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Chiropractic and Exercise Management of Spinal Dysfunction in Seniors

Chiropractic and Exercise Management of Spinal Dysfunction in Seniors

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01057706
Enrollment
200
Registered
2010-01-27
Start date
2010-01-31
Completion date
2014-12-31
Last updated
2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Disability, Back Disability

Keywords

chiropractic, exercise, seniors

Brief 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.

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: 1. 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 2. 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.

Interventions

spinal manipulation and mobilization

BEHAVIORALexercise

strengthening, stretching, balance

Sponsors

Health Resources and Services Administration (HRSA)
CollaboratorFED
Northwestern Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Patient-rated neck and back disability9 months

Secondary

MeasureTime frame
Pain9 and 18 months
Improvement9 and 18 months
General health9 and 18 months
Medication use9 and 18 months
Satisfaction9 and 18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026