Non insertional Achilles tendinopathy Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The study randomly assigns participants into two groups. One group receives the High Volume Ultrasound Guided Injection (HVUGI) whilst the other receives the current standard intervention of an eccent
Sponsors
University of Stirling
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Aged 18 or over 3. Capacity to give informed consent 4. Clinical diagnosis of unilateral non- insertional Achilles tendinopathy / plus diagnostic ultrasound confirmation. Clinical diagnosis would include the following: 4.1. Pain and tenderness on palpation of the Achilles tendon 2-6cm from the insertion in to the calcaneus. 4.2. Evidence of tendon thickening on palpation of the Achilles tendon. 4.3. Negative Simmonds-Thompson test. 4.4. Painful arc test 5. English is first language
Exclusion criteria
Exclusion criteria: 1. Concurrent musculoskeletal ankle problems. 2. Have a diagnosed rheumatological disorder. 3. Suffered partial /complete tear of the Achilles tendon 4. Previous injection for non- insertional Achilles tendinopathy 5. Previous surgery to the Achilles tendon. 6. Patients with bilateral non insertional Achilles tendinopathy. 7. Currently taking quinolone antibiotics 8. Previous allergy to local anaesthesia. 9. English is not the first language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this is a feasibility study the primary aims are to assess the proposed processes associated with carrying out a large scale RCT, and will review and evaluate three key elements, recruitment, follow up and safety: 1.1. Eligibility rate is assessed as the number of eligible subjects as a proportion of the total screened patients in a three month period. 1.2. Recruitment rate is assessed as the number of recruited patients as a proportion of the number of eligible patients within the three month period. 1.3. Test the proposed method of randomisation- even balance of subject numbers in each arm of the study. 1.4. To evaluate compliance with the intervention- the eccentric loading group are required to carry our relatively painful exercises for 12 weeks. Compliance is evaluated with the use of an adherence diary which will record frequency (number of sessions per week) and intensity (number of repetitions per session). 1.5. To explore patient’s experiences of the HVUGI regarding pain associated with the procedure and the immediate post- operative period 1.6. To evaluate follow up rates as measured as the total number of recruited subjects who are followed to the end of the study period 1.7. Evaluate the outcome measures utilised in the study- VISA-A questionnaire/Ohbergs modified neovascularity score 1.8. Record any adverse reactions to the HVUGI or the eccentric loading programme | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effect of high volume ultrasound guided injections compared with eccentric loading on pain and function in subjects with non-insertional Achilles tendinopathy is meaured using the VISA-A questionnaire 2. The effect of high volume ultrasound guided injection compared with eccentric loading on tendon thickness in subjects with non-insertional Achilles tendinopathy is measured using the Modified Ohberg neovascularisation Score 3. The effect of high volume ultrasound guided injections compared with eccentric loading on neovascularity in subjects with non-insertional Achilles tendinopathy is measurd using the ultrasound scanners digital measuring device | — |
Countries
United Kingdom
Outcome results
None listed