Comparing Injection Treatments for Tennis Elbow

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Tennis Elbow, Lateral Epicondylitis, Elbows Tendonitis

In brief

Tennis elbow is one of the most common musculoskeletal problems affecting the arm and is thought to be mainly due to overuse of the muscles that extend the wrist. The pain arises from the lateral epicondyle of the humerus, where the tendons of the wrist extensor muscles attach. There are many treatment options available for tennis elbow including oral medication, physiotherapy and injection therapy. Surgical options are reserved for those who fail to respond to more conservative treatments. Physiotherapy is a widely used, non-invasive treatment option for the management of tennis elbow. Research has shown that in the longer term, physiotherapy is superior to corticosteroid injection in the treatment of tennis elbow and a meta-analysis of published research concluded that Platelet Rich Plasma injection and Hyaluronic Acid injection are superior to corticosteroid for long term pain relief in tennis elbow. At present there is not enough evidence to indicate what the 'Gold Standard' treatment for tennis elbow is, and more research is therefore needed to help guide decision-making. The aim of this study is therefore to examine the effects of injection therapy in addition to physiotherapy treatment, in comparison to physiotherapy and a control injection on pain and function in patients with tennis elbow. All participants in this study will undergo a structured, specifically designed, class-based physiotherapy intervention, in addition to being randomly allocated to receive one of the following three types of injection: (a) a control injection whereby a needle is inserted into the skin but no therapeutic substance is injection, (b) a single therapeutic injection of platelet-rich plasm or (c) a single therapeutic injection of hyaluronic acid. Baseline data will be collected at the time of recruitment and participants will be followed up at 3 months and 12 months post treatment. Outcomes will be assessed using various patient-reported outcome measures in addition to clinical examination. The primary outcome for this study is the improvement in the quick DASH score at 12 months post-treatment compared to baseline.

Key facts

Study ID

NCT03984955

Run by

Wrightington, Wigan and Leigh NHS Foundation Trust

People needed

123

Starts

2018-04-18

Expected to finish

2026-02-06

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Invitations to participate in the study will be extended to male and female patients, 18 years and above, referred to the Orthopaedic Departments who receive a diagnosis of Lateral Epicondyle Tendinosis (with or without degenerative changes) with symptoms present for > 3 months, whose symptoms and clinical evaluation warrant the prescription of a peri-tendinous injection to relieve symptoms and who are competent to give informed consent.

You may not qualify if…

• Absence of tenderness at the lateral epicondyle.
• Congenital or traumatic bio-mechanical deformities of Elbow complex.
• Previous Corticosteroidal, Local Anaesthetic, PRP or Hyaluronic Acid injections to target elbow within the last three months.
• Known hypersensitivity to PRP, Hyaluronic acid or any excipients associated with any of the prescribed injections.
• Known contraindication to any treatments constituting normal/appropriate therapy in the view of the Consulting clinician including local infection
• Ipsilateral arm pathology severe enough to cause confusion of localised pain perception.
• Pregnant or lactating women
• Pain score less than 4/10
• Patients commenced on medication for the treatment of anxiety or depression within the last 6 weeks
• Previous involved in research in last 12 months
• Any progressive, degenerative neuromuscular disorder

Where it is running

• Wrightington Wigan and Leigh NHS Foundation Trust — Wigan, Lancashire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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