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Elderly Back Pain: Comparing Chiropractic to Medical Care (HRSA4)

Primary Purpose

Subacute Low Back Pain, Chronic Low Back Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HVLA-SM

LVVA-SM

Usual medical care

About this trial

This is an interventional treatment trial for Subacute Low Back Pain

Eligibility Criteria

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

Inclusion Criteria:

Age 55 or older
Idiopathic low back pain (LBP) of at least four weeks duration
Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders

Exclusion Criteria:

Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis.
Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse.
Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition
Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal manipulative therapy of the arthropathies and significant osteoporosis
Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory
Current or pending litigation related to current episode of LBP.
Receiving disability for any health-related condition
Spinal Manipulative care for any reason within the past month
Unwilling to postpone use of manual therapies for LBP except those provided in the study for the duration of the study period.
Unable to read or verbally comprehend English.

Sites / Locations

Palmer Center for Chiropractic Research
The University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

HVLA-SM

LVVA-SM

Usual Medical Care

Arm Description

High-velocity low amplitude spinal manipulation (HVLA-SM)

Low-velocity variable amplitude spinal manipulation (LVVA-SM)

Usual medical care - (Celebrex, Aleve, Bextra, Naproxen)

Outcomes

Primary Outcome Measures

Roland Morris Disability Questionnaire(RMDQ).

Secondary Outcome Measures

Fear Avoidance Beliefs Questionnaire, physical subscale

Visual Analogue Scale for Pain

Postural Sway

SF-36, v1, Physical Function subscale

Posteroanterior Spinal Stiffness

Sit-to-Stand Maneuver

Spinal Manipulation

Full Information

NCT ID

NCT00602901

First Posted

January 15, 2008

Last Updated

April 5, 2017

Sponsor

Palmer College of Chiropractic

Collaborators

Department of Health and Human Services

1. Study Identification

Unique Protocol Identification Number

NCT00602901

Brief Title

Elderly Back Pain: Comparing Chiropractic to Medical Care

Acronym

HRSA4

Official Title

Elderly Back Pain: Comparing Chiropractic to Medical Care

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Palmer College of Chiropractic

Collaborators

Department of Health and Human Services

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic low back pain (LBP).

Detailed Description

Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with pack pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subacute Low Back Pain, Chronic Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HVLA-SM

Arm Type

Experimental

Arm Description

High-velocity low amplitude spinal manipulation (HVLA-SM)

Arm Title

LVVA-SM

Arm Type

Experimental

Arm Description

Low-velocity variable amplitude spinal manipulation (LVVA-SM)

Arm Title

Usual Medical Care

Arm Type

Active Comparator

Arm Description

Usual medical care - (Celebrex, Aleve, Bextra, Naproxen)

Intervention Type

Other

Intervention Name(s)

HVLA-SM

Intervention Description

High-velocity low amplitude spinal manipulation (HVLA-SM)

Intervention Type

Other

Intervention Name(s)

LVVA-SM

Intervention Description

Low-velocity variable amplitude spinal manipulation (LVVA-SM)

Intervention Type

Drug

Intervention Name(s)

Usual medical care

Other Intervention Name(s)

(Celebrex, Aleve, Bextra, Naproxen)

Intervention Description

Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.

Primary Outcome Measure Information:

Title

Roland Morris Disability Questionnaire(RMDQ).

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Fear Avoidance Beliefs Questionnaire, physical subscale

Time Frame

6 weeks, 3 months, 6 months

Title

Visual Analogue Scale for Pain

Time Frame

6 weeks

Title

Postural Sway

Time Frame

6 weeks

Title

SF-36, v1, Physical Function subscale

Time Frame

6 weeks

Title

Posteroanterior Spinal Stiffness

Time Frame

6 weeks

Title

Sit-to-Stand Maneuver

Time Frame

6 weeks

Title

Spinal Manipulation

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 55 or older Idiopathic low back pain (LBP) of at least four weeks duration Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders Exclusion Criteria: Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis. Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse. Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal manipulative therapy of the arthropathies and significant osteoporosis Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory Current or pending litigation related to current episode of LBP. Receiving disability for any health-related condition Spinal Manipulative care for any reason within the past month Unwilling to postpone use of manual therapies for LBP except those provided in the study for the duration of the study period. Unable to read or verbally comprehend English.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William C Meeker, DC, M.P.H.

Organizational Affiliation

Palmer College of Chiropractic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maria A Hondras, DC, MPH

Organizational Affiliation

Palmer College of Chiropractic

Official's Role

Study Director

Facility Information:

Facility Name

Palmer Center for Chiropractic Research

City

Davenport

State/Province

Iowa

ZIP/Postal Code

52803

Country

United States

Facility Name

The University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19539115

Citation

Hondras MA, Long CR, Cao Y, Rowell RM, Meeker WC. A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative medical care for adults 55 years and older with subacute or chronic low back pain. J Manipulative Physiol Ther. 2009 Jun;32(5):330-43. doi: 10.1016/j.jmpt.2009.04.012.

Results Reference

result

PubMed Identifier

18990046

Citation

Hondras MA, Long CR, Haan AG, Spencer LB, Meeker WC. Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center. J Altern Complement Med. 2008 Oct;14(8):983-92. doi: 10.1089/acm.2008.0066.

Results Reference

result

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Elderly Back Pain: Comparing Chiropractic to Medical Care

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