ACTRN12621000846820尚未招募未知
A Pilot Randomised Trial Comparing Individualised Physiotherapy versus Shockwave Therapy for Proximal Hamstring Tendinopathy
aTrobe University0 个研究点目标入组 100 人开始时间: 2021年7月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
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 65 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •Initial Phone Screening
- •1.Reports of relatively localised (defined as an area smaller than a tennis ball) ischial tuberosity region pain of gradual onset and at least 3 months in duration.
- •2.Willingness to participate in six sessions of intervention over a 12-week period.
- •3.Age between 18 and 65 inclusive.
- •4.Fluency in English sufficient to complete questionnaires and to enable understanding to the intervention.
- •5.Agreeing to refrain from other interventions for the treatment period of the trial, aside from consultation with medical practitioners, and medication.
- •6.Planned absence for a period of >2 weeks during the treatment period (such as overseas holiday).
- •Clinical examination screening
- •7.A clear increase in activity levels precipitating onset of symptoms determined based on clinical interview.
- •8.Positive findings (reproduction of lower buttock pain) with three or more of four diagnostic criteria:
- •oSingle-leg arabesque
- •oSupine single leg bridge with heel on standardised height platform (bent knee)
- •oSelf reported PHT symptoms with prolonged sitting <30 minutes.
- •oModified bent-knee hamstring stretch test.
排除标准
- •Exclusion Criteria
- •Initial Phone Screening
- •1.Previous surgery to the hamstring complex, as we wish to study treatment effects independent to the effects of surgical procedures.
- •2.Previous injection to the hamstring tendon within the previous 6 weeks, as we wish to study treatment effects independent to the effects of injections.
- •3.Treatment with ESWT for PHT in the last 3 months, as we wish to study treatment effects independent to the effects of ESWT.
- •4.Contraindications to receiving ESWT.
- •5.Current pregnancy, or recent childbirth (within 6 months) as this could impair ability to undertake testing and intervention.
- •6.Diagnosis with autoimmune disease as we do not wish to evaluate tendon response where there is a potential autoimmune influence
- •7.Already received more than two sessions of physiotherapy with any of the trial physiotherapists prior to enrolment, as these therapists are likely to use many components of the trial treatment protocol on their clinical caseload.
- •8.An active compensation claim for the injury, as this may have a negative influence on the response to treatment.
- •Clinical examination screening
- •9.Pain that is predominantly due to lumbar dysfunction including lumbar spine radiculopathy, or lumbar spine somatic referral
- •10.Pain that is reasoned from clinical examination to be predominantly due to other structures or conditions, including sciatic nerve entrapment, ischiofemoral impingement, hip joint, local sciatic nerve irritation, and adductor magnus tendinopathy
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