Topic: Musculoskeletal disorders
Conditions
Interventions
Injection of either whole blood, platelet-rich plasma or saline using a technique called needle barbotage that disrupts tendon fibres and promotes the healing process
Follow Up Length: 12 month(s)
Sponsors
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Established lateral epicondyle tendinopathy with a minimum symptom duration of 3 months 2. Aged 18 years or above and below 65 years 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient rated tennis elbow evaluation (PRTEE); Timepoint(s): 12 weeks post-injection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events; Timepoint(s): peri-procedural, 6 weeks, 12 weeks, 6 months and 12 months 2. Disabilities of the arm, shoulder and hand (DASH) questionnaire; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months 3. EQ-5D; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months 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 6. Mayo elbow performance indicator (MEPI); Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months; Recruitment rate; Timepoint(s): 12 months 7. Visual analogue pain score; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactJohanna Wales
Outcome results
None listed