Chronic Low Back Pain
Conditions
Keywords
Older Adults, Patient Education, Randomized Controlled Trial, Sham procedure, Spinal Manipulation, Veterans
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.
Interventions
PROCEDURESpinal Manipulation
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
PROCEDUREDetuned Ultrasound
US machine is turned on and set at 0 w/cm2
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS) | Baseline, 5 weeks | 100 mm line with 0 being no pain and 100 mm being the worst pain I can imagine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcome Study Short Form 36(SF-36) Bodily Pain | baseline and 5 Weeks | 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) | baseline and 5 weeks | Validated measure of disability associated with lower back pain. |
| Performance of the Timed up and go Test | baseline and 5 weeks | 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 | baseline and 5 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| Arm 2 Detuned Ultrasound
Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. | 67 |
| Total | 136 |
Baseline characteristics
| Characteristic | Total | Arm 1 | Arm 2 |
|---|---|---|---|
| Age, Continuous | 77 years STANDARD_DEVIATION 6.8 | 77 years STANDARD_DEVIATION 6.8 | 77 years STANDARD_DEVIATION 6.81 |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 134 Participants | 68 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 69 | 30 / 67 |
| serious Total, serious adverse events | 5 / 69 | 1 / 67 |
Outcome results
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.
Time frame: Baseline, 5 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Manipulative Therapy | Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS) | 26.32 percentage of change from baseline to 5 |
| Sham Group | Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS) | 20.45 percentage of change from baseline to 5 |
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.
Time frame: baseline and 5 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Manipulative Therapy | Medical Outcome Study Short Form 36(SF-36) Bodily Pain | -1.01 percentage of change |
| Sham Group | Medical Outcome Study Short Form 36(SF-36) Bodily Pain | -.53 percentage of change |
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.
Time frame: baseline and 5 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Manipulative Therapy | Medical Outcome Study Short Form Physical Functioning Subscale | -.06 percentage of change |
| Sham Group | Medical Outcome Study Short Form Physical Functioning Subscale | -.05 percentage of change |
Secondary
Oswestry Disability Index (ODI)
Validated measure of disability associated with lower back pain.
Time frame: baseline and 5 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Manipulative Therapy | Oswestry Disability Index (ODI) | 5.45 percentage of change |
| Sham Group | Oswestry Disability Index (ODI) | 3.42 percentage of change |
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.
Time frame: baseline and 5 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Manipulative Therapy | Performance of the Timed up and go Test | -1.17 percentage of change |
| Sham Group | Performance of the Timed up and go Test | -.65 percentage of change |