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临床试验/NCT04543396
NCT04543396进行中(未招募)不适用

Utilization of Tonal Exercise System to Improve Short- and Long-term Low Back Pain (LBP) Outcomes

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Mayo Clinic
入组人数
120
试验地点
2
主要终点
Patient Pain

研究概览

简要总结

This study will assess the effect of incorporating a tonal exercise device into clinical and chiropractic care for lower back pain.

详细描述

All accrued subjects will be assigned study ID numbers to de-identify subject data and keep research team members blinded to group assignments. The CRC will maintain a master keyfile of subject Group randomization that will be revealed to the research team after between-group statistical analyses have been performed.

For all subjects: The active study period for this investigation will be 8 weeks in duration. Passive monitoring will then continue for 12 months after the initial 8 week period. All subjects will continue to receive standard of care treatments from their preferred clinical practitioner (physical therapist, chiropractor, none). All subjects will complete three progress assessments over the duration of the 8-week intervention period. These progress assessments will occur at baseline, week 4, and week 8 and will include the following elements:

  1. Clinical Questionnaires - Clinical questionnaires will be digitally completed by each participant. There will be four (4) clinical questionnaires (Visual Analog Pain Scale, Tampa Scale for Kinesiophobia, PROMIS Physical Function, and PROMIS Pain Interference).

PROMIS Physical Function Questionnaire: Developed by the NIH, this question bank is used to assess patient function. Patients rate each question on a nominal scale from 1-5 related to their ability to complete activities of daily living and exercise. We will use the version 2.0 question bank.

PROMIS Pain Interference: Developed by the NIH, this question band is used to assess the degree to which pain interferes with quality of life and how much pain restricts the patient from activities of daily living and exercise. We will use the version 1.1 question bank.

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 (Investigator)

盲法说明

Investigator will be blinded to subject intervention group assignments.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and Females between ages 18 and 65
  • Seeking physical therapy (PT) or chiropractic care
  • Non-specific LBP
  • Treatment at Mayo Clinic Rchester

排除标准

  • Not able to attend Mayo Clinic Rochester for treatment
  • Women who are pregnant

结局指标

主要结局

Patient Pain

时间窗: 1 year

Subjective assessment of patient pain scores as assessed by a 0-10 Visual Analog Scale, where 0 is no pain and 10 is the worst pain imaginable.

PROMIS Subjective Health Assessment score

时间窗: 2 years

Subjective assessment of patient health performed with the Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test. Scores range from 14.1-61.7 with higher scores representative of better functioning.

Isometric Lumbar Strength

时间窗: 1 year

Maximum lumbar flexion/extension strength as determined with a Humac dynamometer isometric lumbar attachment.

Kinesiophobia

时间窗: 2 years

Subjective assessment of patient fear of movement as assessed by the Tampa Scale of Kinesiophobia questionnaire. Scale is scored from 17-68 where higher scores indicate increased fear of movement.

次要结局

  • Frequency of Back Pain Recurrence(2 years)
  • Functional Strength(1 year)
  • Lumbar Endurance(1 year)

研究者

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

Aaron Krych

Principal Investigator

Mayo Clinic

研究点 (2)

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