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Completed

NCT Number: NCT00269321

Chiropractic and Exercise for Seniors With 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University

Bloomington, Minnesota, 55438, United States

About this study

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
  • chiropractic manual treatment plus home exercise
  • supervised rehabilitative exercise plus home exercise
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chiropractic Manual treatment + home exercise (procedure+behavior)

Procedure

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.

Supervised rehabilitative exercise+home exercise

Procedure

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.

Home exercise

Behavioral

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.

Primary outcomes

  1. Patient-rated pain (0-11 box scale)

    Time frame: short term = 12 weeks; long term = 52 weeks

Secondary outcomes

  1. General Health

    Time frame: short term = 12 weeks; long term = 52 weeks

  2. Disability

    Time frame: short term = 12 weeks; long term = 52 weeks

  3. Improvement

    Time frame: short term = 12 weeks; long term = 52 weeks

  4. Satisfaction

    Time frame: short term = 12 weeks; long term = 52 weeks

  5. Medication use

    Time frame: short term = 12 weeks; long term = 52 weeks

  6. Biomechanical test: Lumbar spinal motion Trunk strength & endurance Functional Ability Observed Pain Behavior

    Time frame: short term = 12 weeks

Sponsors and collaborators

Lead sponsor

Northwestern Health Sciences University

Other

Collaborators

  • Berman Center for Outcomes and Clinical Research
  • Health Resources and Services Administration (HRSA)

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2008
First posted
Dec 23, 2005
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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