ACTRN12620000906954已完成未知
Treatment of Medial Tibial Stress Syndrome using anInvestigational Lower Leg Device. A RandomisedControlled Trial Investigating Pain Severity and Return to Sport.
William McNamara0 个研究点目标入组 14 人开始时间: 2020年9月14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
- 14
研究概览
简要总结
Comparison of MTSS Severity Scores between groups from 5-24 weeks demonstrated a significantly lower score in the device group (p < 0.03). Comparison within the placebo group did not demonstrate a statistically significant difference at any time point (p > 0.05) and the device group yielded a significant reduction in MTSS severity from 0-5 weeks (p < 0.03), 0 to 12 weeks (p < 0.03), and 0-24 weeks respectively (p < 0.03). Ordinal logistic regression analysis did not identify any significant confounders.
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
- •Symptomatic medial tibial stress syndrome of at least 6 weeks duration, diagnosed on the basis of:
- •oHistory of diffuse, dull shin pain that is associated with exercise,
- •oPalpable tenderness of the posteromedial tibial border
排除标准
- •Diagnosis of stress fracture in the previous 6 months
- •Clinical suspicion of a current stress fracture due to localised point tenderness on the anterior or medial border of the tibia unless ruled out by an MRI (MRI negative for bone stress reaction)
- •Signs of plantar fasciitis including heel pain on first steps in the morning and tenderness to palpation over the posteromedial calcaneal tuberosity
- •Previous diagnosis of compartment syndrome
- •Suspicion of chronic exertional compartment syndrome on the basis of history of shin or calf pain brought on at a predictable point in activity, that worsens if exercise continues and is relieved by rest, unless excluded with compartment pressure testing
- •Clinical signs of complex regional pain syndrome including pain out of proportion to the inciting event, allodynia, hyperalgesia, diffuse oedema, skin changes and difference in temperature between limbs
- •Previous diagnosis of popliteal artery entrapment syndrome
- •Clinical suspicion of popliteal artery entrapment syndrome based on disappearance of pedal pulses on repetitive plantarflexion
- •Clinical suspicion of radicular leg pain including history of back pain associated with the leg pain and/or reproduction of leg pain on SLR testing with added dorsiflexion
- •Neurological disease affecting the lower leg
- •Coagulation disease
研究者
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