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Completed

NCT Number: NCT02031562

Geriatrics Balance and Low Back Pain Study

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.

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Key information

Conditions

Distorted Balance Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Logan College of Chiropractic

Chesterfield, Missouri, 63017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

chiropractic

Other

chiropractic

Physical Therapy

Other

physical therapy

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Logan College of Chiropractic

Other

Collaborators

  • St. Louis University

Registry information

Official study title

Geriatric Balance and Low Back Pain and Balance Assessment and Management

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2014
Registry last updated
Jan 9, 2014

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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