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临床试验/NCT02286232
NCT02286232已完成3 期

A Randomized Trial Comparing a Stretching/Exercise Program and Learning About Self-care Practices From a Self-care Book for Chronic Low Back Pain

Stamford Hospital2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2014年11月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
78
试验地点
2
主要终点
>=50% improvement in Roland-Morris Disability Questionnaire (RDQ)

研究概览

简要总结

Chronic low back pain is a common condition that can negatively impact quality of life and that lacks highly effective treatment options. The YMCA developed different iterations of a stretching exercise program as a community based treatment for low back pain from 1974-2004. Though anecdotally successful, the YMCA stretching exercise program(s) was not scientifically evaluated for efficacy and became obsolete. The purpose of the study is to test the efficacy of a previously popular YMCA stretching exercise program(s) for back pain. The stretching exercise program that will be studied is a collection of all the resources available for the YMCA stretching exercise program(s). The most recent criteria from a National Institutes of Health sponsored Task Force to study chronic low back pain were applied to this study.

详细描述

The study will employ a two arm parallel group stratified controlled trial. Statistics were prospectively formulated to compare outcomes of 60 people who completed the study, 30 participants in each intervention group. Subjects from 18 through 64 years old with low back pain on at least half the days over the previous 6 months will be recruited by the Wilton Family YMCA and New Canaan Community YMCA to participate in the study. The participants within each recruitment cohort will be randomized by a sub-investigator who is a statistician to the two treatment arms in a ratio of 1:1 (stretching exercise experimental arm: self-care book active comparator arm). Seven cohorts will receive the intervention stretching exercise program at the Wilton Family YMCA and New Canaan Community YMCA from January 2015 to December 2017. The stretching exercise program consists of 12 standardized weekly stretching exercise sessions that incrementally increase in duration from 15-30 minutes. Participants who receive the stretching exercise intervention will be asked to practice the identical stretches that they did in class on non-class days and will be given handouts and a companion CD to assist in this. Thirty control subjects will receive a self-care book. All analyses will be conducted assuming intent-to-treat principles using SAS statistical software. All P values and 95% CIs will be 2-sided with statistical significance at the P = 0.05 value.

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)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults from 18 through 64 years old who have had low back pain on at least half the days over the previous 6 months

排除标准

  • We will exclude persons whose back pain is attributed to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis.
  • Patients with complex conditions will not participate in the study (eg, sciatica, medicolegal issues, or a previous back surgery).
  • We will also exclude persons who do not speak English.
  • Finally, persons who are unable to attend classes or unwilling to do home practice will be excluded.

研究组 & 干预措施

Stretching exercise

Experimental

A series of 12 standardized, weekly stretching exercise classes will be held at the Wilton Family YMCA, designed for people with chronic low back pain unaccustomed to stretching. Participants will be asked to practice the identical routine of that week's stretching exercise class on off days and will be given handouts and CD's to assist in this.

干预措施: Stretching exercise (Behavioral)

Self-care book

Active Comparator

The Back Pain Helpbook (Moore JE, Lorig K, Von Korff M, Gonzalez VM, Laurent DD. The Back Pain Helpbook. Reading, MA: Perseus Books; 1999)provides information on the causes of back pain and advice on exercising, making appropriate lifestyle modifications, and managing flare-ups.

干预措施: Self-care book (Behavioral)

结局指标

主要结局

>=50% improvement in Roland-Morris Disability Questionnaire (RDQ)

时间窗: 12 weeks after start of study

RDQ is a widely used health status measure for low back pain. Scale is from 0 (least disability) to 24 (most disability)

次要结局

  • Roland-Morris Disability Questionnaire (RDQ)(6 and 24 weeks after start of study)
  • All items derived from PROMIS and STarTBack as suggested by the NIH Task Force(6, 12, and 24 weeks after start of study)
  • >=50% improvement in average pain over previous week from 0-10 scale(12 weeks after start of study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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