The Effect of Platelet Rich Plasma on Lateral Epicondylitis
Official title: The Treatment of Lateral Epicondylitis: the Effect of Platelet Rich Plasma on Healing -- A Randomized Controlled Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Elbow Pain
Keywords: Platelet Rich Plasma
Whole Blood Injection
Lateral Epicondylitis
Tennis Elbow
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Hatanpää City Hospital, Tampere, Finland
First posted: 2013-05-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of platelet rich plasma, whole blood and saline vehicle on the natural course of lateral epicondylitis.

Detailed description: Lateral epicondylitis, also known as "tennis elbow", is the most common work-related disease of the upper extremity. Usually it has favorable natural healing-tendency, but sometimes it is responsible for long-lasting disability. The pathogenesis of this disease has remained unclear, however it has been speculated that the role of inflammation is smaller than previously believed. Instead, anatomical and vascular factors may play a much greater role. The evidence for the operative treatment is lacking, and the conservative treatment is therefore preferred. The conservative treatment used to rely largely on corticosteroid injections to the extensor muscle insertions. However, it has been shown that corticosteroids, in fact, tend to increase the subjective pain in the long run. Several studies -- most of them unfortunately underpowered -- have been carried out to find an efficient conservative treatment to this disease, but none of them has turned out to be significantly better than others. During the last couple of years, platelet rich plasma (PRP) has been used as a treatment in several musculoskeletal diseases (e.g. fracture healing, cartilage regeneration, wound healing). PRP is a substance centrifuged from patient own blood. There are a couple of studies regarding the use of PRP in lateral epicondylitis. The results are mostly positive; however it has not been thoroughly shown that it would be more effective than patient's whole blood. The hypothesis of this study is that PRP is more effective in the treatment of lateral epicondylitis than whole blood or saline vehicle injection. The primary outcome measures are pain (VAS) and the Disabilities of the Arm, Shoulder and Hand -score (DASH).

Eligibility criteria: Inclusion Criteria:

* The duration of symptoms over 3 months
* Primary conservative treatment (physiotherapy, NSAID, ...) has been tried

Exclusion Criteria:

* Significant systemic diseases
* Any surgical operation of the particular elbow

Primary outcomes:
measure: Pain (Visual Analog Scale)
timeFrame: 52 weeks
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand -score
timeFrame: 52 weeks
Other outcomes:
measure: Grip strength (Jamar)
timeFrame: 52 weeks
measure: Need for non-steroidal anti-inflammatory drugs (NSAID)
timeFrame: 52 weeks
measure: The duration of the potential sick leave due to lateral epicondylitis
timeFrame: 52 weeks
Locations:
city: Tampere
country: Finland
facility: Hatanpää City Hospital
Study officials:
References:
citation: Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.