Chiropractic and Exercise for Seniors With Low Back Pain - Full Text View

Sponsors and Collaborators:	Northwestern Health Sciences University Health Resources and Services Administration (HRSA) Berman Center for Outcomes and Clinical Research
Information provided by:	Northwestern Health Sciences University
ClinicalTrials.gov Identifier:	NCT00269321

Purpose

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.

Condition	Intervention	Phase
Low Back Pain	Procedure: Chiropractic Manual treatment + home exercise (procedure+behavior) Procedure: Supervised rehabilitative exercise+home exercise Behavioral: Home exercise	Phase II

MedlinePlus related topics: Back Pain Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Northwestern Health Sciences University:

Primary Outcome Measures:

Patient-rated pain (0-11 box scale) [ Time Frame: short term = 12 weeks; long term = 52 weeks ]

Secondary Outcome Measures:

General Health [ Time Frame: short term = 12 weeks; long term = 52 weeks ]
Disability [ Time Frame: short term = 12 weeks; long term = 52 weeks ]
Improvement [ Time Frame: short term = 12 weeks; long term = 52 weeks ]
Satisfaction [ Time Frame: short term = 12 weeks; long term = 52 weeks ]
Medication use [ Time Frame: short term = 12 weeks; long term = 52 weeks ]
Biomechanical test: Lumbar spinal motion Trunk strength & endurance Functional Ability Observed Pain Behavior [ Time Frame: short term = 12 weeks ]

Estimated Enrollment:	240
Study Start Date:	October 2003
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Experimental	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.
2: Experimental	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.
3: Active Comparator	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.

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Sub-Acute and chronic low back pain (Defined as current episode more than 6 weeks duration.)
Quebec Task Force classifications 1, 2, 3 and 4. (This includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs.{1570})
65 years of age and older
Independent ambulation
Community dwelling (residency outside nursing home)
Score of 20 or more on Folstein Mini-Mental State Examination{13246}
Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)

Exclusion Criteria:

Referred low back pain from local joint lesions of the lower extremities or from visceral diseases
Significant infectious disease Determined by history or by referral to supplementary diagnostic tests
Ongoing treatment for low back pain by other health care providers
Mean baseline low back pain score of 20 percentage points or less
Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease
Contraindications to spinal manipulation (i.e. Progressive neurological deficits blood clotting disorders; infectious and non-infectious inflammatory or destructive tissue changes of the spine; severe osteoporosis)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269321

Locations

United States, Minnesota
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University
Bloomington, Minnesota, United States, 55438

Sponsors and Collaborators

Northwestern Health Sciences University

Health Resources and Services Administration (HRSA)

Berman Center for Outcomes and Clinical Research

Investigators

Principal Investigator:	Gert Bronfort, PhD	Northwestern Health Sciences University
Study Director:	Roni Evans, MS	Northwestern Health Sciences University

More Information

Click here for a description of the Wolfe-Harris for Center for Clinical Studies This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94.

Study ID Numbers:	5R18HP01424
Study First Received:	December 21, 2005
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00269321
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern Health Sciences University:

Randomized
Clinical Trial
Low Back Pain

Chiropractic
Manual Therapies
Exercise

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009