Chiropractic and Exercise Management of Spinal Dysfunction in Seniors

Phase 2

Completed

• Conditions: Neck Disability; Back Disability
• Interventions: Other: chiropractic; Behavioral: exercise

• Registration Number: NCT01057706
• Lead Sponsor: Northwestern Health Sciences University

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Primary Completion: 2013-11
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
9 months of chiropractic care and exercise	exercise	chiropractic, exercise
3 months of chiropractic care and exercise	chiropractic	chiropractic, exercise
3 months of chiropractic care and exercise	exercise	chiropractic, exercise
9 months of chiropractic care and exercise	chiropractic	chiropractic, exercise

Primary Outcome Measures

Name	Time	Method
Patient-rated neck and back disability	9 months

Secondary Outcome Measures

Name	Time	Method
Pain	9 and 18 months
Satisfaction	9 and 18 months
Improvement	9 and 18 months
General health	9 and 18 months
Medication use	9 and 18 months

Trial Locations

Locations (1)

Northwestern Health Sciences University; 🇺🇸 Bloomington, Minnesota, United States