Chronic Low Back Pain Randomized Controlled Trial
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 9/26/2018 |
| Start Date: | November 2014 |
| End Date: | September 2018 |
A Randomized Trial Comparing a Stretching/Exercise Program and Learning About Self-care Practices From a Self-care Book for Chronic Low Back Pain
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.
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.
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.
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.
Inclusion Criteria:
- Adults from 18 through 64 years old who have had low back pain on at least half the
days over the previous 6 months
Exclusion Criteria:
- 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.
We found this trial at
1
site
Stamford, Connecticut 06904
Principal Investigator: Marc Brodsky, MD
Phone: 310-883-4184
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