None listed
Conditions
Brief summary
The primary aim of this research project is to investigate whether the way we report clinical imaging findings impacts patient perception of treatment efficacy in midsubstance Achilles tendinopathy. This study is a parallel group, randomised controlled trial with an 8-week follow-up. Participants will be randomised into receiving a standard imaging report based on conventional imaging practice or an evidence-based imaging report with the aim of stating that their imaging does not reflect their clinical symptoms. Both groups will receive a one-on-one explanation of their imaging explaining that imaging does not reflect their clinical symptoms. Primary and secondary measures will be collected at baseline, 4 and 8 weeks. The primary outcome measures are 7-point patient global impression of change and the Tampa scale of kinesiophobia. Secondary outcome measures are the VISA-A score and severity of pain during the previous week.
Interventions
Evidence-based imaging report: Four weeks following participation in the linked 12 week RCT (heel lift or eccentric exercise) for midsubstance Achilles tendinopathy, this study will send participants a report via email summarising the ultrasound imaging findings from their scans undertaken at the end of the 12 week trial.
The evidence-based imaging group will receive a report 4 weeks after the end of the linked trial, that places their imaging findings in a context of what is within normal appe
Evidence-based imaging report: Four weeks following participation in the linked 12 week RCT (heel lift or eccentric exercise) for midsubstance Achilles tendinopathy, this study will send participants a report via email summarising the ultrasound imaging findings from their scans undertaken at the end of the 12 week trial. The evidence-based imaging group will receive a report 4 weeks after the end of the linked trial, that places their imaging findings in a context of what is within normal appearances for their age and activity. The evidence-based imaging report will be on a standardised report template that places the context of current research evidence. It will outline the following parameters: -While their tendon is pathological, 30% of the population have a similar looking tendon yet have never had pain. -State the dimensions (mm2) of aligned fibrillar structure (ie healthy tendon) in comparison to structurally normal tendon -State maximum tendon thickness in comparison to a structurally normal Achilles tendon, suggesting that is has compensated for the area of disorganisation -Include a transverse and sagittal image of their Achilles tendon in comparison to a structurally normal tendon Both groups will receive a one-on-one interview 4 weeks after receiving the imaging report with investigators (experienced researcher with a PhD who specialises in tendon imaging), where their imaging findings will be explained in the context of current research. This consultation will last between 15 and 30mins. The following concepts will be explained to participants in both groups: -Up to 30% of pain-free individuals have a pathological tendon similar to theirs. -The presence of pathology is not the reason they had pain, nor is it the reason that they may still have pain. -The amount of disorganisation (ie the hypoechoic area) is not a barrier to clinical improvement. No measure on imaging has been show to be prognostic for clinical improvements following treatment -While their tendon has remained pathological, it does not need to remodel to result in clinical improvements following treatment. Their tendon has found its 'happy place' where it is able to tolerate load with this amount of disorganisation and does not need to remodel to normal -A thick tendon is a good tendon. That the thickened tendon indicates that it has adapted to compensate for the area of disorganisation.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The key inclusion criteria for this study is participation and completion in the registered RCT "The effectiveness of heel lifts versus calf muscle eccentric exercise for Achilles tendinopathy: a randomised controlled trial" (ACTRN12617001225303) The inclusion criteria for this linked study were: (a) Aged 18 years or greater. (b) Achilles tendon pain present in one or both lower limb(s) for a minimum of 2 months. (c) Report having average daily pain during the past week rated at least 3 out of 10 on a numerical rating scale. (d) Mid-portion Achilles tendinopathy in one or both lower limb(s). Mid-portion Achilles tendinopathy will be diagnosed based on a clinical assessment and musculoskeletal ultrasound. Respondents will be included in this study if they meet the following criteria: (i) insidious onset of pain in the region of the Achilles tendon, aggravated by weight bearing activity; (ii) pain located 2 to 6 cm proximal to the Achilles tendon insertion upon palpation by the investigator; (iii) musculoskeletal ultrasound of the Achilles tendon showing local thickening, irregular fibre orientation or hypoechoic areas; (iv) Literate in English and able to complete the questionnaires used in this study (such as the primary outcome measure - Victorian Institute of Sport Assessment – Achilles (VISA-A) questionnaire). (v) Regularly use footwear that can accommodate a heel lift of 12 mm height. (vi) Able to walk household distances (more than 50 m) without the aid of a walker, crutches or cane. (vii) Willing to attempt to not receive additional treatments (such as shoe modifications, physiotherapy, foot orthoses/bracing, injections, or surgery) for the Achilles pain during the course of the study (12 weeks). (viii) Willing to attempt to discontinue taking all pain-relieving medications to relieve pain for the Achilles tendon(s) (except paracetamol) for at least 14 days prior to the initial assessment and during the study period (12 weeks). (ix) Willing to attend the Health Sciences Clinic at La Trobe University (Melbourne, Victoria) for an assessment on three occasions and complete and complete and return a postal questionnaire on one occasion. The additional key inclusion criteria for this current study being registered are: (a) musculoskeletal ultrasound of the Achilles tendon showing local thickening, irregular fibre orientation or hypoechoic areas at the end of the intervention. (b) Willing to attend the Health Sciences Clinic at La Trobe University (Melbourne, Victoria) for an assessment on one occasion, and return a postal/electronic questionnaire on one occasion.
Exclusion criteria
The exclusion criteria for participants in linked study were: (i) Currently pregnant. (ii) Previous Achilles tendon surgery in the symptomatic lower limb(s). (iii) Previous Achilles tendon rupture in the symptomatic lower limb(s). (iv) Chronic ankle instability. (v) Conditions of the Achilles tendon / ankle region that are not mid-portion Achilles tendinopathy such as ankle osteoarthritis, impingement syndrome, insertional Achilles tendinopathy, Achilles paratenonitis. (vi) Inflammatory arthritis (e.g. ankylosing spondylitis). (vii) Metabolic or endocrine disorders (e.g. type I or type II diabetes). (viii) Neurological disorders (e.g. Charcot-Marie-Tooth disease). (ix) Previous breast cancer and/or use of oestrogen inhibitors. (x) Treatment with heel lifts or calf muscle eccentric exercise within the previous three months. (xi) Use of fluoroquinolone antibiotics within the previous two years. (xii) Injection of local anaesthetic, corticosteroid or other pharmaceutical agent into the Achilles tendon or surrounding area within the previous three months. (xiii) Any medical condition that, in the opinion of the investigators, makes the participant unsuitable for inclusion (e.g. clinically important pain in the musculoskeletal system other than the Achilles tendon). (xiv) Cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire). For the current proposed study, the key exclusion criterion is: (a) having not participated and completed the registered RCT "The effectiveness of heel lifts versus calf muscle eccentric exercise for Achilles tendinopathy: a randomised controlled trial" (ACTRN12617001225303)
Outcome results
None listed