Paraspinal Stimulation in Treating MPS (DIMMST)
2012年10月15日 更新者：Wolnei Caumo、Hospital de Clinicas de Porto Alegre
Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation in Treating Myofascial Pain: Randomized Sham-controlled Clinical Trial
To test the hypothesis that the effect of either multiple deep intramuscular stimulation therapy [(DIMMST: trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR)] would be more effective than a placebo-sham for the treatment of MPS and that DIMMST would be more effective than LTrP-I for improving pain relief, sleep quality, and physical and mental state of the patient.
研究概览
研究类型
介入性
注册 (预期的)
75
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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RS
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Porto Alegre、RS、巴西、90035-003
- 招聘中
- Hospital de Clínicas de Porto Alegre
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接触：
- José R Goldim, PhD
- 电话号码：55 (51) 3359-8856
- 邮箱：jrgoldim@gmail.com
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首席研究员：
- Wolnei Caumo, MD., PhD
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副研究员：
- IRACI LS TORRES, PhD
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副研究员：
- FELIPE GREGNI, PhD
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Porto Alegre、RS、巴西、90035-003
- 招聘中
- Hospital de Clínicas E Porto Alegre
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接触：
- JOSE GOLDIM, PhD
- 电话号码：55 (51) 3359-8856.
- 邮箱：jrgoldim@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion criteria
- Myofascial pain syndrome (MPS) (defined as regional pain, normal neurologic examination, presence of TrPs, taut bands, tender points, and pain characterized as "dull," "achy," or "deep" were relevant to MPS diagnosis. Additionally, palpable nodules, pain that is exacerbated by stress, decreased range of motion, and ropiness in the muscle).
- Disability in the last three months: (defined if they had one or more these limitation in active and routine activities by MPS : (i) interference with work, (ii) enjoyable activities, (iii) responsibilities at home, (iv) relationships, (v) personal goals, (vi) thinking clearly, and problem solving, concentrating, or remembering during the last three months).
- Women
- Age: 19 to 50 years
Exclusion criteria
Rheumatoid arthritis
Fibromyalgia
Previous surgery on the affected areas
Prior experience with acupuncture
Primary radiculopathy
Current use of psychotropic drugs (ilicits
) Habitual use of anti-inflammatory steroids.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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假比较器：Placebo-sham
Placebo-sham twice a week during four weeks
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其他名称：
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有源比较器：Lidocaine injection
Lidocaine 0.2-0.5 mL of 1% injected each time into the trigger point.
Twice a week during four weeks
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其他名称：
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实验性的：DIMMST
DIMMST include the combination of trigger point deep dry needling (TrP-DDN) is combined with paraspinal deep intramuscular stimulation (PDIMS) and needle rotation (NR). Twice a week during four weeks |
其他名称：
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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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Pain severity
大体时间：A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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a) The intensity of pain was measured by a 10-cm VAS [30].
VAS scores ranged from no pain (zero) to the worst possible pain (10 cm).
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A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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Pain threshold
大体时间：A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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Pain pressure threshold (PPT)
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A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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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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Sleep quality - how did you feel when you woke up
大体时间：A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS: In general, how did you feel when you woke up? |
A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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Sleep quality - compared to your habitual sleep
大体时间：A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS: Assess the sleep quality of the previous night compared to your habitual sleep? |
A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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Sleep quality -last night
大体时间：A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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Sleep quality was recorded daily by the 10-cm visual analog sleep quality scale (VASQS) in the sleep diary using VASQS: How well did you sleep last night? |
A cumulative mean of each week during the treatmetn period (four weeks - the pain diary begin in the first of treatment to the last session)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physical and mental Health
大体时间：Before to begin treatment and after end treatment
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Health-related quality of life, assessed at baseline and the end of treatment sessions, was measured with the SF-12 Summary Scales
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Before to begin treatment and after end treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (预期的)
2012年11月1日
研究完成 (预期的)
2012年11月1日
研究注册日期
首次提交
2012年10月9日
首先提交符合 QC 标准的
2012年10月15日
首次发布 (估计)
2012年10月16日
研究记录更新
最后更新发布 (估计)
2012年10月16日
上次提交的符合 QC 标准的更新
2012年10月15日
最后验证
2012年10月1日
更多信息
与本研究相关的术语
其他研究编号
- MPS-DIMS
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.