Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- McMaster University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Pain Reduction
Study Overview
Brief Summary
"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.
Many treatments have been attempted, including physiotherapy and steroids, with little success. One treatment which has been very effective is the injection of the patients own blood (taken from their other non-affected arm) into their abnormal tendon. The blood recruits the patients own healing factors and heals the damaged tendon. As platelets are thought to be largely responsible, injection of concentrated platelets, extracted from the patient's blood (platelet rich plasma) is a newer, but expensive, technique.
At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing (tendon fenestration) is the better treatment.
The objective of this trial is to compare platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy) to identify the best and most cost-effective therapy for this debilitating condition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult man or woman aged 18 years or greater.
- •Clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with active extension of the wrist in pronation and elbow extension.
- •Documented sonographic diagnosis of common extensor tendinosis based on tendon thickening, areas of hypoechogenicity, and loss of the normal echotexture.
- •Chronic symptoms (equal or greater than 3 months).
- •Pain of at least 5 out of 10 on a visual analog scale (VAS).
- •Provision of informed consent.
Exclusion Criteria
- •Acute symptom onset (less than 2 months).
- •History of acute elbow trauma (less than one week).
- •History of rheumatoid arthritis.
- •History of malignancy.
- •Pregnancy
- •Patients requiring anti-platelet medication for the treatment of heart attack, stroke or other medical condition.
- •Previous surgery for lateral epicondylitis.
- •Previous local injections, including steroids within the past 6 months.
- •Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, osteochondral lesion).
Arms & Interventions
Platelet Rich Plasma (PRP) Injection
Patients in this arm will receive a platelet rich plasma injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
Intervention: Platelet Rich Plasma (PRP) Injection (Other)
Whole Blood Injection
Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
Intervention: Whole Blood Injection (Other)
Dry Needle Fenestration
Patients in this arm will receive 15-25 gentle strokes of dry needling (piercing of the tendon) at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
Intervention: Dry Needle Fenestration (Other)
Sham Injection
Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
Intervention: Sham Injection (Other)
Outcomes
Primary Outcomes
Pain Reduction
Time Frame: Baseline, 6 weeks, 3, 6, 12 months
Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain).
Secondary Outcomes
- Psychological Impairment(Baseline, 6 weeks, 3, 6, 12, 24 months)
- Functional Disability(Baseline, 6 weeks, 3, 6, 12, 24 months)
- Health-Related Quality of Life(Baseline, 6 weeks, 3, 6, 12, 24 months)