Chronic Low Back Pain Randomized Controlled Trial

NCT02286232 | Completed Phase 3

• 1 other identifier: 14-0610.01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain; stretching exercises

Outcome Measures

Primary Outcomes (1)

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

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

  12 weeks after start of study

Secondary Outcomes (3)

• >=50% improvement in average pain over previous week from 0-10 scale

  12 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

• Roland-Morris Disability Questionnaire (RDQ)

  6 and 24 weeks after start of study

Study Arms (2)

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.

Behavioral: Stretching exercise

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.

Behavioral: Self-care book

Interventions

Stretching exercise BEHAVIORAL

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.

Stretching exercise

Self-care book BEHAVIORAL

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.

Self-care book

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stamford Hospital: lead
• Wilton Family YMCA: collaborator
• New Canaan Community YMCA: collaborator

Study Sites (1)

Stamford Hospital

Stamford, Connecticut, 06902, United States

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marc Brodsky, MD

  Stamford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 7, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)