Chronic Low Back Pain Randomized Controlled Trial

Phase 3

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Behavioral: Self-care book; Behavioral: Stretching exercise

• Registration Number: NCT02286232
• Lead Sponsor: Stamford Hospital

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-07
• Primary Completion: 2017-12
• Status Verified: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-care book	Self-care book	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.
Stretching exercise	Stretching exercise	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Roland-Morris Disability Questionnaire (RDQ)	6 and 24 weeks after start of study	Scale is from 0 (least disability) to 24 (most disability)
All items derived from PROMIS and STarTBack as suggested by the NIH Task Force	6, 12, and 24 weeks after start of study	Composite outcomes of parameters of pain, function, and global assessment as recommended by the NIH Task Force on Research Standards for Low Back Pain
>=50% improvement in average pain over previous week from 0-10 scale	12 weeks after start of study	0 (no pain) - 10 (worst imaginable pain)

Trial Locations

Locations (1)

Stamford Hospital; 🇺🇸 Stamford, Connecticut, United States