Low Back PainPhase 2NCT00269321
Chiropractic and Exercise for Seniors With Low Back Pain
A Phase 2 study testing Chiropractic Manual treatment + home exercise (procedure+behavior), Supervised rehabilitative exercise+home exercise and Home exercise in people with Low Back Pain, run by Northwestern Health Sciences University at 1 site in United States.
Trial summary
The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Chiropractic Manual treatment + home exercise (procedure+behavior), Supervised rehabilitative exercise+home exercise and Home exercise
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Mar 2008
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Sub-Acute and chronic low back pain (Defined as current episode more than 6 weeks duration.)
- Quebec Task Force classifications 1, 2, 3 and 4. (This includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs.{1570})
- 65 years of age and older
- Independent ambulation
- Community dwelling (residency outside nursing home)
- Score of 20 or more on Folstein Mini-Mental State Examination{13246}
- Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)
Who cannot join
- Referred low back pain from local joint lesions of the lower extremities or from visceral diseases
- Significant infectious disease Determined by history or by referral to supplementary diagnostic tests
- Ongoing treatment for low back pain by other health care providers
- Mean baseline low back pain score of 20 percentage points or less
- Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease
- Contraindications to spinal manipulation (i.e. Progressive neurological deficits blood clotting disorders; infectious and non-infectious inflammatory or destructive tissue changes of the spine; severe osteoporosis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University
Bloomington, Minnesota, 55438
About this study
Official title: Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain
The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
Read the detailed description
Low back pain (LBP) is a significant health problem for both young and geriatric individuals. Of particular concern is that conditions associated with LBP, such as impaired strength and flexibility, can have very serious consequences for an older individual's independence and overall health.
The broad, long-term objective of this research is to identify effective therapies for low back pain (LBP) and to discover the best methods for enhancing health and functional capacity in the elderly population. This study is a multi-methods clinical trial consisting of a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study nested in the RCT.
This trial builds upon a previous study of chiropractic and exercise funded by HRSA, and focuses on elderly patients with sub-acute and chronic low back pain.
PRIMARY AIMS
- To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term (after 12 weeks) and long-term (after 52 weeks), using low back pain as the main outcome measure
- chiropractic manual treatment plus home exercise
- supervised rehabilitative exercise plus home exercise
- home exercise SECONDARY AIMS
- To estimate the short- and long-term relative effectiveness of the three interventions using:
- Patient-rated outcomes: low back disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires
- Objective functional performance outcomes: spinal motion, trunk strength and endurance, and functional ability measured by examiners masked to treatment group assignment
- Cost measures: direct and indirect costs of treatment measured by questionnaires, phone interviews, and medical records.
- To describe elderly LBP patients' perceptions of treatment and the issues they consider when determining their satisfaction with care using qualitative methods nested within the RCT.
- Conditions
- Low Back Pain
- Being tested
- Chiropractic Manual treatment + home exercise (procedure+behavior), Supervised rehabilitative exercise+home exercise, Home exercise
- Keywords
- Randomized, Clinical Trial, Low Back Pain, Chiropractic, Manual Therapies, Exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic Manual treatment + home exercise (procedure+behavior)Procedure or surgery
The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation, mobilization and flexion-distraction therapy with light soft tissue massage as indicated to facilitate the manual therapy.
Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
Supervised rehabilitative exercise+home exerciseProcedure or surgery
The rehabilitative exercise program will consist of 20, 1-hour sessions. It is a modification of exercise protocols used in previous studies by the investigators and incorporates recommendations of leading rehabilitative exercise specialists.
Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
Home exerciseBehavioural
Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Chiropractic Manual treatment + home exercise (procedure+behavior) |
| 2 | Experimental | Not described Receives: Procedure: Supervised rehabilitative exercise+home exercise |
| 3 | Active comparator | Not described Receives: Behavioral: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated pain (0-11 box scale)
Measured: short term = 12 weeks; long term = 52 weeks
Secondary outcomes (6)
General Health
Measured: short term = 12 weeks; long term = 52 weeks
Disability
Measured: short term = 12 weeks; long term = 52 weeks
Improvement
Measured: short term = 12 weeks; long term = 52 weeks
Satisfaction
Measured: short term = 12 weeks; long term = 52 weeks
Medication use
Measured: short term = 12 weeks; long term = 52 weeks
Biomechanical test: Lumbar spinal motion Trunk strength & endurance Functional Ability Observed Pain Behavior
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 posted23 Dec 2005 (estimated)
- Study startOct 2003
- Study completionMar 2008
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 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
- Northwestern Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research
- Investigators
- Gert Bronfort, PhD, Principal investigator, Northwestern Health Sciences UniversityRoni Evans, MS, Study director, Northwestern Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269321
- Sponsor's protocol ID
- 5R18HP01424
- Status last verified
- Jun 2013
- First submitted
- 21 Dec 2005
- Last updated
- 28 Jun 2013
- Results posted
- No
Publications
Schulz C, Evans R, Maiers M, Schulz K, Leininger B, Bronfort G. Spinal manipulative therapy and exercise for older adults with chronic low back pain: a randomized clinical trial. Chiropr Man Therap. 2019 May 15;27:21. doi: 10.1186/s12998-019-0243-1. eCollection 2019.
