Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID03984955

A Prospective, Double Blind, Randomized Controlled Trial Comparing Physiotherapy Combined With Three Types of Image-Guided Injection for Tennis Elbow Pain and Function

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

123

Participants Needed

1

Research Sites

N/A

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, a common musculoskeletal condition causing pain at the lateral epicondyle of the humerus, is mainly due to overuse of wrist extensor muscles. Treatments vary from oral medications and physiotherapy to injections, with surgery reserved for resistant cases. This research aims to clarify the best approach by comparing physiotherapy combined with three types of injections for pain relief and function improvement in tennis elbow patients. Participants will all receive a structured, class-based physiotherapy program while being randomly assigned to one of three injection groups: a platelet-rich plasma (PRP) injection, a sodium hyaluronate with mannitol (Ostenil Tendon) injection, or a sham injection that penetrates the skin but delivers no therapeutic substance. Injections are administered under ultrasound guidance, and the study is designed as a double-blind, randomized controlled trial. Throughout the study, participants will complete questionnaires including pain scales and functional assessments at baseline, 3 months, and 12 months after treatment. They will keep a pain diary during the first 12 weeks and be monitored for medication use and recovery progress. The main outcome is the change in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score at 12 months, supplemented by other measures of pain, function, and quality of life, all conducted under blinded evaluation.

CONDITIONS

Brief Title

Comparing Injection Treatments for Tennis Elbow

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 18 years and above
  • Diagnosed with lateral epicondyle tendinosis (tennis elbow) with symptoms lasting more than 3 months
  • Symptoms and clinical evaluation warrant peri-tendinous injection for symptom relief
  • Competent to give informed consent
  • Referred to Orthopaedic Departments for tennis elbow treatment
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 anesthetic, PRP, or hyaluronic acid injections to the target elbow within the last 3 months
  • Known allergy to PRP, hyaluronic acid, or any injection components
  • Contraindications to normal treatment including local infection
  • Severe pathology in the same arm causing confusing pain
  • Pregnant or lactating 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 disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single injection followed by physiotherapy program lasting up to 12 weeks

Participants receive one of three types of ultrasound-guided injections for tennis elbow, followed by a class-based physiotherapy program starting 5 to 15 days after injection. Home exercises are taught on the day of treatment.

1 injection visit and fortnightly physiotherapy classes starting 5 to 15 days post-injection

Follow-up

Duration - Up to 12 months post-injection

Participants are assessed at 3 months and 12 months after injection. Outcome questionnaires are completed and use of pain medication is recorded. Follow-up may occur in person or by telephone.

2 visits (3 months and 12 months) with possible telephone follow-up

Trial Site Locations

Total: 1 location

1

Wrightington Wigan and Leigh NHS Foundation Trust

Wigan, Lancashire, United Kingdom, WN6 9EP

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Randomized Controlled Study of Blood Flow Restriction Traini...

Elbow Tendinopathy

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: a randomised controlled trial.

Nynke Smidt, Daniëlle A W M van der Windt, Willem J J Assendelft...

https://pubmed.ncbi.nlm.nih.gov/11879861

Therapeutic effects of hyaluronate injections in patients with chronic painful shoulder: a meta-analysis of randomized controlled trials.

Seiji Saito, Takefumi Furuya, Shigeru Kotake

https://pubmed.ncbi.nlm.nih.gov/20235211