scholarly journals Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy: a protocol for a randomised controlled trial

2021 ◽  
Vol 7 (4) ◽  
pp. e001136
Author(s):  
Peter Malliaras ◽  
David Connell ◽  
Anders Ploug Boesen ◽  
Rebecca S Kearney ◽  
Hylton B Menz ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
High Volume ◽  
Primary Outcome Measure ◽  
Achilles Tendinopathy ◽  
Double Blind ◽  
Sham Injection ◽  
Intention To Treat ◽  
Randomised Controlled

IntroductionAchilles tendinopathy (AT) is a common and disabling musculoskeletal condition. First-line management involving Achilles tendon loading exercise with, or without, other modalities may not resolve the problem in up to 44% of cases. Many people receive injections. Yet there are no injection treatments with demonstrated long-term efficacy. The aim of the trial is to examine the 12-month efficacy of high-volume injection (HVI) with corticosteroid and HVI without corticosteroid versus sham injection among individuals with AT.Methods and analysisThe trial is a three-arm, parallel group, double-blind, superiority randomised controlled trial that will assess the efficacy of HVI with and without corticosteroid versus sham up to 12 months. We will block-randomise 192 participants to one of the three groups with a 1:1:1 ratio, and both participants and outcome assessors will be blinded to treatment allocation. All participants will receive an identical evidence-based education and exercise intervention. The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function. Choice of secondary outcomes was informed by core outcome domains for tendinopathy. Data will be analysed using the intention-to-treat principle.Ethics and disseminationEthics approval was obtained via the Monash University Human Ethics Committee (no: 13138). The study is expected to be completed in 2024 and disseminated via peer review publication and conference presentations.Trial registration numberAustralia and New Zealand Clinical trials registry (ACTRN12619001455156)

Physiotherapist-delivered stress inoculation training integrated with exercise versus physiotherapy exercise alone for acute whiplash-associated disorder (StressModex): a randomised controlled trial of a combined psychological/physical intervention

2019 ◽  
Vol 53 (19) ◽  
pp. 1240-1247 ◽  
Author(s):  
Michele Sterling ◽  
Rob Smeets ◽  
Gerben Keijzers ◽  
Jacelle Warren ◽  
Justin Kenardy
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Stress Inoculation ◽  
Stress Inoculation Training ◽  
Intention To Treat ◽  
Poor Recovery ◽  
Randomised Controlled

ObjectiveThere are few effective treatments for acute whiplash-associated disorders (WAD). Early symptoms of postinjury stress predict poor recovery. This randomised controlled trial (StressModex) investigated whether physiotherapist-led stress inoculation training integrated with exercise is more effective than exercise alone for people with acute WAD.Methods108 participants (<4 weeks) at risk of poor recovery (moderate pain-related disability and hyperarousal symptoms) were randomly assigned by concealed allocation to either physiotherapist-led stress inoculation training and guideline-based exercise (n=53) or guideline-based exercise alone (n=55). Both interventions comprised 10 sessions over 6 weeks. Participants were assessed at 6 weeks and at 6 and 12 months postrandomisation. Analysis was by intention to treat using linear mixed models.ResultsThe combined stress inoculation training and exercise intervention was more effective than exercise alone for the primary outcome of pain-related disability at all follow-up points. At 6 weeks, the treatment effect on the 0–100 Neck Disability Index was (mean difference) −10 (95% CI −15.5 to −4.48), at 6 months was −7.8 (95% CI −13.8 to −1.8) and at 12 months was −10.1 (95% CI −16.3 to −4.0). A significant benefit of the stress inoculation and exercise intervention over exercise alone was also found for some secondary outcomes.ConclusionA physiotherapist-led intervention of stress inoculation training and exercise resulted in clinically relevant improvements in disability compared with exercise alone—the most commonly recommended treatment for acute WAD. This contributes to the case for physiotherapists to deliver an early psychological intervention to patients with acute WAD who are otherwise at high risk of a poor outcome.Trial registration numberACTRN12614001036606.

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