NCT02031562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

3.8 years

First QC Date

December 18, 2013

Last Update Submit

January 8, 2014

Conditions

Distorted BalanceLow Back Pain

Keywords

BalanceFallsLow back painGeriatric

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Baseline, week 6 and week 12.

Study Arms (2)

Chiropractic

ACTIVE COMPARATOR

Chiropractic

Other: chiropractic

Physical therapy

ACTIVE COMPARATOR

Physical therapy

Other: physical therapy

Interventions

chiropracticOTHER

chiropractic

Chiropractic
physical therapyOTHER

physical therapy

Physical therapy

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between ages 60-85
  • self reported balance problems
  • With or with out low back pain.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Logan College of Chiropractic

Chesterfield, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, ChiropracticPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsRehabilitation

Study Officials

  • Dennis E Enix, DC, MBA

    Logan College of Chiropractic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2013

First Posted

January 9, 2014

Study Start

October 1, 2009

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(1)