ISRCTN37543220已完成未知
An assessment of the effects Footjack flat orthotic on (1) the foot, lower limbs, pelvis, and spine compared to a control and a standard arch support and (2) on pain and function in subjects with pes planus and chronic low back pain over a 7 month period compared to a control with random allocation
Footjacks Limited0 个研究点目标入组 59 人开始时间: 2017年8月23日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Wearing arm:
- •1. Age 18-75
- •2. Iliac crests not level with easy normal standing with feet straight and iliac crests level or substantially level when standing on lateral calcanei
- •3. Chronic low back pain (three episodes of back pain in the last 24 months with pain at the time consent taken) below T12, including lumbar spine and pelvic joints with or without radiating pain
- •Measuring arm:
- •1. Age 18 to 75
- •2. Iliac crests not level by at least 1.5 degrees with easy normal standing with feet straight and iliac crests level or substantially level when standing on the lateral calcanei
排除标准
- •Wearing arm:
- •1. Under 18 and over 75
- •2. No history of chronic low back pain
- •3. Lack of suitability for whatever clinical reason to be randomised (any condition in the opinion of the Investigator would make it unsafe or unsuitable for the patient to participate in the study)
- •4. Person unable to give consent
- •5. Vulnerable people
- •6. Patient with any musculoskeletal condition making it difficult for the spine to adapt to a change, e.g. spinal fusion in the neck, disc herniation threatening the cord, severe spinal stenosis etc. Subject will complete a case history at the assessment stage of the trial and excluded if unsuitable for the trial due to such a condition
- •7. Severe sciatica with neurological signs
- •9. Pregnancy or planned pregnancy
- •10. Severe osteoarthritis of lower limb joints
- •11. Inflammatory arthritis
- •12. Recent or complicated fractures
- •13. Congenital lower limb deformity
- •14. Undertaking a course of medical treatment or physical therapy of more than 1 a month that could interfere with the validity of the trial data
- •15. Foot pathology which interferes with levelling of the pelvis
- •16. Already wearing standard arch supports
- •17. Progressive and/ or severe multiple sclerosis
- •Measuring arm:
- •1. Musculoskeletal system is unable to adjust to changes in movement through the lower limb, pelvis and spine
- •2. Subjects being unlevel at the iliac crests of less than 1.5 degrees using the Palm Inclinometer
- •3. A congenital lower limb deformity
- •4. Any balance problem making difficult to stand on one leg
- •5. Anyone who is unable to follow the necessary instructions. They will not be excluded if they have a family member who can explain/translate
研究者
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