Randomised trial of treatment for tennis elbow comparing the effects of different injection treatments on pain reduction

Comparative effectiveness of ultrasound-guided injection with either autologous platelet rich plasma or glucocorticoid for ultrasound-proven lateral epicondylitis: a three-arm randomised placebo-controlled trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000616774

Enrollment

151

Registered

2013-05-29

Start date

2013-06-05

Completion date

2018-10-10

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Lateral epicondylitis (LE) or tennis elbow is a debilitating musculoskeletal condition that can result in significant disability, health care utilisation, lost productivity and costs. Glucocorticoid injection is of proven short-term benefit, but beyond 8 weeks its benefits have not been established and some studies have even suggested a rebound worsening of symptoms. Autologous platelet rich plasma (PRP) appears to be a promising new treatment for LE however strong evidence for its efficacy from high quality randomised placebo-controlled trials is currently lacking. The aim of this study is to compare the effectiveness of ultrasound-guided injection with either autologous platelet rich plasma or glucocorticoid using a three-arm randomised placebo-controlled trial design.

Interventions

1) single ultrasound guided injection of autologous platelet rich plasma (2ml) into the site of maximal abnormality in the elbow. To obtain the autologous platelet rich plasma, 5 ml of venesected blood will be centrifuged for 7 minutes at 1500 revs/sec and then the buffy coating and 2ml of the supernatant will be aspirated using a 22 gauge needle into a 3ml syringe. This 2ml will then be injected into the elbow. 2) single ultrasound guided injection of glucocorticoid (Celestone Chronodose 1ml

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1) lateral elbow pain > or = six weeks duration 2) reproducibility of pain by two or more of the following tests: palpation of the lateral epicondyle and/or the common extensor origin of the elbow, gripping, resisted wrist or second or third finger extension (dorsiflexion) 3) ultrasound-confirmed lesion 4) ability to read and write in English

Exclusion criteria

1) bilateral symptoms of lateral elbow pain 2) any other elbow pathology 3) generalised inflammatory arthritis such as rheumatoid arthritis 4) concurrent shoulder and/or neck pain and/or pain proximal to the elbow on the affected side 5) any wound or skin lesion on the lateral side of the affected elbow 6) neurological symptoms or signs in the affected arm 7) severe infection 8) known malignancy 9) bleeding disorder 10) previous surgery to the elbow 11) local glucocorticoid injection in the previous six months 12) oral glucocorticoids in the previous three months 13) large tear > or = 15mm in the common extensor origin or a torn lateral collateral ligament 14) lack of informed consent 15) any other reason thought likely to result in inability to complete the trial

Outcome results