Neck DisabilityPhase 2/3NCT01057706
Chiropractic and Exercise Management of Spinal Dysfunction in Seniors
A Phase 2/3 study testing chiropractic and exercise in people with Neck Disability and Back Disability, run by Northwestern Health Sciences University at 1 site in United States.
Trial summary
This study will compare the effectiveness of chiropractic and exercise treatment in the short- and long-term, when managing chronic neck and back disability in seniors over the age of 65 years. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neck Disability, Back Disability
- What is being tested?
- chiropractic and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2014
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age and older
- independent ambulation and community dwelling
- stable medication plan
- neck-related disability (minimal score of 10% on Neck Disability Index)
- back-related disability (minimal score of 10% on Oswestry Disability Index)
- minimum combined disability score (above) of 25% at first baseline screening
- at least 12 week duration of neck and back related disability
Who cannot join
- moderate or severe cognitive impairment
- untreated clinical depression
- surgical spinal fusion or multiple incidents of spinal surgery
- contraindications to spinal manipulation or exercise
- ongoing, non-pharmacological treatment for a spinal condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Health Sciences University
Bloomington, Minnesota, 55431
About this study
This study will compare the effectiveness of chiropractic and exercise treatment in the short- and long-term, when managing chronic neck and back disability in seniors over the age of 65 years.
Read the detailed description
Interventions that temper declining functional status due to aging are critical to the vitality and longevity of the elderly. Conservative, non-drug treatments that address disability and pain may significantly reduce the societal burden associated with spinal dysfunction in this population. Chiropractic and exercise are two such promising therapies, and have yet to be compared in the context of short- versus long-term management.
Unanticipated recruitment challenges and repeated reductions to the award negatively impacted our ability to implement the study as proposed. After careful deliberation among the study's Steering Committee, and approval by the IRB and funding agency, the study has been modified to a 2-treatment comparison (formerly 3 treatments).
As such, the primary aim of this study is to compare the effectiveness of 3 versus 9 months of chiropractic care and exercise in 200 seniors with chronic spinal dysfunction. The primary outcomes are patient-rated neck and back disability.
Additionally, initial inclusion criteria regarding disability ratings have been relaxed to allow more individuals with global spine-related disability to qualify. Specifically, participants now must have:
- a minimum of 10% disability in both neck and back regions (at least 5/50 on Neck Disability Index (NDI) and Oswestry Disability Index(ODI)) at baseline 1 evaluation, and
- a combined disability (NDI+ODI) score of at least 25/100 at baseline 1 evaluation.
Secondary aims are to assess between-group differences in patient self-reported pain, general health, improvement, self-efficacy, kinesiophobia, satisfaction, medication use, and objective biomechanical outcomes. Seniors' perceptions and experience with treatment will be assessed through qualitative interviews. Finally, the cost-effectiveness and cost-utility of these interventions will be measured.
Additional secondary aims include assessing within group differences in an additional 18 patients randomized to receive 9 months of exercise only in the earlier phase of this study. Outcomes of these aims include the self-report, biomechanical, and qualitative outcomes listed above (with the exception of cost-effectiveness and cost-utility data).
This project will significantly contribute to the evidence base of conservative, non-drug treatments that address disability and pain in seniors with spinal dysfunction. Identification of effective therapies has tremendous potential to substantially improve the functional status, quality of life, and overall health in the aging population.
- Conditions
- Neck Disability, Back Disability
- Being tested
- chiropractic, exercise
- Keywords
- chiropractic, exercise, seniors
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chiropracticOther
spinal manipulation and mobilization
exerciseBehavioural
strengthening, stretching, balance
| Study group | Role | What they receive |
|---|---|---|
| 9 months of chiropractic care and exercise | Experimental | chiropractic, exercise Receives: Other: chiropractic; Behavioral: exercise |
| 3 months of chiropractic care and exercise | Active comparator | chiropractic, exercise Receives: Other: chiropractic; Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated neck and back disability
Measured: 9 months
Secondary outcomes (5)
Pain
Measured: 9 and 18 months
Improvement
Measured: 9 and 18 months
General health
Measured: 9 and 18 months
Medication use
Measured: 9 and 18 months
Satisfaction
Measured: 9 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2013
- Study completionDec 2014
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 Neck DisabilityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Michele Maiers, Northwestern Health Sciences University
- Investigators
- Michele Maiers, DC, MPH, Principal investigator, Northwestern Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057706
- Sponsor's protocol ID
- R18HP15127
- Status last verified
- May 2015
- First submitted
- 26 Jan 2010
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maiers M, Hartvigsen J, Evans R, Westrom K, Wang Q, Schulz C, Leininger B, Bronfort G. Short- or Long-Term Treatment of Spinal Disability in Older Adults With Manipulation and Exercise. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1516-1524. doi: 10.1002/acr.23798.
PubMed 30354023Vihstadt C, Maiers M, Westrom K, Bronfort G, Evans R, Hartvigsen J, Schulz C. Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms. Chiropr Man Therap. 2014 Jul 23;22:26. doi: 10.1186/s12998-014-0026-7. eCollection 2014.
