The effect of imaging reports on patient perceptions of treatment in patients with Achilles tendinopathy

Not Applicable

Completed

• Conditions: Midsubstance Achilles tendinopathy; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12618000097246
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Study Completion: 2018-05-25
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient global impression of change (PGIC) 7-point likert scale for pain. The scale will ask participants 'compared to how you were before started the treatment (either eccentric loading or heel lifts), how is your pain in your Achilles tendon(s)?' and include the following responses 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', or 'very much worse'. [Baseline (at the end of the 12 week exercise and heel raise intervention), 4 weeks (primary timepoint), and 8 weeks.];The patients level of fear of movement will be evaluated using the English version of Tampa scale of kinesiophobia. This questionnaire contains 11 items, where patients answers whether they agree or disagree with the statement on a 4-point Likert scale. A score ranging from 11-44 is calculated, where a high score indicates a high level of kinespiophobia[Baseline (at the end of the 12 week exercise and heel raise intervention), 4 weeks (primary timepoint), and 8 weeks]

Secondary Outcome Measures

Name	Time	Method
The Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A) is a standardised measure for Achilles tendinopathy and will be used to assess pain, function, and physical activity. It includes 8 questions, questions 1-6 use a 0-10 numerical rating scale, where questions 7-8 are multiple-choice. A total score out of 100 is calculated, with a low score indicating high level of pain and dysfunction. [Baseline (at the end of the 12 week exercise and heel raise intervention), 4 weeks, and 8 weeks];Severity of pain at the Achilles tendon will be measured using a 100 mm VAS, where participants will be asked ‘Please mark on the line the severity of pain you have experienced in your Achilles tendon(s) when it has been at its worst, over the past week’. The VAS will have the following anchors: zero (0) indicated 'no pain' and one hundred (100) indicates 'worst pain imaginable'.[Baseline (at the end of the 12 week exercise and heel raise intervention), 4 weeks, and 8 weeks]