NCT00269321

Chiropractic and Exercise for Seniors With Low Back Pain

Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Northwestern Health Sciences University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.

Detailed description

Low back pain (LBP) is a significant health problem for both young and geriatric individuals. Of particular concern is that conditions associated with LBP, such as impaired strength and flexibility, can have very serious consequences for an older individual's independence and overall health. The broad, long-term objective of this research is to identify effective therapies for low back pain (LBP) and to discover the best methods for enhancing health and functional capacity in the elderly population. This study is a multi-methods clinical trial consisting of a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study nested in the RCT. This trial builds upon a previous study of chiropractic and exercise funded by HRSA, and focuses on elderly patients with sub-acute and chronic low back pain. PRIMARY AIMS * To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term (after 12 weeks) and long-term (after 52 weeks), using low back pain as the main outcome measure 1. chiropractic manual treatment plus home exercise 2. supervised rehabilitative exercise plus home exercise 3. home exercise SECONDARY AIMS * To estimate the short- and long-term relative effectiveness of the three interventions using: * Patient-rated outcomes: low back disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires * Objective functional performance outcomes: spinal motion, trunk strength and endurance, and functional ability measured by examiners masked to treatment group assignment * Cost measures: direct and indirect costs of treatment measured by questionnaires, phone interviews, and medical records. * To describe elderly LBP patients' perceptions of treatment and the issues they consider when determining their satisfaction with care using qualitative methods nested within the RCT.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Chiropractic Manual treatment + home exercise (procedure+behavior)	The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation, mobilization and flexion-distraction therapy with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
PROCEDURE	Supervised rehabilitative exercise+home exercise	The rehabilitative exercise program will consist of 20, 1-hour sessions. It is a modification of exercise protocols used in previous studies by the investigators and incorporates recommendations of leading rehabilitative exercise specialists. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
BEHAVIORAL	Home exercise	Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.

Timeline

• Start date: 2003-10-01
• Completion: 2008-03-01
• First posted: 2005-12-23
• Last updated: 2013-06-28

Locations

1 site across 1 country: United States