NCT00475787

Brief Summary

The purpose of this study is to determine the effectiveness of Chiropractic management for treatment of chronic lower back pain in older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

December 30, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

3 years

First QC Date

May 17, 2007

Results QC Date

October 21, 2014

Last Update Submit

December 16, 2014

Conditions

Chronic Low Back Pain

Keywords

Older AdultsPatient EducationRandomized Controlled TrialSham procedureSpinal ManipulationVeterans

Outcome Measures

Primary Outcomes (1)

  • Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)

    100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".

    Baseline, 5 weeks

Secondary Outcomes (4)

  • Medical Outcome Study Short Form 36(SF-36) Bodily Pain

    baseline and 5 Weeks

  • Oswestry Disability Index (ODI)

    baseline and 5 weeks

  • Performance of the Timed up and go Test

    baseline and 5 weeks

  • Medical Outcome Study Short Form Physical Functioning Subscale

    baseline and 5 weeks

Study Arms (2)

Spinal Manipulative therapy

EXPERIMENTAL

Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Procedure: Spinal Manipulation

Detuned Ultrasound

SHAM COMPARATOR

Detuned Ultrasound involves utilizing an ultrasound machine that is set to "0 w/cm2" and US gel is applied to the spine for 11 minutes.

Procedure: Detuned Ultrasound

Interventions

Spinal ManipulationPROCEDURE

Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Spinal Manipulative therapy
Detuned UltrasoundPROCEDURE

US machine is turned on and set at "0 w/cm2"

Also known as: Sham Procedure
Detuned Ultrasound

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Pain greater than three months in duration
  • Localized pain to the lumbosacral and gluteal regions and no focal radicular symptoms
  • Pain elicited upon deep palpation of the lumbar erector spinae musculature 4) Pain that can be either exacerbated or relieved by varying body position

You may not qualify if:

  • Patients will be excluded if they have a history of fragility fracture of radiographic evidence of lumbar compression fracture
  • Patient will be excluded if they have undergone a course of previous chiropractic care
  • Severely demented patients, as indicated by their previous medical history and Mini Mental State scores of 22 or less, will not be selected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Western New York Healthcare System at Buffalo

Buffalo, New York, 14215, United States

Location

VA Medical Center, Canandaigua

Canandaigua, New York, 14424, United States

Location

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Limitations and Caveats

1. Sham intervention was that it did involve some tactile stimulation 2. Only VA sites/predominantly male 3. Clinicians not blinded to invention delivered 4. All received educational booklet 5. Consideration of non-specific therapeutic effects

Results Point of Contact

Title
Paul Dougherty, DC
Organization
Canandaigua VA Medical Center
paul.dougherty@va.gov
585-463-2673

Study Officials

  • Paul Dougherty, DC

    VA Medical Center, Canandaigua

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2007

First Posted

May 21, 2007

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

December 30, 2014

Results First Posted

December 30, 2014

Record last verified: 2014-12

Locations

US(2)