Geriatrics Balance and Low Back Pain Study

Low Back Pain Clinical Trial

Official title:

Geriatric Balance and Low Back Pain and Balance Assessment and Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031562
• Other study ID #: RD1002090203
• Secondary ID: R18HP15125
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: January 8, 2014
• Start date: October 2009
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: Logan College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Distorted Balance
• Low Back Pain

Intervention

Other:
• chiropractic
chiropractic
• physical therapy
physical therapy

Locations

Country	Name	City	State
United States	Logan College of Chiropractic	Chesterfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Logan College of Chiropractic	St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No