Chiropractic and Exercise Management of Spinal Dysfunction in Seniors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Michele Maiers, Northwestern Health Sciences University
ClinicalTrials.gov Identifier:
NCT01057706
First received: January 26, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Neck Disability
Back Disability
Other: chiropractic
Behavioral: exercise
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic and Exercise Management of Spinal Dysfunction in Seniors

Resource links provided by NLM:


Further study details as provided by Northwestern Health Sciences University:

Primary Outcome Measures:
  • Patient-rated neck and back disability [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • Improvement [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • General health [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • Medication use [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]
  • Satisfaction [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 9 months of chiropractic care and exercise
chiropractic, exercise
Other: chiropractic
spinal manipulation and mobilization
Behavioral: exercise
strengthening, stretching, balance
Active Comparator: 3 months of chiropractic care and exercise
chiropractic, exercise
Other: chiropractic
spinal manipulation and mobilization
Behavioral: exercise
strengthening, stretching, balance

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057706

Locations
United States, Minnesota
Northwestern Health Sciences University
Bloomington, Minnesota, United States, 55431
Sponsors and Collaborators
Northwestern Health Sciences University
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Michele Maiers, DC, MPH Northwestern Health Sciences University
  More Information

No publications provided

Responsible Party: Michele Maiers, Faculty, Northwestern Health Sciences University
ClinicalTrials.gov Identifier: NCT01057706     History of Changes
Other Study ID Numbers: R18HP15127
Study First Received: January 26, 2010
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern Health Sciences University:
chiropractic
exercise
seniors

ClinicalTrials.gov processed this record on July 20, 2014