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临床试验/NCT03940313
NCT03940313已完成不适用

Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain

ProloAustin1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
MSK Ultrasound

研究概览

简要总结

This is a prospective study on chronic low back pain patients aimed at investigating how findings on a physical examination and musculoskeletal ultrasound may correlate with myofascial damage in the lower back. By comparing these findings with a control group and collecting follow up data on patients treated in the course of normal clinical practice, the investigators will be able to discern if fascial pathology contributes to chronic low back pain and if this treatment approach may provide clinical benefit to patients in the form of pain reduction and/or reduction in pain medication use.

详细描述

This is a prospective, observational clinical study that will be run through a private practice clinic.

New patients to the clinic that complain of chronic lower back pain will be evaluated for inclusion and exclusion criteria and appropriately recruited and enrolled into the study. The baseline evaluation will take approximately 1.5hours to complete, and will include the following: a standardized pain scale questionnaire; a baseline questionnaire that assesses duration of current pain and previous interventions; physical examination with novel techniques to assess strength; and musculoskeletal ultrasound in the lower back.

Specific physical examination techniques will assess strength of the subject on both prone straight leg raise as well as hip external rotation. Then, the investigators will test how adding myofascial tension along the lower back may affect these results. Musculoskeletal ultrasound will examine specifically the aponeurosis of the erector spinae and the posterior layer of the thoracolumbar fascia at T11, T12, and L1. These areas will be graded on a 4-point scale (0 to 3), evaluating compressibility and heterogeneity of the tissue.

Participants who have myofascial damage identified on ultrasound and are scheduled for injection treatment as part of normal clinical care will have a diagnostic injection of prolotherapy (0.3% lidocaine + 15% dextrose) in those areas as the first step of the procedure. Pre and post injection muscle testing will be performed. The treatment session then will be completed per normal clinical care; this may include injection at other locations and injection of autologous platelet-rich plasma. Routine follow-up will be scheduled at 3 months.

At 3 months, the follow-up visit will include the following: the same pain scale questionnaire; a follow-up questionnaire to assess changes in function and pain medication; physical examination as before; musculoskeletal ultrasound in the specified areas.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > or = 18 years old
  • Chronic lower back pain > or = 12 weeks duration

排除标准

  • History of stroke preventing bilateral muscle strength testing
  • History of scoliosis that may affect myofascial dynamics
  • Acute radiculopathy/sciatica or pain that limits movement for physical examination
  • Unable to lie prone for physical examination

结局指标

主要结局

MSK Ultrasound

时间窗: At baseline and at 3 month follow-up

Musculoskeletal ultrasound will evaluate specific areas in the lower back on a 4-point scale (0 to 3), evaluating compressibility and heterogeneity of the tissue. The scale is described as follows: 0= No significant compressibility (well defined) 1. Mild compressibility but no translation (heterogeneous) 2. Moderate compressibility, mild translation (heterogeneous, poorly organized) 3. Significant compressibility and translation (heterogeneous, poorly organized) The results from each of the areas evaluated will then be summed for a total composite score. All values, including the individual area score and total composite score, will be recorded. Higher scores are considered worse outcomes. The results of the ultrasound evaluation will be determined solely by the principal investigator.

Pain Scale

时间窗: At baseline and at 3 month follow-up.

Improved lower back pain / functionality. Pain will be discerned on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain the participant has experienced. There will be no subscales provided, and only whole numbers will be allowed to be reported.

次要结局

  • Medications(At baseline and at 3 month follow-up)

研究者

发起方
ProloAustin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bradley D. Fullerton, MD

Adjunct Assistant Professor, Texas A&M College of Medicine

ProloAustin

研究点 (1)

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