PubMed 25478141
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic and Exercise Management of Spinal Dysfunction in Seniors
- ClinicalTrials.gov ID
- NCT01057706
- Acronym / sponsor ID
- R18HP15127
- Conditions
- Neck Disability, Back Disability
- Keywords
- chiropractic, exercise, seniors
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Northwestern Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Jan 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Jan 2010 (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 will compare the effectiveness of chiropractic and exercise treatment in the short- and long-term, when managing chronic neck and back disability in seniors over the age of 65 years.
Detailed description
Interventions that temper declining functional status due to aging are critical to the vitality and longevity of the elderly. Conservative, non-drug treatments that address disability and pain may significantly reduce the societal burden associated with spinal dysfunction in this population. Chiropractic and exercise are two such promising therapies, and have yet to be compared in the context of short- versus long-term management.
Unanticipated recruitment challenges and repeated reductions to the award negatively impacted our ability to implement the study as proposed. After careful deliberation among the study's Steering Committee, and approval by the IRB and funding agency, the study has been modified to a 2-treatment comparison (formerly 3 treatments).
As such, the primary aim of this study is to compare the effectiveness of 3 versus 9 months of chiropractic care and exercise in 200 seniors with chronic spinal dysfunction. The primary outcomes are patient-rated neck and back disability.
Additionally, initial inclusion criteria regarding disability ratings have been relaxed to allow more individuals with global spine-related disability to qualify. Specifically, participants now must have:
- a minimum of 10% disability in both neck and back regions (at least 5/50 on Neck Disability Index (NDI) and Oswestry Disability Index(ODI)) at baseline 1 evaluation, and
- a combined disability (NDI+ODI) score of at least 25/100 at baseline 1 evaluation.
Secondary aims are to assess between-group differences in patient self-reported pain, general health, improvement, self-efficacy, kinesiophobia, satisfaction, medication use, and objective biomechanical outcomes. Seniors' perceptions and experience with treatment will be assessed through qualitative interviews. Finally, the cost-effectiveness and cost-utility of these interventions will be measured.
Additional secondary aims include assessing within group differences in an additional 18 patients randomized to receive 9 months of exercise only in the earlier phase of this study. Outcomes of these aims include the self-report, biomechanical, and qualitative outcomes listed above (with the exception of cost-effectiveness and cost-utility data).
This project will significantly contribute to the evidence base of conservative, non-drug treatments that address disability and pain in seniors with spinal dysfunction. Identification of effective therapies has tremendous potential to substantially improve the functional status, quality of life, and overall health in the aging population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9 months of chiropractic care and exercise | Experimental | Other: chiropractic, Behavioral: exercisechiropractic, exercise |
| 3 months of chiropractic care and exercise | Active comparator | Other: chiropractic, Behavioral: exercisechiropractic, exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 65 years of age and older
- independent ambulation and community dwelling
- stable medication plan
- neck-related disability (minimal score of 10% on Neck Disability Index)
- back-related disability (minimal score of 10% on Oswestry Disability Index)
Key exclusion criteria (5 listed)
- moderate or severe cognitive impairment
- untreated clinical depression
- surgical spinal fusion or multiple incidents of spinal surgery
- contraindications to spinal manipulation or exercise
- ongoing, non-pharmacological treatment for a spinal condition
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 |
|---|---|---|
| chiropracticspinal manipulation and mobilization | Other | 3 months of chiropractic care and exercise, 9 months of chiropractic care and exercise |
| exercisestrengthening, stretching, balance | Behavioural | 3 months of chiropractic care and exercise, 9 months of chiropractic care and exercise |
Primary outcome
Patient-rated neck and back disability
Time frame: 9 months
5 secondary outcomes
Pain
Time frame: 9 and 18 months
Improvement
Time frame: 9 and 18 months
General health
Time frame: 9 and 18 months
Medication use
Time frame: 9 and 18 months
Satisfaction
Time frame: 9 and 18 months
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 May 2015.
- Derived from this study: PubMed 30354023Maiers M, Hartvigsen J, Evans R, Westrom K, Wang Q, Schulz C, Leininger B, Bronfort G. Short- or Long-Term Treatment of Spinal Disability in Older Adults With Manipulation and Exercise. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1516-1524. doi: 10.1002/acr.23798.
- Derived from this study: PubMed 25478141Vihstadt C, Maiers M, Westrom K, Bronfort G, Evans R, Hartvigsen J, Schulz C. Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms. Chiropr Man Therap. 2014 Jul 23;22:26. doi: 10.1186/s12998-014-0026-7. eCollection 2014.
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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.
Michele Maiers, DC, MPH 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 Phase 2/3 study testing chiropractic and exercise in people with Neck Disability and Back Disability, 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 5 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 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 neck and back disability (time frame: 9 months). 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 NCT01057706, 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 May 2015.