PubMed 31114673Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. doi: 10.1186/1471-2474-8-94.
PubMed 17877825
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT00269321
- Acronym / sponsor ID
- 5R18HP01424
- Conditions
- Low Back Pain
- Keywords
- Randomized, Clinical Trial, Low Back Pain, Chiropractic, Manual Therapies, Exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 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
- Oct 2003
- Study completion
- Mar 2008 (actual)
- First posted
- 23 Dec 2005 (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 randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
Detailed description
Low back pain (LBP) is a significant health problem for both young and geriatric individuals. Of particular concern is that conditions associated with LBP, such as impaired strength and flexibility, can have very serious consequences for an older individual's independence and overall health.
The broad, long-term objective of this research is to identify effective therapies for low back pain (LBP) and to discover the best methods for enhancing health and functional capacity in the elderly population. This study is a multi-methods clinical trial consisting of a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study nested in the RCT.
This trial builds upon a previous study of chiropractic and exercise funded by HRSA, and focuses on elderly patients with sub-acute and chronic low back pain.
PRIMARY AIMS
- To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term (after 12 weeks) and long-term (after 52 weeks), using low back pain as the main outcome measure
- chiropractic manual treatment plus home exercise
- supervised rehabilitative exercise plus home exercise
- home exercise SECONDARY AIMS
- To estimate the short- and long-term relative effectiveness of the three interventions using:
- Patient-rated outcomes: low back disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires
- Objective functional performance outcomes: spinal motion, trunk strength and endurance, and functional ability measured by examiners masked to treatment group assignment
- Cost measures: direct and indirect costs of treatment measured by questionnaires, phone interviews, and medical records.
- To describe elderly LBP patients' perceptions of treatment and the issues they consider when determining their satisfaction with care using qualitative methods nested within the RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Chiropractic Manual treatment + home exercise (procedure+behavior) |
| 2 | Experimental | Procedure: Supervised rehabilitative exercise+home exercise |
| 3 | Active comparator | Behavioral: Home exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Sub-Acute and chronic low back pain (Defined as current episode more than 6 weeks duration.)
- Quebec Task Force classifications 1, 2, 3 and 4. (This includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs.{1570})
- 65 years of age and older
- Independent ambulation
- Community dwelling (residency outside nursing home)
Key exclusion criteria (6 listed)
- Referred low back pain from local joint lesions of the lower extremities or from visceral diseases
- Significant infectious disease Determined by history or by referral to supplementary diagnostic tests
- Ongoing treatment for low back pain by other health care providers
- Mean baseline low back pain score of 20 percentage points or less
- Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled 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 Manual treatment + home exercise (procedure+behavior)The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation, mobilization and flexion-distraction therapy with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active. | Procedure or surgery | 1 |
| Supervised rehabilitative exercise+home exerciseThe rehabilitative exercise program will consist of 20, 1-hour sessions. It is a modification of exercise protocols used in previous studies by the investigators and incorporates recommendations of leading rehabilitative exercise specialists. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active. | Procedure or surgery | 2 |
| Home exercisePatients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active. | Behavioural | 3 |
Primary outcome
Patient-rated pain (0-11 box scale)
Time frame: short term = 12 weeks; long term = 52 weeks
6 secondary outcomes
General Health
Time frame: short term = 12 weeks; long term = 52 weeks
Disability
Time frame: short term = 12 weeks; long term = 52 weeks
Improvement
Time frame: short term = 12 weeks; long term = 52 weeks
Satisfaction
Time frame: short term = 12 weeks; long term = 52 weeks
Medication use
Time frame: short term = 12 weeks; long term = 52 weeks
Biomechanical test: Lumbar spinal motion Trunk strength & endurance Functional Ability Observed Pain Behavior
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 28 Jun 2013.
- Derived from this study: PubMed 31114673Schulz C, Evans R, Maiers M, Schulz K, Leininger B, Bronfort G. Spinal manipulative therapy and exercise for older adults with chronic low back pain: a randomized clinical trial. Chiropr Man Therap. 2019 May 15;27:21. doi: 10.1186/s12998-019-0243-1. eCollection 2019.
- Derived from this study: PubMed 17877825Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. doi: 10.1186/1471-2474-8-94.
- Click here for a description of the Wolfe-Harris for Center for Clinical StudiesLink provided by the sponsor.
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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.
Gert Bronfort, PhD principal investigator
Northwestern Health Sciences University
Roni Evans, MS study director
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 Phase 2 study testing Chiropractic Manual treatment + home exercise (procedure+behavior), Supervised rehabilitative exercise+home exercise and Home exercise in people with 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 7 inclusion and 6 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 28 Jun 2013. 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.
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?
Patient-rated pain (0-11 box scale) (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 NCT00269321, 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 28 Jun 2013.