Low Back PainNCT00285649
Predicting Patients' Response to Spinal Manipulation
A study testing HVLA-SM, LVVA-SM and Usual Medical Care in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site 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 LBP. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Mar 2007
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21 to 55
- Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force.
- LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement.
- Written Informed Consent
- A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points.
Who cannot join
- LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions).
- LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis).
- Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study.
- Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care.
- Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity).
- Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview.
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- Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP.
- Inability to read or verbally comprehend English.
- Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility.
- Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded.
- Use of manipulative care for any reason within the past 3 months as determined by history: to exclude the possibility of carryover effects.
- Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy, and massage) for the duration of the study period: to eliminate confounding effects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Palmer Center for Chiropractic Research
Davenport, Iowa, 52803
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 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 back 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
- Low Back Pain
- Being tested
- HVLA-SM, LVVA-SM, Usual Medical Care
- Keywords
- Spinal Manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVLA-SMOther
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
LVVA-SMOther
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
Usual Medical CareOther
Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
| Study group | Role | What they receive |
|---|---|---|
| HVLA-SM | Experimental | HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation Receives: Other: HVLA-SM |
| LVVA-SM | Experimental | LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation Receives: Other: LVVA-SM |
| Usual Medical Care | Active comparator | Usual Medical Care, Active Comparator, advice, exercises and medications Receives: Other: Usual Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.
Measured: Mean change from baseline to week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 192 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 Chiropractic CollegeDavid Wilder, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285649
- Sponsor's protocol ID
- U19P3
- Status last verified
- Jul 2017
- First submitted
- 31 Jan 2006
- Last updated
- 16 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Xia T, Long CR, Gudavalli MR, Wilder DG, Vining RD, Rowell RM, Reed WR, DeVocht JW, Goertz CM, Owens EF Jr, Meeker WC. Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation. Spine (Phila Pa 1976). 2016 Jun;41(12):E702-E709. doi: 10.1097/BRS.0000000000001373.
PubMed 26656041Hondras 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 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Patients' Response to Spinal Manipulation
- ClinicalTrials.gov ID
- NCT00285649
- Acronym / sponsor ID
- U19P3
- Conditions
- Low Back Pain
- Keywords
- Spinal Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 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
- 2 Feb 2006 (estimated)
- Results
- Posted 5 Jul 2017
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 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 back 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 (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HVLA-SM | Experimental | Other: HVLA-SMHVLA-SM, Experimental, high-velocity low amplitude spinal manipulation |
| LVVA-SM | Experimental | Other: LVVA-SMLVVA-SM, Experimental, low velocity variable amplitude spinal manipulation |
| Usual Medical Care | Active comparator | Other: Usual Medical CareUsual Medical Care, Active Comparator, advice, exercises and medications |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 21 to 55
- Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force.
- LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement.
- Written Informed Consent
- A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points.
Key exclusion criteria (12 listed)
- LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions).
- LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis).
- Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study.
- Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care.
- Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity).
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-SMHVLA-SM, Experimental, high-velocity low amplitude spinal manipulation | Other | HVLA-SM |
| LVVA-SMLVVA-SM, Experimental, low velocity variable amplitude spinal manipulation | Other | LVVA-SM |
| Usual Medical CareArm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen) | Other | Usual Medical Care |
Primary outcome
Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
Time frame: Mean change from baseline to week 3
The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26656041Xia T, Long CR, Gudavalli MR, Wilder DG, Vining RD, Rowell RM, Reed WR, DeVocht JW, Goertz CM, Owens EF Jr, Meeker WC. Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation. Spine (Phila Pa 1976). 2016 Jun;41(12):E702-E709. doi: 10.1097/BRS.0000000000001373.
- Derived from this study: 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.
- Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Chiropractic College
David Wilder, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HVLA-SM, LVVA-SM and Usual Medical Care in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site 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 5 inclusion and 12 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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2017). 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?
Roland Morris Low Back Pain Disability Questionnaire (RMDQ) (time frame: Mean change from baseline to week 3). 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 NCT00285649, 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 16 Aug 2017.