Chronic Low Back PainNCT00475787
Chiropractic Management of Chronic Lower Back Pain in Older Adults
A study testing Spinal Manipulation and Detuned Ultrasound in people with Chronic Low Back Pain, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of Chiropractic management for treatment of chronic lower back pain in older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Spinal Manipulation and Detuned Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Pain greater than three months in duration
- Localized pain to the lumbosacral and gluteal regions and no focal radicular symptoms
- Pain elicited upon deep palpation of the lumbar erector spinae musculature 4) Pain that can be either exacerbated or relieved by varying body position
Who cannot join
- 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.
- The exclusion criteria are representative of the absolute contraindications for chiropractic management, specifically to mean high velocity, low amplitude spinal manipulation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215
VA Medical Center, Canandaigua
Canandaigua, New York, 14424
About this study
The purpose of this study is to determine the effectiveness of Chiropractic management for treatment of chronic lower back pain in older adults.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Spinal Manipulation, Detuned Ultrasound
- Keywords
- Older Adults, Patient Education, Randomized Controlled Trial, Sham procedure, Spinal Manipulation, Veterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationProcedure or surgery
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Detuned UltrasoundProcedure or surgery
Also called Sham Procedure
US machine is turned on and set at "0 w/cm2"
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manipulative therapy | Experimental | Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Receives: Procedure: Spinal Manipulation |
| 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. Receives: Procedure: Detuned Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline, 5 weeks
Secondary outcomes (4)
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.
Measured: baseline and 5 Weeks
Oswestry Disability Index (ODI)
Validated measure of disability associated with lower back pain.
Measured: 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.
Measured: 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.
Measured: baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startApr 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul Dougherty, DC, Principal investigator, VA Medical Center, Canandaigua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475787
- Sponsor's protocol ID
- CLIN-011-06F
- Status last verified
- Dec 2014
- First submitted
- 17 May 2007
- Last updated
- 30 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Management of Chronic Lower Back Pain in Older Adults
- ClinicalTrials.gov ID
- NCT00475787
- Acronym / sponsor ID
- CLIN-011-06F
- Conditions
- Chronic Low Back Pain
- Keywords
- Older Adults, Patient Education, Randomized Controlled Trial, Sham procedure, Spinal Manipulation, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Posted 30 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulative therapy | Experimental | Procedure: Spinal ManipulationSpinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. |
| Detuned Ultrasound | Sham comparator | Procedure: Detuned UltrasoundDetuned Ultrasound involves utilizing an ultrasound machine that is set to "0 w/cm2" and US gel is applied to the spine for 11 minutes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Pain greater than three months in duration
- Localized pain to the lumbosacral and gluteal regions and no focal radicular symptoms
- Pain elicited upon deep palpation of the lumbar erector spinae musculature 4) Pain that can be either exacerbated or relieved by varying body position
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal ManipulationSpinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. | Procedure or surgery | Spinal Manipulative therapy |
| Detuned UltrasoundAlso: Sham ProcedureUS machine is turned on and set at "0 w/cm2" | Procedure or surgery | Detuned Ultrasound |
Primary outcome
Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)
Time frame: Baseline, 5 weeks
100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".
4 secondary outcomes
Medical Outcome Study Short Form 36(SF-36) Bodily Pain
Time frame: baseline and 5 Weeks
Oswestry Disability Index (ODI)
Time frame: baseline and 5 weeks
Performance of the Timed up and go Test
Time frame: baseline and 5 weeks
Medical Outcome Study Short Form Physical Functioning Subscale
Time frame: baseline and 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dougherty, DC principal investigator
VA Medical Center, Canandaigua
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation and Detuned Ultrasound in people with Chronic Low Back Pain, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS) (time frame: Baseline, 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.