Sub-Acute and Chronic Low Back PainNCT00567333
Individualized Chiropractic and Integrative Care for Low Back Pain
A study testing Chiropractic care and Multidisciplinary, integrative care in people with Sub-Acute and Chronic Low Back Pain, run by Northwestern Health Sciences University at 1 site in United States.
Trial summary
This study proposes to compare two innovative treatment approaches for LBP, both of which focus on delivering individualized care through evidence-based, clinical care pathways. The primary aim of the project is to determine the relative clinical efficacy of 1) chiropractic care and 2) multidisciplinary, integrative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sub-Acute and Chronic Low Back Pain
- What is being tested?
- Chiropractic care and Multidisciplinary, integrative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical LBP classified as 1, 2, 3, or 4 using Quebec Task Force (QTF) classification.70 (This includes back pain, stiffness or tenderness with or without musculoskeletal and neurological signs).
- LBP localized to posterior aspect of body, below the costal margin and above the inferior gluteal folds.
- Pain level > 3 on 0 to 10 scale
- Current LBP episode > 6 weeks duration
- 18 years of age and older
- Stable prescription medication plan (No changes in prescription medications that affect musculoskeletal pain in the previous month.)
Who cannot join
- Ongoing treatment for LBP by other non-study providers
- Progressive neurological deficits or cauda equina syndrome
- QTF classifications 5 (spinal instability or fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.
- QTF 7 (Spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).
- Uncontrolled hypertension or metabolic disease
- Blood clotting disorders
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- Severe osteoporosis
- Inflammatory or destructive tissue changes of the spine
- Patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. This is a subgroup of LBP patients which generally have a poorer prognosis.
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Health Sciences University
Bloomington, Minnesota, 55431
About this study
This study proposes to compare two innovative treatment approaches for LBP, both of which focus on delivering individualized care through evidence-based, clinical care pathways.
The primary aim of the project is to determine the relative clinical efficacy of 1) chiropractic care and 2) multidisciplinary, integrative care in 200 patients with sub-acute or chronic LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure in this study is patient-rated back pain.
Read more
Chiropractic care will include therapies within the professional scope of practice. Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional Chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise, and patient education.
Secondary aims are to assess between group differences in frequency of symptoms, disability, fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods and cost-effectiveness and cost utility will be assessed in the short- and long-term.
This innovative study is an exciting collaboration between an experienced and established team of chiropractic, conventional, and CAM professionals dedicated to advancing the care of pervasive and costly LBP conditions. This trial will provide new and important information for all health care providers and LBP patients, informing decision making and improving care delivery systems.
- Conditions
- Sub-Acute and Chronic Low Back Pain
- Being tested
- Chiropractic care, Multidisciplinary, integrative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic careOther
A combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education.
Multidisciplinary, integrative careOther
A combination of therapies which may include acupuncture/Oriental medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and massage therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Other: Chiropractic care |
| 2 | Other | Not described Receives: Other: Multidisciplinary, integrative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated back pain.
Measured: Short term: 12 weeks, Long term: 52 weeks
Secondary outcomes (10)
Frequency of Symptoms
Measured: 12 and 52 weeks
Low Back Disability
Measured: 12 and 52 weeks
Fear Avoidance
Measured: 12 and 52 weeks
Self-Efficacy
Measured: 12 and 52 weeks
General Health Status
Measured: 12 and 52 weeks
Improvement
Measured: 12 and 52 weeks
Patient Satisfaction
Measured: 12 and 52 weeks
Work Loss
Measured: 12 and 52 weeks
Medication Use
Measured: 12 and 52 weeks
Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance.
Measured: Short term: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sub-Acute and 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research
- Responsible party
- Sponsor
- Investigators
- Gert Bronfort, DC, PhD, Principal investigator, Northwestern Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567333
- Sponsor's protocol ID
- R18HP07639
- Other IDs
- R18HP07639
- Status last verified
- May 2015
- First submitted
- 3 Dec 2007
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bronfort G, Maiers M, Schulz C, Leininger B, Westrom K, Angstman G, Evans R. Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial. Chiropr Man Therap. 2022 Mar 1;30(1):10. doi: 10.1186/s12998-022-00419-3.
PubMed 35232482Maiers MJ, Westrom KK, Legendre CG, Bronfort G. Integrative care for the management of low back pain: use of a clinical care pathway. BMC Health Serv Res. 2010 Oct 29;10:298. doi: 10.1186/1472-6963-10-298.
