ACTRN12618000097246已完成未知
The effect of imaging reports on patients perception of treatment efficacy in patients with midsubstance Achilles tendinopathy: A randomised clinical trial
a Trobe University0 个研究点目标入组 31 人开始时间: 2018年1月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Educational / counselling / training
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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)
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