Geriatrics Balance and Low Back Pain Study

January 8, 2014 updated by: Dennis Enix, DC, MBA, Logan College of Chiropractic

Geriatric Balance and Low Back Pain and Balance Assessment and Management

This study evaluates the effect of standard of care treatments (physical therapy versus manual therapy) in older adult patients who have balance problems with or without low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study uses a randomized controlled research design and will enroll up to three hundred patients. Treatment will take place in outpatient facilities. It is hypothesized that among older adults with low back pain manual therapy will reduce low back pain and improve balance more than physical therapy; and that among older adults without low back pain manual therapy and physical therapy will be equally efficacious in improving balance. The results of this study will help to further define effective treatment protocols.

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

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
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Logan College of Chiropractic

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

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between ages 60-85
  • self reported balance problems
  • With or with out low back pain.

Exclusion Criteria:

  • History of recent fracture or surgery of lumbar spine, pelvis, hip or femur
  • History of recent neoplasm (minor skin cancers are not excluded)
  • Acute infectious disease
  • Chronic low back pain persisting for >8 weeks
  • Severe disabling health problems so that patient is not ambulatory
  • Non-mechanical low back pain
  • Recent unstable peripheral vascular disease and or cardiac disease requiring recent hospitalization < 6 months ago
  • Patients with balance problems related to the following: Meniere's disease, vertigo, or vestibular disorders
  • Recent history of self reported substance abuse
  • Ongoing treatment for balance problems or low back pain by chiropractor, physical therapist, or orthopedic physician or other physician.
  • Current use of medication from the following categories: antipsychotics, anxiolytics, and sedative/hypnotics

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
Active Comparator: Chiropractic
Other: chiropractic
chiropractic
Active Comparator: Physical therapy
Other: physical therapy
physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient balance parameters at baseline, 6 weeks and 12 weeks.
Time Frame: Baseline, week 6 and week 12.
Participants complete functional performance tests and self-report questionnaires related to balance, pain, and quality of life. Testing is performed at baseline, after 6 weeks of care, and at 12 weeks. Balance tests included the Berg Balance Scale, The Timed Get up and Go (TGUG) test, Performance-oriented mobility assessment (POMA), NeuroCom Balance assessment tests which included the Limits of Stability (LOS) Test and Modified Clinical test for the sensory integration of Balance (Mod CTSIB).
Baseline, week 6 and week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient pain levels at baseline, 6 weeks and 12 weeks.
Time Frame: Baseline, week 6 and week 12.
Self reported questionnaires include the Falls Efficacy Scale (FES), Tampa Kinesiophobia Scale, Visual analogue scale (VAS), the 21-point Box Pain Scale, the Oswestry Questionnaire, SF-36 Questionnaire
Baseline, week 6 and week 12.

Collaborators and Investigators

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

Sponsor

Logan College of Chiropractic

Collaborators

St. Louis University

Investigators

  • Principal Investigator: Dennis E Enix, DC, MBA, Logan College of Chiropractic

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, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD1002090203
  • R18HP15125 (Other Grant/Funding Number: HRSA)

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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