Northwestern Health Sciences University
Bloomington, Minnesota, 55431, United States
NCT Number: NCT01057706
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.
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Notify Me65 year and older
All sexes
Interventional
Phase 2 / Phase 3
Bloomington, Minnesota, 55431, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
spinal manipulation and mobilization
strengthening, stretching, balance
Time frame: 9 months
Time frame: 9 and 18 months
Time frame: 9 and 18 months
Time frame: 9 and 18 months
Time frame: 9 and 18 months
Time frame: 9 and 18 months
Northwestern Health Sciences University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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