- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057706
Chiropractic and Exercise Management of Spinal Dysfunction in Seniors
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Minnesota
-
Bloomington, Minnesota, United States, 55431
- Northwestern Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 9 months of chiropractic care and exercise
chiropractic, exercise
|
spinal manipulation and mobilization
strengthening, stretching, balance
|
Active Comparator: 3 months of chiropractic care and exercise
chiropractic, exercise
|
spinal manipulation and mobilization
strengthening, stretching, balance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient-rated neck and back disability
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain
Time Frame: 9 and 18 months
|
9 and 18 months
|
Improvement
Time Frame: 9 and 18 months
|
9 and 18 months
|
General health
Time Frame: 9 and 18 months
|
9 and 18 months
|
Medication use
Time Frame: 9 and 18 months
|
9 and 18 months
|
Satisfaction
Time Frame: 9 and 18 months
|
9 and 18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michele Maiers, DC, MPH, Northwestern Health Sciences University
Publications and helpful links
General 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.
- Vihstadt 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R18HP15127
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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