Clinical trial NCT02286232: Chronic Low Back Pain Randomized Controlled Trial
Official title: A Randomized Trial Comparing a Stretching/Exercise Program and Learning About Self-care Practices From a Self-care Book for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
stretching exercises
Lead sponsor: Stamford Hospital
Sponsor class: OTHER
Collaborators: name: Wilton Family YMCA
name: New Canaan Community YMCA
First posted: 2014-11-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: >=50% improvement in Roland-Morris Disability Questionnaire (RDQ)
timeFrame: 12 weeks after start of study
Secondary outcomes:
measure: >=50% improvement in average pain over previous week from 0-10 scale
timeFrame: 12 weeks after start of study
measure: All items derived from PROMIS and STarTBack as suggested by the NIH Task Force
timeFrame: 6, 12, and 24 weeks after start of study
measure: Roland-Morris Disability Questionnaire (RDQ)
timeFrame: 6 and 24 weeks after start of study
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
Study officials:
affiliation: Stamford Hospital
name: Marc Brodsky, MD
role: PRINCIPAL_INVESTIGATOR
References: