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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVLA-SM | Experimental | HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation |
|
| LVVA-SM | Experimental | LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation |
|
| Usual Medical Care | Active Comparator | Usual Medical Care, Active Comparator, advice, exercises and medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVLA-SM | Other | HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Mean change from baseline to week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William C Meeker, DC, M.P.H. | Palmer Chiropractic College | Principal Investigator |
| David Wilder, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palmer Center for Chiropractic Research | Davenport | Iowa | 52803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26656041 | Result | 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. | |
| 18990046 |
| Label | URL |
|---|---|
| Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation. | View source |
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Participants were recruited primarily through direct mail and local media services.
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| ID | Title | Description |
|---|---|---|
| FG000 | HVLA-SM | HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation |
| FG001 | LVVA-SM | LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation |
| FG002 | Usual Medical Care | Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HVLA-SM | HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation |
| BG001 | LVVA-SM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Mean change from baseline to week 3 |
|
From baseline to follow-up at week 3
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures.
*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HVLA-SM* | HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ting Xia, PhD (Principal Investigator) | Palmer College of Chiropractic | 563-884-5161 | Ting.Xia@palmer.edu |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| LVVA-SM |
| Other |
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation |
|
| Usual Medical Care | Other | Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen) |
|
| 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. |
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
| BG002 | Usual Medical Care | Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Roland-Morris 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. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Usual Medical Care | Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen) |
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 3 |
| 72 |
| EG001 | LVVA-SM* | LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation | 0 | 72 | 0 | 72 | 4 | 72 |
| EG002 | Usual Medical Care* | Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen) | 0 | 48 | 0 | 48 | 5 | 48 |
| Pain/stiffness in the extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |