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临床试验/NCT07244913
NCT07244913招募中不适用

Therapeutic Effects of Instrument-assisted Versus Sound-assisted Soft Tissue Mobilization Among Patients With Chronic Non-specific Low Back Pain

University of Lahore2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Pain Intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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.
  • •Skin allergy or hypersensitivity that can lead to skin irritation due to IASTM/SASTM tools.

研究组 & 干预措施

Group B

Experimental

Group B (SASTM + Conventional)

干预措施: SASTM (Device)

Group B

Experimental

Group B (SASTM + Conventional)

干预措施: Exercise (Other)

Group A

Active Comparator

Group A (IASTM + Conventional therapy)

干预措施: IASTM (Device)

Group A

Active Comparator

Group A (IASTM + Conventional therapy)

干预措施: Exercise (Other)

Group C

Other

Conventional therapy

干预措施: Exercise (Other)

结局指标

主要结局

Pain Intensity

时间窗: 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).

Flexibility

时间窗: 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.

次要结局

  • Function(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(Disability will be assessed before treatment, after the 2nd month, and 4th month post-intervention.)
  • Hamstring Flexibility(Hamstring flexibility will be measured at basline, 2nd month, and after the 4th month post intervention.)

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tahir Mahmood

PhD Scholar

University of Lahore

研究点 (2)

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