Postural Training Device (UPRIGHT) for Back Pain
Addition of Postural Training Device (UPRIGHT) to Routine Physical Therapy for the Treatment of Back Pain: a Randomized Trial
研究概览
详细说明
Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device.
Physical therapy will be completed 1-2 times per week over 4-6 weeks. If randomized to the group that also receives a postural training device, one of the physical therapy sessions will instruct the patient on use of the device, which can be used thereafter as tolerated by the patient.
At 6 weeks and 3 months, questionnaires that assess patients pain and function will be completed to assess outcomes
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Tennessee
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Nashville、Tennessee、美国、37212
- Vanderbilt University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 - 65, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, and capable of attending all planned therapy sessions
- Primary complaint of lumbar or thoracic pain thought to be at least in part due to mechanical/postural etiologies based on clinical presentation
- 7 day average numeric pain rating score (NPRS) of at least 4 on a 0-10 scale at baseline evaluation
- Pain duration of at least 2 months
- Patient owns and is familiar with the use of a personal smart phone
- Patient consents to treatment with postural based physical therapy. In order to maintain blinding, patients will not be provided with details of the treatment plan until after the randomization process has been performed. They will only be informed of the treatment protocol for the group to which they have been assigned.
Exclusion Criteria:
*History of prior thoracic or lumbar fusion surgery
- Acute Spine fracture
- Current pregnancy
- BMI over 40
- Inability to sense UPRIGHT vibration
- Active Systemic inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing spondylitis, lupus)
- Medical conditions causing significant functional disability (e.g. stroke, spinal cord injury, amputation)
- Severe Chronic widespread pain or somatoform disorder (e.g. fibromyalgia)
- Severe clinical depression, or psychotic features
- Implanted electrical medical device (i.e. cardiac pacemaker/defibrillator, spinal cord stimulator, bladder stimulator)
- Allergic skin reaction to tapes or adhesives
- Worker's compensation claim or legal action related to the thoracic or lumbar pain
- Patients unable to read English and complete the assessment instruments
- Patients unable to attend assigned physical therapy sessions
- Incarcerated patients
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Physical Therapy
Receive standard physical therapy
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routine physical therapy
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实验性的:posture training device
Receive a posture training device in addition to standard physical therapy
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A small externally wearable device that is placed on the back, which gently vibrates when correct posture is not maintained.
The device is removable, and used for only portions of the day
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement/Change in Pain
大体时间:Primary outcome is at 6 weeks, secondary time point 12 weeks
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0-10 pain scale
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Primary outcome is at 6 weeks, secondary time point 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement/Change Disability
大体时间:6 weeks, 12 weeks
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Modified Oswestry Disability Index
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6 weeks, 12 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
背痛,低的临床试验
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The First Affiliated Hospital with Nanjing Medical...Zhejiang Cancer Hospital; RenJi Hospital; The First Hospital of Jilin University; The Affiliated... 和其他合作者招聘中
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University招聘中
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完全的
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Sun Yat-sen University招聘中
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University招聘中
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Renske AltenaKarolinska Institutet; Affibody招聘中
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Daiichi Sankyo招聘中
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Sichuan Baili Pharmaceutical Co., Ltd.Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.招聘中
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Cancer Institute and Hospital, Chinese Academy...招聘中
physical therapy的临床试验
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
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Abbott Medical Devices完全的