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The purpose of this study is to determine the effectiveness of Chiropractic management for treatment of chronic lower back pain in older adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Manipulative therapy | Experimental | Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Manipulation | Procedure | Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 5 Weeks |
| Oswestry Disability Index (ODI) |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Dougherty, DC | VA Medical Center, Canandaigua | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Western New York Healthcare System at Buffalo | Buffalo | New York | 14215 | United States | ||
| VA Medical Center, Canandaigua |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. |
| FG001 | Arm 2 | Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. |
| BG001 | Arm 2 |
| 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 | 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". | Posted | Mean | 95% Confidence Interval | percentage of change from baseline to 5 | Baseline, 5 weeks |
|
Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks).
Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.
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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 | Spinal Manipulative Therapy | Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelopathy | Nervous system disorders | Systematic Assessment | Patient was diagnosed with spondylotic myelopathy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Dougherty, DC | Canandaigua VA Medical Center | 585-463-2673 | paul.dougherty@va.gov |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Detuned Ultrasound | Procedure | US machine is turned on and set at "0 w/cm2" |
|
|
Validated measure of disability associated with lower back pain. |
| baseline and 5 weeks |
| 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. | baseline and 5 weeks |
| 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. | baseline and 5 weeks |
| Canandaigua |
| New York |
| 14424 |
| United States |
Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percentage of change | baseline and 5 Weeks |
|
|
|
| Secondary | Oswestry Disability Index (ODI) | Validated measure of disability associated with lower back pain. | Posted | Mean | 95% Confidence Interval | percentage of change | baseline and 5 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percentage of change | baseline and 5 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percentage of change | baseline and 5 weeks |
|
|
|
| 5 |
| 69 |
| 25 |
| 69 |
| EG001 | Sham Intervention | Detuned Ultrasound | 1 | 67 | 30 | 67 |
|
| Syncope | Cardiac disorders | Systematic Assessment | Cardiac related syncope, not related to study |
|
| myocardial infarction | Cardiac disorders | Systematic Assessment | Unrelated MI |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient fell on ice and injured lower back and neck |
|
| chest pain | Cardiac disorders | Systematic Assessment | Unrelated chest pain |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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