What is this study trying to find out about tennis elbow?

This study is evaluating how adding different types of injection therapies to physiotherapy affects pain and arm function for people with tennis elbow. It aims to find out which injection method, if any, improves symptoms best. The research is sponsored by Wrightington, Wigan and Leigh NHS Foundation Trust to help guide future treatment choices.

Who may be eligible for this tennis elbow clinical trial?

Adults aged 18 to 75 with a diagnosis of tennis elbow lasting more than 3 months may be eligible. Both men and women can join if they have tenderness at the elbow and require injection treatment. People who recently had similar injections or have certain medical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this tennis elbow clinical trial?

Study-related care, including the study injections and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 75Years

All Genders

ID03984955

Comparing Physiotherapy Plus One of Three Injection Treatments for Tennis Elbow Pain and Function

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

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Participants Needed

Research Sites

N/A

Total Duration

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

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

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

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