Geriatrics Balance and Low Back Pain Study

Not Applicable

Completed

• Conditions: Low Back Pain; Distorted Balance
• Interventions: Other: chiropractic; Other: physical therapy

• Registration Number: NCT02031562
• Lead Sponsor: Logan College of Chiropractic

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Study First Submitted: 2013-12-18
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Study First Posted: 2014-01-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chiropractic	chiropractic	Chiropractic
Physical therapy	physical therapy	Physical therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Logan College of Chiropractic; 🇺🇸 Chesterfield, Missouri, United States