High Volume Saline Injections for Achilles Tendinopathy

Not Applicable

Completed

• Conditions: Midportion Achilles Tendinopathy; Musculoskeletal Diseases; Achilles tendinitis

• Registration Number: ISRCTN87144429
• Lead Sponsor: eeds Community Healthcare Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-24
• Study Completion: 2014-03-12
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Age: 18+
2. More than 13 weeks of pain in the Achilles tendon area
3. Ongoing symptoms despite completing an eccentric loading exercise programme with a physiotherapist
4. Achilles tendon is tender to palpation
5. Tendon diameter greater than 0.7cm on ultrasound scan (indicating tendinopathy)
6. Evidence of neovascularisation on doppler ultrasound scan
7. Sufficient English literacy skills to complete consent and questionnaires

Exclusion Criteria

1. Ultrasound evidence of tendon tear, intrasubstance defect or a previous history of tendon tear
2. Another co existing significant foot or ankle pathology, i.e. symptomatic osteoarthritis
3. Taking anticoagulant medication, clopidogrel or dipyridamole
4. A medical condition that would make treatment unsafe i.e. peripheral neuropathy, peripheral vascular disease or active infection
5. Previous achilles tendon surgery
6. Unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain, measured using 100mm Visual Analogue Pain Score at 6 weeks post injection

Secondary Outcome Measures

Name	Time	Method
<br> 1. Foot and ankle function, measured using the Foot and Ankle Outcome Score (FAOS) at 6 weeks post injection<br> 2. Health status, measured using EQ5D-3L at 6 weeks post injection<br> 3. Diameter of symptomatic achilles tendon, measured by ultrasound scan at 6 weeks post injection<br> 4. Neovascularisation grading: a grading of the amount of new vessel growth into the tendon as seen on ultrasound scan at 6 weeks post injection<br> 5. The cohort of patients will have all outcome measures reviewed at 12 and 40 weeks to ensure resolution of symptoms and to look for evidence of symptom recurrence following injection<br>