An interventional study of Spinal Manipulation and Detuned Ultrasound in Chronic Low Back Pain, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2014-12-30.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 136 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Severely demented patients, as indicated by their previous medical history and Mini Mental State scores of 22 or less, will not be selected.
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Procedure: Spinal Manipulation
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.
Procedure: Detuned Ultrasound
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
US machine is turned on and set at "0 w/cm2"
Also known as: Sham Procedure
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
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
Oswestry Disability Index (ODI)
Validated measure of disability associated with lower back pain.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 5 weeks
| Milestone | Arm 1 | Arm 2 |
|---|---|---|
| Started | 69 | 67 |
| Completed | 61 | 60 |
| Not completed | 8 | 7 |
100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".
| percentage of change from baseline to 5 | Spinal Manipulative Therapy | Sham Group |
|---|---|---|
| Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS) | 26.32 (20.48 to 32.16) | 20.45 (14.18 to 26.71) |
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.
| percentage of change | Arm 1 | Arm 2 |
|---|---|---|
| Medical Outcome Study Short Form 36(SF-36) Bodily Pain | -1.01 (-1.42 to -.6) | -.53 (-.95 to -.11) |
Validated measure of disability associated with lower back pain.
| percentage of change | Arm 1 | Arm 2 |
|---|---|---|
| Oswestry Disability Index (ODI) | 5.45 (2.82 to 8.07) | 3.42 (.08 to 6.04) |
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.
| percentage of change | Arm 1 | Arm 2 |
|---|---|---|
| Performance of the Timed up and go Test | -1.17 (-2.11 to -.23) | -.65 (-1.39 to .09) |
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.
| percentage of change | Spinal Manipulative Therapy | Sham Group |
|---|---|---|
| Medical Outcome Study Short Form Physical Functioning Subscale | -.06 (-.14 to .03) | -.05 (-015 to .04) |
Collected over Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spinal Manipulative Therapy | — | 5/69 (7.2%) | 25/69 (36.2%) |
| Sham Intervention | — | 1/67 (1.5%) | 30/67 (44.8%) |
| Event | Spinal Manipulative Therapy | Sham Intervention |
|---|---|---|
| SyncopeCardiac disorders | 2/69 | 0/67 |
| myocardial infarctionCardiac disorders | 0/69 | 1/67 |
| MyelopathyNervous system disorders | 1/69 | 0/67 |
| Back painMusculoskeletal and connective tissue disorders | 1/69 | 0/67 |
| chest painCardiac disorders | 1/69 | 0/67 |
| Event | Spinal Manipulative Therapy | Sham Intervention |
|---|---|---|
| Back PainMusculoskeletal and connective tissue disorders | 25/25 | 30/67 |
| Joint PainMusculoskeletal and connective tissue disorders | 9/69 | 13/67 |
| leg painMusculoskeletal and connective tissue disorders | 11/69 | 4/67 |
| Age, Continuous(years) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Mean | 77 ± 6.8 | 77 ± 6.81 | 77 ± 6.8 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 68 | 66 | 134 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
US Department of Veterans Affairs