Back to resultsGeriatrics Balance and Low Back Pain Study
Primary Purpose
Distorted Balance, Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chiropractic
physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Distorted Balance focused on measuring Balance, Falls, Low back pain, Geriatric
Eligibility Criteria
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
Sites / Locations
- Logan College of Chiropractic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Chiropractic
Physical therapy
Arm Description
Chiropractic
Physical therapy
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02031562
First Posted
December 18, 2013
Last Updated
January 8, 2014
Sponsor
Logan College of Chiropractic
Collaborators
St. Louis University
1. Study Identification
Unique Protocol Identification Number
NCT02031562
Brief Title
Geriatrics Balance and Low Back Pain Study
Official Title
Geriatric Balance and Low Back Pain and Balance Assessment and Management
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Logan College of Chiropractic
Collaborators
St. Louis University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distorted Balance, Low Back Pain
Keywords
Balance, Falls, Low back pain, Geriatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chiropractic
Arm Type
Active Comparator
Arm Description
Chiropractic
Arm Title
Physical therapy
Arm Type
Active Comparator
Arm Description
Physical therapy
Intervention Type
Other
Intervention Name(s)
chiropractic
Intervention Description
chiropractic
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
physical therapy
Primary Outcome Measure Information:
Title
Change in patient balance parameters at baseline, 6 weeks and 12 weeks.
Description
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).
Time Frame
Baseline, week 6 and week 12.
Secondary Outcome Measure Information:
Title
Change in patient pain levels at baseline, 6 weeks and 12 weeks.
Description
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
Time Frame
Baseline, week 6 and week 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis E Enix, DC, MBA
Organizational Affiliation
Logan College of Chiropractic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Logan College of Chiropractic
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
12. IPD Sharing Statement
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Geriatrics Balance and Low Back Pain Study
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