Chiropractic and Exercise for Seniors With Low Back Pain

June 27, 2013 updated by: Northwestern Health Sciences University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
Experimental: 2
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.
Active Comparator: 3
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
General Health
Time Frame: short term = 12 weeks; long term = 52 weeks
short term = 12 weeks; long term = 52 weeks
Disability
Time Frame: short term = 12 weeks; long term = 52 weeks
short term = 12 weeks; long term = 52 weeks
Improvement
Time Frame: short term = 12 weeks; long term = 52 weeks
short term = 12 weeks; long term = 52 weeks
Satisfaction
Time Frame: short term = 12 weeks; long term = 52 weeks
short term = 12 weeks; long term = 52 weeks
Medication use
Time Frame: short term = 12 weeks; long term = 52 weeks
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
short term = 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern Health Sciences University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 23, 2005

Study Record Updates

Last Update Posted (Estimate)

June 28, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R18HP01424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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