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仪器辅助与声音辅助软组织松动术在慢性非特异性腰痛中的治疗效果 (IASTM VS SASTM)

2026年9月30日 更新者:Tahir Mahmood、University of Lahore

器械辅助与声波辅助软组织松动术对慢性非特异性腰痛患者的治疗效果

Chronic low back pain (CLBP) is the most common medical problem observed among musculoskeletal pain and spinal pain problems. It can reduce the movements due to muscular imbalances, decreased activity of daily living, and effects on health-related quality of life. It is the major cause of activity limitation, work absence, and reported clinical issues. Most of the cases of low back pain remained undiagnosed and received only symptomatic management.

研究概览

详细说明

There is limited literature on advanced soft tissue release techniques provided by primary healthcare practitioners specific to low back pain. Some of the studies are based on soft tissue mobilization using a mechanically assisted method, but they have limited outcomes, acute effects, and small sample sizes, which limit their generalization. Further literature is limited in the comparison of IASTM and SASTM. Further, there are limited techniques that can facilitate practitioners to identify the restrictions.

Firstly, instrument-assisted soft tissue mobilization (IASTM), due to its body contour and shape, recognizes specific tissue lesions and restriction sites while targeting specific points rather than using manual methods that cover a larger contact area. Using the mechanotransduction phenomenon, its mechanical stimuli initiate biochemical signals that trigger cellular responses and ultimately functional improvement. Biomechanically, fascial elasticity, fascial stiffness, and viscosity absorb and distribute forces. While tissue hydration level is increased, that is compromised in chronic low back pain.

Secondly, sound-assisted soft tissue mobilization could be an intervention for treating musculoskeletal disorders. The SASTM technique has the potential to be a game-changer in pain management after IASTM. The sound decreases as adhesions are broken. While breakdown of scar tissue can be a facilitator for ease of movement patterns.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

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

    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦、54000
        • Arif Memorial Teaching Hospital
      • Lahore、Punjab Province、巴基斯坦、54000
        • Re Active Physio Clinic Lahore.

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

40年 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Pain between the inferior gluteal folds and the costal margins.
  • Pain with a duration of a minimum of 24 weeks.
  • Moderate to severe pain (>3) was measured using the Numeric Pain Rating Scale.
  • Straight Leg raise Limited (hamstring tightness)

Exclusion Criteria:

  • Pain in lower back with radiating/referring but limited to proximal legs
  • Pain for the last 03 months and at least half of the days in the last six months.
  • Presence of neurological problem/deficit/disease (e.g., nerve root compression, motor deficit, paresthesia) and lower limb symptoms.
  • Presence of disease like Infection, tumors, spondylolisthesis grade II or higher, vertebral fractures, identifiable cause like endometriosis
  • Medicine like immunosuppression or steroid medication;
  • Spinal deformities
  • History of severe rheumatic, orthopedic, or cardiovascular disease in the last three months before study participation.
  • Previously diagnosed Osteoporosis
  • SIJ dysfunction is evaluated by a positive compression test.
  • BMI over 35.
  • Skin allergy or hypersensitivity that can lead to skin irritation due to IASTM/SASTM tools.

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:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group A

Group A (IASTM + Conventional therapy)

The IASTM technique contains a protocol for treatment that contains five components: i. Examination, ii. warm-up exercises 5 min iii. IASTM treatment (e.g., 30-60 seconds per session), iv. Post treatment stretching and strengthening, v. Icing (only when sub-acute inflammation is of concern).

In conventional therapy, patients will be given an exercise program that will be targeted to low back muscles. This will be include three type of exercise focusing on stretching, strengthening and postural correction exercise.(Yana et al., 2024)

实验性的:Group B

Group B (SASTM + Conventional)

In conventional therapy, patients will be given an exercise program that will be targeted to low back muscles. This will be include three type of exercise focusing on stretching, strengthening and postural correction exercise.(Yana et al., 2024)

The therapist will apply sound instrument-assisted soft tissue mobilization (SASTM) with a convex plastic (Ceramic) tool (Beer JA, 2019).

其他:Group C

Conventional therapy

In conventional therapy, patients will be given an exercise program that will be targeted to low back muscles. This will be include three type of exercise focusing on stretching, strengthening and postural correction exercise.(Yana et al., 2024)

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
Pain Intensity
大体时间:Pain intensity will be noted at baseline ,after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.

The pain will be assessed using Chronic Pain grading Scale (CPGS).

Pain intensity will be noted at baseline ,after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.
Flexibility
大体时间:The lumbar flexibility will be noted at basline after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.

Modified-Modified Schober Test will be used to measure Lumbar flexibility.

The lumbar flexibility will be noted at basline after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.

次要结果测量

结果测量
措施说明
大体时间
Function
大体时间:The functional movement screening will be noted at baseline, after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.

Functional movement Screen (FMS) will be used.

The functional movement screening will be noted at baseline, after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.
Disability
大体时间:Disability will be assessed before treatment, after the 2nd month, and 4th month post-intervention.

Roland Morris Disability Index will be used to measure disability Index.

Disability will be assessed before treatment, after the 2nd month, and 4th month post-intervention.
Hamstring Flexibility
大体时间:Hamstring flexibility will be measured at basline, 2nd month, and after the 4th month post intervention.

Active knee Extension Test will be used to assess hamstring Flexibility.

Hamstring flexibility will be measured at basline, 2nd month, and after the 4th month post intervention.

其他结果措施

结果测量
措施说明
大体时间
Pelvic obliquity
大体时间:The pelvic obliquity will be assessed before treatment, after 2nd month and 4th month post-intervention.

Leg length difference will be measured as an indicator of pelvic obliquity.

The pelvic obliquity will be assessed before treatment, after 2nd month and 4th month post-intervention.

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (实际的)

2025年12月23日

初级完成 (实际的)

2026年5月9日

研究完成 (实际的)

2026年9月15日

研究注册日期

首次提交

2025年11月17日

首先提交符合 QC 标准的

2025年11月17日

首次发布 (实际的)

2025年11月24日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

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.

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