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Chiropractic Management of Chronic Lower Back Pain in Older Adults

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Manipulation
Detuned Ultrasound
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Older Adults, Patient Education, Randomized Controlled Trial, Sham procedure, Spinal Manipulation, Veterans

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

    • The exclusion criteria are representative of the absolute contraindications for chiropractic management, specifically to mean high velocity, low amplitude spinal manipulation.

Sites / Locations

  • VA Western New York Healthcare System at Buffalo
  • VA Medical Center, Canandaigua

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Spinal Manipulative therapy

Detuned Ultrasound

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Medical Outcome Study Short Form 36(SF-36) Bodily Pain
For the Bodily pain subscale, the higher the number the less self-reported pain. The computed SF-36 pain subscale scores range from 2 to 12.
Oswestry Disability Index (ODI)
Validated measure of disability associated with lower back pain.
Performance of the Timed up and go Test
The Timed Up and Go Test assesses the amount of time it takes an individual to rise from a standard arm chair, walk a distance of 3 meters, and return to the initial position resting against the back of the chair, in this case the measurement was performed utilizing lasers to assess the time to the three meter mark and also the return to sitting in the chair.
Medical Outcome Study Short Form Physical Functioning Subscale
For the Physical Functioning subscale, the higher the number the less self-reported limitations in physical function. The computed SF-36 physical function subscale scores range from 2 to 12.

Full Information

First Posted
May 17, 2007
Last Updated
December 16, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00475787
Brief Title
Chiropractic Management of Chronic Lower Back Pain in Older Adults
Official Title
Chiropractic Management of Chronic Lower Back Pain in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The identification of alternative safe and effective interventions for chronic lower back pain in the elderly is critical in view of its high prevalence, negative impact on quality of life and the treatment risks associated with chronic medication use. This is particularly germane to the veteran population, with a prevalence of lower back pain in excess of 40%. In 1998, published guidelines from the American Geriatric Society listed chiropractic management among the non-pharmacologic strategies for treating chronic pain symptoms in older adults. A recent study showed that a substantial number of older patients who received chiropractic care were less likely to be hospitalized, less likely to have used a nursing home, more likely to report a better health status, more likely to exercise vigorously and more likely to be mobile in the community. Patients undergoing chiropractic care have also reported greater satisfaction as compared to standard medical care. Despite the general clinical acceptance of chiropractic care and satisfaction with chiropractic services, evidence on the potential benefit and safety of chiropractic management of lower back pain in older adults is lacking. The purpose of this study is to evaluate the effectiveness of chiropractic management in older adults with chronic lower back pain, by comparing spinal manipulation to a sham intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Older Adults, Patient Education, Randomized Controlled Trial, Sham procedure, Spinal Manipulation, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Manipulative therapy
Arm Type
Experimental
Arm Description
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Arm Title
Detuned Ultrasound
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal Manipulation
Intervention Description
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Intervention Type
Procedure
Intervention Name(s)
Detuned Ultrasound
Other Intervention Name(s)
Sham Procedure
Intervention Description
US machine is turned on and set at "0 w/cm2"
Primary Outcome Measure Information:
Title
Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)
Description
100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".
Time Frame
Baseline, 5 weeks
Secondary Outcome Measure Information:
Title
Medical Outcome Study Short Form 36(SF-36) Bodily Pain
Description
For the Bodily pain subscale, the higher the number the less self-reported pain. The computed SF-36 pain subscale scores range from 2 to 12.
Time Frame
baseline and 5 Weeks
Title
Oswestry Disability Index (ODI)
Description
Validated measure of disability associated with lower back pain.
Time Frame
baseline and 5 weeks
Title
Performance of the Timed up and go Test
Description
The Timed Up and Go Test assesses the amount of time it takes an individual to rise from a standard arm chair, walk a distance of 3 meters, and return to the initial position resting against the back of the chair, in this case the measurement was performed utilizing lasers to assess the time to the three meter mark and also the return to sitting in the chair.
Time Frame
baseline and 5 weeks
Title
Medical Outcome Study Short Form Physical Functioning Subscale
Description
For the Physical Functioning subscale, the higher the number the less self-reported limitations in physical function. The computed SF-36 physical function subscale scores range from 2 to 12.
Time Frame
baseline and 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. The exclusion criteria are representative of the absolute contraindications for chiropractic management, specifically to mean high velocity, low amplitude spinal manipulation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Dougherty, DC
Organizational Affiliation
VA Medical Center, Canandaigua
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Western New York Healthcare System at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
VA Medical Center, Canandaigua
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424
Country
United States

12. IPD Sharing Statement

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Chiropractic Management of Chronic Lower Back Pain in Older Adults

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