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Geriatrics Balance and Low Back Pain Study

Geriatric Balance and Low Back Pain and Balance Assessment and Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02031562
Enrollment
169
Registered
2014-01-09
Start date
2009-10-31
Completion date
2013-08-31
Last updated
2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distorted Balance, Low Back Pain

Keywords

Balance, Falls, Low back pain, Geriatric

Brief summary

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.

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.

Interventions

chiropractic

OTHERphysical therapy

physical therapy

Sponsors

St. Louis University
CollaboratorOTHER
Logan College of Chiropractic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in patient balance parameters at baseline, 6 weeks and 12 weeks.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

MeasureTime frameDescription
Change in patient pain levels at baseline, 6 weeks and 12 weeks.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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026