Tennis elbow platelet-rich plasma injection study

Completed

• Conditions: Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal; Musculoskeletal Diseases; Lateral epicondylitis

• Registration Number: ISRCTN12951626
• Lead Sponsor: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-16
• Study Completion: 2016-04-01
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Established lateral epicondyle tendinopathy with a minimum symptom duration of 3 months
2. Aged 18 or above and below 65
3. Willing to avoid the use of topical and oral nonsteroidal anti-inflammatory drugs for a period of 6 weeks following injection
4. Has completed the study physiotherapy program for a minimum period of 6 weeks with no improvement in symptoms
Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 18 years

Exclusion Criteria

1. Bilateral tennis elbow
2. Currently taking part in any interventional study that may impact upon study outcomes.
3. A concomitant injury that may impact on the ability to complete outcome assessments
4. Previous surgical intervention of the tendinopathy
5. Inflammatory disease, or chronic widespread pain syndrome
6. Requires regular use of anti-inflammatory medication for complaints other than Tennis Elbow
7. Known platelet dysfunction or thrombocytopaenia, or haemodynamic instability
8. Malignancy
9. Unable or unwilling to complete the 12 month follow-up assessments
10. Unable to communicate fluently in English or an inability to respond to validated questionnaires written in the English language
11. Platelet count <105/microlitre
12. Corticosteroid injection at the treatment site within the last 4 weeks, or systemic use of corticosteroids within the last 2 weeks. Anti-coagulation therapy within 5 days before treatment
13. Treatment with Non-steroidal anti-inflammatory drugs within 1 week prior to treatment
14. Septicaemia or fever

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient rated tennis elbow evaluation (PRTEE); Timepoint(s): 12 weeks post-injection

Secondary Outcome Measures

Name	Time	Method
1. Adverse events; Timepoint(s): peri-procedural, 6 weeks, 12 weeks, 6 months and 12 months<br>2. Disabilities of the arm, shoulder and hand (DASH) questionnaire; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months<br>3. EQ-5D; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months<br>4. Health economic data (resourse usage); Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months; 5. Loss to follow-up and withdrawal rates; Timepoint(s): 12 months<br>6. Mayo elbow performance indicator (MEPI); Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months; Recruitment rate; Timepoint(s): 12 months<br>7. Visual analogue pain score; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months