Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT03984955

Comparing Injection Treatments for Tennis Elbow

Led by Wrightington, Wigan and Leigh NHS Foundation Trust · Updated on 2024-08-06

123

Participants Needed

1

Research Sites

407 weeks

Total Duration

On this page

Sponsors

W

Wrightington, Wigan and Leigh NHS Foundation Trust

Lead Sponsor

T

TRB Chemedica

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparing Injection Treatments for Tennis Elbow

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 years or older
  • Diagnosed with lateral epicondyle tendinosis (tennis elbow) with or without degenerative changes
  • Symptoms present for more than 3 months
  • Symptoms and clinical evaluation warrant peri-tendinous injection for symptom relief
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • No tenderness at the lateral epicondyle
  • Congenital or traumatic biomechanical deformities of the elbow
  • Received corticosteroid, local anaesthetic, PRP, or hyaluronic acid injections in the target elbow within the last 3 months
  • Known allergy to PRP, hyaluronic acid, or any injection ingredients
  • Contraindications to normal treatments including local infection
  • Severe ipsilateral arm problems causing unclear pain
  • Pregnant or breastfeeding women
  • Pain score less than 4 out of 10
  • Started medication for anxiety or depression within the last 6 weeks
  • Participated in research in the last 12 months
  • Progressive degenerative neuromuscular disorder

AI-Screening

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Trial Site Locations

Total: 1 location

1

Wrightington Wigan and Leigh NHS Foundation Trust

Wigan, Lancashire, United Kingdom, WN6 9EP

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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