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临床试验/NCT06126887
NCT06126887已完成不适用

Evaluation of Efficacy and Comfort: A Randomized Clinical Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月9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
100
试验地点
2
主要终点
Brace and sleeve utilization

研究概览

简要总结

The investigators hypothesize that the utilization of Incrediwear's Back Brace, compared to a sham brace and a standard-issue brace, will lead to better brace adherence, increased patient satisfaction, reduced pain medication usage, and improved functional disability among non-surgical chronic LBP patients.

详细描述

Problem: Chronic low back pain (LBP) affects a substantial portion of the population and often leads to decreased functional ability and increased pain medication usage. While back braces have been recommended as part of LBP management, their efficacy and impact on patient outcomes remain uncertain.

Research Hypothesis: The investigators hypothesize that the utilization of Incrediwear's Back Brace, compared to a sham brace and a standard-issue brace, will lead to better brace adherence, increased patient satisfaction, reduced pain medication usage, and improved functional disability among non-surgical chronic LBP patients.

Importance of the Research: This randomized clinical trial aims to assess the efficacy of Incrediwear's Back Brace in improving patient outcomes for chronic LBP. The study will provide valuable insights into the utilization patterns and adherence of back braces, patient satisfaction with treatment protocols, and the impact of brace usage on pain medication consumption and functional disability. By evaluating these factors through a controlled trial, the investigators seek to enhance the understanding of effective LBP management strategies, potentially reducing the burden of chronic LBP on patients and healthcare systems.

The study will be conducted under the guidance of Dr. Akhil Chhatre, Principal Investigator at the Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine. The research will involve 100 non-surgical chronic LBP patients meeting specific inclusion criteria. The patients will be randomly assigned to one of four study groups, and data will be collected through phone calls over a full 4-week duration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Male or female, age > 18
  • Has undergone treatment for an initial episode of nonspecific low back pain (LBP) lasting > 1 month, with one of the following causative "Principle Diagnoses":
  • Disc herniation
  • Facet arthropathy
  • Compression fracture
  • Spondylolisthesis
  • Sacroiliac joint dysfunction
  • Scoliosis
  • Mild to moderate central spinal stenosis
  • Lumbar spondylosis
  • Degenerative changes, not otherwise specified
  • Utilize pain medication (including Step I or II analgesics, NSAIDs, Benzodiazepines) at least weekly for their LBP
  • Subject report a VAS pain score at the time of consent greater than three (>3) out of ten (10)
  • Recommended a back brace for LBP management
  • Provide written consent for participation
  • Subject available for phone calls after 6PM

排除标准

  • Severe central spinal stenosis
  • Focal lower extremity weakness
  • LBP radiating beyond the knee and/or accompanied by neurological signs (including sciatica)
  • Spinal operation within 5 years preceding the study date
  • Secondary LBP due to a work accident (e.g. workers comp)
  • History of spinal arthrodesis
  • LBP with an inflammatory, tumor, or infectious cause
  • Contraindications to: Step I or II analgesics, NSAIDs, Benzodiazepines
  • Diagnosed peripheral arterial disease
  • Higher functions do not enable proper comprehension of protocol or reliable data recording

结局指标

主要结局

Brace and sleeve utilization

时间窗: 1 month

Self-reported hours worn

Pain as assessed by the Visual Analogue Scale (VAS)

时间窗: 1 month

Visual Analogue Scale (VAS) and frequency (ordinal scale). 0 = no pain and 10 = pain as bad as it could possibly be

User Evaluation of Satisfaction as assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)

时间窗: 1 month

Satisfaction (Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 \[QUEST 2.0\] score). The score ranges from 1-5 with 1 being not satisfied at all to 5 being very satisfied

Pain medication name

时间窗: 1 month

The investigators aim to explore the effects of brace utilization on pain medication use. The investigators will document the pain medication name

Pain medication dosage used

时间窗: 1 month

The investigators aim to explore the effects of brace utilization on pain medication use. The investigators will document the pain medication dosage used

Functional disability status as assessed by the Oswestry Disability Index (ODI)

时间窗: 1 month

Oswestry Disability Index (ODI). A total score of 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), 35-50 (completely disabled)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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