PubMed 21034483Westrom KK, Maiers MJ, Evans RL, Bronfort G. Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach. Trials. 2010 Mar 8;11:24. doi: 10.1186/1745-6215-11-24.
PubMed 20210996
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Chiropractic and Integrative Care for Low Back Pain
- ClinicalTrials.gov ID
- NCT00567333
- Acronym / sponsor ID
- R18HP07639
- Conditions
- Sub-Acute and Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Northwestern Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research
- Study start
- Jun 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Dec 2007 (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.
This study proposes to compare two innovative treatment approaches for LBP, both of which focus on delivering individualized care through evidence-based, clinical care pathways.
The primary aim of the project is to determine the relative clinical efficacy of 1) chiropractic care and 2) multidisciplinary, integrative care in 200 patients with sub-acute or chronic LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure in this study is patient-rated back pain.
Chiropractic care will include therapies within the professional scope of practice. Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional Chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise, and patient education.
Secondary aims are to assess between group differences in frequency of symptoms, disability, fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods and cost-effectiveness and cost utility will be assessed in the short- and long-term.
This innovative study is an exciting collaboration between an experienced and established team of chiropractic, conventional, and CAM professionals dedicated to advancing the care of pervasive and costly LBP conditions. This trial will provide new and important information for all health care providers and LBP patients, informing decision making and improving care delivery systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Chiropractic care |
| 2 | Other | Other: Multidisciplinary, integrative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mechanical LBP classified as 1, 2, 3, or 4 using Quebec Task Force (QTF) classification.70 (This includes back pain, stiffness or tenderness with or without musculoskeletal and neurological signs).
- LBP localized to posterior aspect of body, below the costal margin and above the inferior gluteal folds.
- Pain level > 3 on 0 to 10 scale
- Current LBP episode > 6 weeks duration
- 18 years of age and older
Key exclusion criteria (10 listed)
- Ongoing treatment for LBP by other non-study providers
- Progressive neurological deficits or cauda equina syndrome
- QTF classifications 5 (spinal instability or fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.
- QTF 7 (Spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).
- Uncontrolled hypertension or metabolic disease
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 |
|---|---|---|
| Chiropractic careA combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education. | Other | 1 |
| Multidisciplinary, integrative careA combination of therapies which may include acupuncture/Oriental medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and massage therapy. | Other | 2 |
Primary outcome
Patient-rated back pain.
Time frame: Short term: 12 weeks, Long term: 52 weeks
10 secondary outcomes
Frequency of Symptoms
Time frame: 12 and 52 weeks
Low Back Disability
Time frame: 12 and 52 weeks
Fear Avoidance
Time frame: 12 and 52 weeks
Self-Efficacy
Time frame: 12 and 52 weeks
General Health Status
Time frame: 12 and 52 weeks
Improvement
Time frame: 12 and 52 weeks
Patient Satisfaction
Time frame: 12 and 52 weeks
Work Loss
Time frame: 12 and 52 weeks
Medication Use
Time frame: 12 and 52 weeks
Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance.
Time frame: Short term: 12 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 12 May 2015.
- Derived from this study: PubMed 35232482Bronfort G, Maiers M, Schulz C, Leininger B, Westrom K, Angstman G, Evans R. Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial. Chiropr Man Therap. 2022 Mar 1;30(1):10. doi: 10.1186/s12998-022-00419-3.
- Derived from this study: PubMed 21034483Maiers MJ, Westrom KK, Legendre CG, Bronfort G. Integrative care for the management of low back pain: use of a clinical care pathway. BMC Health Serv Res. 2010 Oct 29;10:298. doi: 10.1186/1472-6963-10-298.
- Derived from this study: PubMed 20210996Westrom KK, Maiers MJ, Evans RL, Bronfort G. Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach. Trials. 2010 Mar 8;11:24. doi: 10.1186/1745-6215-11-24.
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.
Gert Bronfort, DC, PhD principal investigator
Northwestern Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic care and Multidisciplinary, integrative care in people with Sub-Acute and Chronic Low Back Pain, run by Northwestern Health Sciences University 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 6 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 12 May 2015. 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?
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?
Patient-rated back pain. (time frame: Short term: 12 weeks, Long term: 52 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 NCT00567333, which also lists 3 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 12 May 2015.