Subacute Low Back PainPhase 2HRSA4NCT00602901
Elderly Back Pain: Comparing Chiropractic to Medical Care
A Phase 2 study testing HVLA-SM, LVVA-SM and Usual medical care in people with Subacute Low Back Pain and Chronic Low Back Pain, run by Palmer College of Chiropractic at 2 sites in United States.
Trial summary
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 low back pain (LBP). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Subacute Low Back Pain, Chronic Low Back Pain
- What is being tested?
- HVLA-SM, LVVA-SM and Usual medical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 or older
- Idiopathic low back pain (LBP) of at least four weeks duration
- Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders
Who cannot join
- Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis.
- Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse.
- Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition
- Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal manipulative therapy of the arthropathies and significant osteoporosis
- Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory
- Current or pending litigation related to current episode of LBP.
Show all 10Show fewer
- Receiving disability for any health-related condition
- Spinal Manipulative care for any reason within the past month
- Unwilling to postpone use of manual therapies for LBP except those provided in the study for the duration of the study period.
- Unable to read or verbally comprehend English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palmer Center for Chiropractic Research
Davenport, Iowa, 52803
The University of Iowa
Iowa City, Iowa, 52242
About this study
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 low back pain (LBP).
Read the detailed description
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 pack 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.
- Conditions
- Subacute Low Back Pain, Chronic Low Back Pain
- Being tested
- HVLA-SM, LVVA-SM, Usual medical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVLA-SMOther
High-velocity low amplitude spinal manipulation (HVLA-SM)
LVVA-SMOther
Low-velocity variable amplitude spinal manipulation (LVVA-SM)
Usual medical careDrug
Also called (Celebrex, Aleve, Bextra, Naproxen)
Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.
| Study group | Role | What they receive |
|---|---|---|
| HVLA-SM | Experimental | High-velocity low amplitude spinal manipulation (HVLA-SM) Receives: Other: HVLA-SM |
| LVVA-SM | Experimental | Low-velocity variable amplitude spinal manipulation (LVVA-SM) Receives: Other: LVVA-SM |
| Usual Medical Care | Active comparator | Usual medical care - (Celebrex, Aleve, Bextra, Naproxen) Receives: Drug: Usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Questionnaire(RMDQ).
Measured: 6 weeks
Secondary outcomes (7)
Fear Avoidance Beliefs Questionnaire, physical subscale
Measured: 6 weeks, 3 months, 6 months
Visual Analogue Scale for Pain
Measured: 6 weeks
Postural Sway
Measured: 6 weeks
SF-36, v1, Physical Function subscale
Measured: 6 weeks
Posteroanterior Spinal Stiffness
Measured: 6 weeks
Sit-to-Stand Maneuver
Measured: 6 weeks
Spinal Manipulation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJul 2004
- Primary completionOct 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subacute 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palmer College of Chiropractic
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- William C Meeker, DC, M.P.H., Principal investigator, Palmer College of ChiropracticMaria A Hondras, DC, MPH, Study director, Palmer College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602901
- Sponsor's protocol ID
- R18HP01423
- Acronym
- HRSA4
- Status last verified
- Apr 2017
- First submitted
- 15 Jan 2008
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hondras MA, Long CR, Cao Y, Rowell RM, Meeker WC. A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative medical care for adults 55 years and older with subacute or chronic low back pain. J Manipulative Physiol Ther. 2009 Jun;32(5):330-43. doi: 10.1016/j.jmpt.2009.04.012.
PubMed 19539115Hondras 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.
PubMed 18990046
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly Back Pain: Comparing Chiropractic to Medical Care
- ClinicalTrials.gov ID
- NCT00602901
- Acronym / sponsor ID
- HRSA4 / R18HP01423
- Conditions
- Subacute Low Back Pain, Chronic Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Palmer College of ChiropracticUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Jul 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
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 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 low back pain (LBP).
Detailed description
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 pack 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HVLA-SM | Experimental | Other: HVLA-SMHigh-velocity low amplitude spinal manipulation (HVLA-SM) |
| LVVA-SM | Experimental | Other: LVVA-SMLow-velocity variable amplitude spinal manipulation (LVVA-SM) |
| Usual Medical Care | Active comparator | Drug: Usual medical careUsual medical care - (Celebrex, Aleve, Bextra, Naproxen) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 55 or older
- Idiopathic low back pain (LBP) of at least four weeks duration
- Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders
Key exclusion criteria (10 listed)
- Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis.
- Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse.
- Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition
- Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal manipulative therapy of the arthropathies and significant osteoporosis
- Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory
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 |
|---|---|---|
| HVLA-SMHigh-velocity low amplitude spinal manipulation (HVLA-SM) | Other | HVLA-SM |
| LVVA-SMLow-velocity variable amplitude spinal manipulation (LVVA-SM) | Other | LVVA-SM |
| Usual medical careAlso: (Celebrex, Aleve, Bextra, Naproxen)Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks. | Drug | Usual Medical Care |
Primary outcome
Roland Morris Disability Questionnaire(RMDQ).
Time frame: 6 weeks
7 secondary outcomes
Fear Avoidance Beliefs Questionnaire, physical subscale
Time frame: 6 weeks, 3 months, 6 months
Visual Analogue Scale for Pain
Time frame: 6 weeks
Postural Sway
Time frame: 6 weeks
SF-36, v1, Physical Function subscale
Time frame: 6 weeks
Posteroanterior Spinal Stiffness
Time frame: 6 weeks
Sit-to-Stand Maneuver
Time frame: 6 weeks
Spinal Manipulation
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Results publication: PubMed 19539115Hondras MA, Long CR, Cao Y, Rowell RM, Meeker WC. A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative medical care for adults 55 years and older with subacute or chronic low back pain. J Manipulative Physiol Ther. 2009 Jun;32(5):330-43. doi: 10.1016/j.jmpt.2009.04.012.
- Results publication: PubMed 18990046Hondras 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.
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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.
William C Meeker, DC, M.P.H. principal investigator
Palmer College of Chiropractic
Maria A Hondras, DC, MPH study director
Palmer College of Chiropractic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HVLA-SM, LVVA-SM and Usual medical care in people with Subacute Low Back Pain and Chronic Low Back Pain, run by Palmer College of Chiropractic 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 10 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 6 Apr 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Roland Morris Disability Questionnaire(RMDQ). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00602901, which also lists 2 linked publications.
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 6 Apr 2017.