Chronic Low Back Pain Randomized Controlled Trial
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Stretching exercise; Self-care book
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This program begins with 10 stretches/exercises over 15 minutes on the initial class and incrementally increases by 1 stretch/exercise each session for a total of 21 stretches/exercises over 30 minutes on the 12th session. The program is designed to stretch/exercise the major muscle groups, emphasizing the neck and arms, trunk, and legs. In addition to the stretches, each class will include breathing exercises and guided imagery for relaxation. Classes will be taught by Physical Therapists who are trained to lead classes through the protocol.; The Back Pain Helpbook which provides information on the causes of back pain and advice on exercising, making appropriate lifestyle modifications, and managing flare-ups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic low back pain; stretching exercises