ERASE The Efficacy of RadiAl ShockwavE therapy compared with sham shockwave therapy in insertional Achilles tendinopathy. A randomised controlled trial
ACTRN12620000035921
Treatment
Not Applicable
Commercial sector/Industry,DJO Global
A/Prof Peter Malliaras
Achilles tendinopathy is a common, painful and disabling musculoskeletal condition. There is a treatment called radial shockwave therapy (rSWT) that produces a pressure wave that enters the Achilles tendon. Some studies report positive findings for this treatment in insertional Achilles tendinopathy but it is not certain whether rSWT is better than placebo. The proposed study is a two-arm, parallel group, double-blind randomised prospective trial. Participants will be block-randomised into sham .... Read more
Aged 18 years or older >3 months of pain at the insertion of the Achilles to the posterior calcaneal surface Primary complaint of insertional Achilles pain on one or both lower limbs Clinical diagnosis of insertional Achilles tendinopathy based on the following criteria: o Gradual onset pain in the relevant area; o Pain during or after Achilles tendon loading activities (e.g. walking, running) Ankle joint examination is normal and passive plantar-flexion is painfree; Confirm diagnosis with ultra .... Read more
• Previous rSWT treatment for any condition • Previous Achilles tendon surgery in the most symptomatic Achilles tendon • Previous Achilles tendon rupture in the most symptomatic Achilles tendon • Other ankle conditions including impingement syndrome or any midportion Achilles symptoms that are worse than the insertional Achilles pain • Tendinopathy caused by inflammatory conditions (e.g. ankylosing spondylitis) • Neurological disorders (i.e. Parkinson’s syndrome, stroke) • Inherited connective t .... Read more
No
Sample Size 76
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Tendinopathy
Condition code Musculoskeletal , Physical Medicine / Rehabilitation
Intervention code Treatment: Devices , Treatment: Other
Radial shockwave therapy (rSWT): rSWT will be administered by an adequately trained physiotherapist. The participant will receive a 3000-shock dose of rSWT (Chattanooga device) applied to the most painful area on the affected side Achilles tendon. Gel will be used to conduct pressure waves to the tendon. Intensity of application will start on two bars of pressure, with frequency set to continuous and eight per second. The target self-reported pain will be >4/10 until the highest tolerable pain ( .... Read more
Control group Placebo
Sham rSWT: This procedure is identical to the rSWT, but without any pressure waves entering the body and without the production of a pain response. The sham rSWT device will appear and sound identical to the active rSWT device.. All other aspects of the intervention including follow-up sessions, 6 week Zoom meeting, weekly email support and the exercise and education interventions will be identical in both groups.
Outcome: Pain and function will be assessed with VISA-A score (this is a composite instriment measuring both pain and function). The VISA-A is a disease specific and validated tool for assessing Achilles tendon pain and function.Timepoint: baseline in person and 6 and 12 (primary endpoint) weeks via email or text link to online questionnaire.
yes
All outcome data
After the end of data analysis, so after Sept 2020 (for a period of 5 years)
Upon request. Data will be shared with researchers who provide a sound methodological proposal (e.g. protocol for a systematic review).
Systematic review