ACTRN12624000260527招募中Unknown
Efficacy of shockwave therapy for pain in participants with a bone marrow lesion phenotype of chronic plantar heel pain: the BALSA trial.
Menzies Institute for Medical Research, University of Tasmania0 个研究点目标入组 90 人开始时间: 2024年3月15日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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
- Treatment
- 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
- •Inclusion: (i) aged >=18yrs, (ii) pain under the heel on most days aggravated by weightbearing, for at least 3 months, (iii) pain level > 30 on a 100mm pain visual analogue scale (VAS, 0 no pain, 100 worst possible pain), (iv) plantar calcaneal BML on PD-FS sagittal MRI > 22mm^2 (22mm^2 is the Least Significant Change, as calculated from our preliminary data).
排除标准
- •Exclusion: (i) other lower limb pain or injury affecting mobility or participation in the past 3 months, (ii) past foot surgery or fracture involving the ankle, hind or midfoot, excluding avulsion injuries confirmed on X-ray, (iii) injection into the heel in last 3 months (iv) previous shockwave treatment, (v) diabetes or inflammatory disease, (vi) fibromyalgia, (vii) contraindication to MRI^, (viii) currently receiving professional treatment*, (ix) lower limb neurological disease, (x) vascular disease affecting lower limbs, (xi) sciatica in last 6 months, (xii) contraindication to having shockwave treatment (Table 1), (xiii) past or current bisphosphonate use, and (xiv) unwilling or unable to commit to full treatment course or complete questionnaires online.
- •*Discontinuing current treatment with a 2-week washout for non-steroidal anti-inflammatory use, 6-weeks for glucocorticoid use, or 3-week wash-out for conservative professional interventions such as manual therapy, would void this exclusion. Participants who maintain a stable approach in the preceding 6 weeks to ongoing self-administered treatments such as footwear or orthotic use or exercise, may continue with those interventions and maintain eligibility.
- •^Although not an absolute contra-indication, we will exclude pregnant participants. If there is any doubt about pregnancy status we will request participants undergo a urine pregnancy screening test before proceeding to MRI.
- •Table 1. Contraindications to shockwave therapy
- •Anti-coagulant therapy, haemhorrhagic conditions
- •Local infection
- •Wound/ skin lesions
- •Impaired circulation/ ischaemic conditions
- •Prosthetic device in treatment area
研究者
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