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Predicting Patients' Response to Spinal Manipulation

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HVLA-SM
LVVA-SM
Usual Medical Care
Sponsored by
Palmer College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Spinal Manipulation

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 21 to 55 Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force. LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement. Written Informed Consent A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points. Exclusion Criteria: LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions). LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis). Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study. Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care. Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity). Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview. Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP. Inability to read or verbally comprehend English. Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility. Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded. Use of manipulative care for any reason within the past 3 months as determined by history: to exclude the possibility of carryover effects. Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy, and massage) for the duration of the study period: to eliminate confounding effects.

Sites / Locations

  • Palmer Center for Chiropractic Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

HVLA-SM

LVVA-SM

Usual Medical Care

Arm Description

HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation

LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation

Usual Medical Care, Active Comparator, advice, exercises and medications

Outcomes

Primary Outcome Measures

Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2006
Last Updated
July 7, 2017
Sponsor
Palmer College of Chiropractic
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT00285649
Brief Title
Predicting Patients' Response to Spinal Manipulation
Official Title
Predicting Patients' Response to Spinal Manipulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 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
Yes

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 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 back 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
Low Back Pain
Keywords
Spinal Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HVLA-SM
Arm Type
Experimental
Arm Description
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
Arm Title
LVVA-SM
Arm Type
Experimental
Arm Description
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
Arm Title
Usual Medical Care
Arm Type
Active Comparator
Arm Description
Usual Medical Care, Active Comparator, advice, exercises and medications
Intervention Type
Other
Intervention Name(s)
HVLA-SM
Intervention Description
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
Intervention Type
Other
Intervention Name(s)
LVVA-SM
Intervention Description
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
Intervention Type
Other
Intervention Name(s)
Usual Medical Care
Intervention Description
Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
Primary Outcome Measure Information:
Title
Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
Description
The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.
Time Frame
Mean change from baseline to week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 21 to 55 Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force. LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement. Written Informed Consent A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points. Exclusion Criteria: LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions). LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis). Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study. Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care. Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity). Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview. Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP. Inability to read or verbally comprehend English. Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility. Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded. Use of manipulative care for any reason within the past 3 months as determined by history: to exclude the possibility of carryover effects. Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy, and massage) for the duration of the study period: to eliminate confounding effects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C Meeker, DC, M.P.H.
Organizational Affiliation
Palmer Chiropractic College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Wilder, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palmer Center for Chiropractic Research
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26656041
Citation
Xia T, Long CR, Gudavalli MR, Wilder DG, Vining RD, Rowell RM, Reed WR, DeVocht JW, Goertz CM, Owens EF Jr, Meeker WC. Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation. Spine (Phila Pa 1976). 2016 Jun;41(12):E702-E709. doi: 10.1097/BRS.0000000000001373.
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
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/26656041
Description
Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation.

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Predicting Patients' Response to Spinal Manipulation

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