Geriatrics Balance and Low Back Pain Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Geriatric Balance and Low Back Pain and Balance Assessment and Management

Conditions
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Distorted Balance, Low Back Pain

Intervention / Treatment
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* Other: chiropractic
* Other: physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chiropractic<br>Chiropractic | Other: chiropractic<br>* chiropractic<br>|
| Active Comparator: Physical therapy<br>Physical therapy | Other: physical therapy<br>* physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient balance parameters at baseline, 6 weeks and 12 weeks. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance, Falls, Low back pain, Geriatric