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Completed

NCT Number: NCT01057706

Chiropractic and Exercise Management of Spinal Dysfunction in Seniors

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Northwestern Health Sciences University

Bloomington, Minnesota, 55431, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chiropractic

Other

spinal manipulation and mobilization

Exercise

Behavioral

strengthening, stretching, balance

Primary outcomes

  1. Patient-rated neck and back disability

    Time frame: 9 months

Secondary outcomes

  1. Pain

    Time frame: 9 and 18 months

  2. Improvement

    Time frame: 9 and 18 months

  3. General health

    Time frame: 9 and 18 months

  4. Medication use

    Time frame: 9 and 18 months

  5. Satisfaction

    Time frame: 9 and 18 months

Sponsors and collaborators

Lead sponsor

Northwestern Health Sciences University

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jan 27, 2010
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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