跳至主要内容
临床试验/NCT05423509
NCT05423509已完成不适用

Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) Treatment in Adolescent Idiopathic Scoliosis (AIS)

University of New Mexico2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Scoliometer Degree

研究概览

简要总结

Randomized controlled trial of participants with scoliosis into standard treatment with observation/bracing and the other group will have the added treatment of dynamic myofascial manipulation for 6 months.

详细描述

The purpose of this study is to conduct a pilot study of the Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) treatment in Adolescent Idiopathic Scoliosis (AIS). The investigators propose the implementation of Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) protocol can (a) decrease and/or reduce progression of spinal curvatures, (b) reduce degree of anatomical rib hump deformity common in AIS, (c) decrease incidence of patients requiring corrective bracing and/or corrective spinal surgery, (d) significantly reduce AIS-associated pain, and (e) improve quality of life for AIS participants.

This study will test whether DMAMR produces clinically relevant changes in progression of scoliosis curvatures and rib humps, and whether this treatment protocol improves pain scores and quality of life.

Current research has demonstrated unilateral muscle shortening in AIS. Of most importance for this research proposal, research has also identified a set of muscles, portions of which are at an angle to the spine, that are shorter on the concave side of the curvature: the quadratus lumborum, psoas major and minor, and the abdominal obliques. The researchers have suggested this is a compensatory effect of the spinal deformities seen1. The investigators agree that unilateral muscle shortening is present in AIS but the investigators suggest that this asymmetry represents differences between muscle tension on either side of the spine and results in a tethering effect on the spine itself. Supporting a finding of the importance of these muscle imbalances, research using individualized physical therapeutic exercise programs to balance these types of muscle imbalances has demonstrated effectiveness in AIS treatment.

The investigators hypothesize this asymmetrical muscle imbalance, and its resultant tethering effect on the spine, represent myofascial dysfunction. The investigators believe the forces generated by this dysfunction are sufficient to induce worsening of the AIS curvature. The myofascial factors involved in the tethering of the spine in AIS include asymmetrical muscle imbalances involving muscles at an angle to the spine, primarily iliopsoas, quadratus lumborum, abdominal obliques, latissimus dorsi, and anterior serratus muscles.

Fascia overlies and interpenetrates these muscles. At a critical point, these myofascial imbalances generate sufficient stress on the overlying fascia to create a further contractile force within the fascia itself. The investigators ask whether this contractile force is mediated not only by anatomic shortening of individual muscle groups but also by intrinsic changes in fibroblast gene expression within the fascia itself.

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
Single (Outcomes Assessor)

盲法说明

The follow-up visits were performed by an advanced practice provider that did not know which treatment arm the patient is in.

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 10-15
  • Scoliosis curve of 15-30 degrees on cobb angle
  • Risser stage of 0-2

排除标准

  • outside of age range, cobb angle or maturity level

结局指标

主要结局

Scoliometer Degree

时间窗: At time of enrollment

The degree of rotation measured clinically with a scoliometer

Cobb Angle

时间窗: 6 months from time of enrollment

Cobb angle as measured on x-ray

Pain Scale

时间窗: 6 months from time of enrollment

Question asking each participant about their back pain level using a visual analog scale of 0-10. Zero is no pain and 10 is the worst pain they have ever felt.

SRS-22

时间窗: 6 months from time of enrollment

The SRS-22 or Scoliosis Research Society-22 is a functional survey for the patient to fill out on their scoliosis. This survey has been validated in the literature. It is a 22 question survey on the functional status and pain that a patient experiences. Created by the scoliosis research society. There is a scoring rubric that goes with the survey. This survey has 5 domains that are covered with the minimum score of 22 and the maximum score of 110. The higher the score the better the patient is doing in the domains of: Activities of Daily Living, Mental Health, Pain, Patient Satisfaction, Positive Affect, Quality of Life, Social Relationships, and Stress/Coping.

次要结局

未报告次要终点

研究者

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

Selina Silva

Associate Professor, Orthopaedic Surgerey

University of New Mexico

研究点 (2)

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