NCT01057706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

3.8 years

First QC Date

January 26, 2010

Last Update Submit

May 5, 2015

Conditions

Neck DisabilityBack Disability

Keywords

chiropracticexerciseseniors

Outcome Measures

Primary Outcomes (1)

  • Patient-rated neck and back disability

    9 months

Secondary Outcomes (5)

  • Pain

    9 and 18 months

  • Improvement

    9 and 18 months

  • General health

    9 and 18 months

  • Medication use

    9 and 18 months

  • Satisfaction

    9 and 18 months

Study Arms (2)

9 months of chiropractic care and exercise

EXPERIMENTAL

chiropractic, exercise

Other: chiropracticBehavioral: exercise

3 months of chiropractic care and exercise

ACTIVE COMPARATOR

chiropractic, exercise

Other: chiropracticBehavioral: exercise

Interventions

chiropracticOTHER

spinal manipulation and mobilization

3 months of chiropractic care and exercise9 months of chiropractic care and exercise
exerciseBEHAVIORAL

strengthening, stretching, balance

3 months of chiropractic care and exercise9 months of chiropractic care and exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Health Sciences University

Bloomington, Minnesota, 55431, United States

Location

Related Publications (2)

  • Maiers M, Hartvigsen J, Evans R, Westrom K, Wang Q, Schulz C, Leininger B, Bronfort G. Short- or Long-Term Treatment of Spinal Disability in Older Adults With Manipulation and Exercise. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1516-1524. doi: 10.1002/acr.23798.

    PMID: 30354023DERIVED

  • Vihstadt C, Maiers M, Westrom K, Bronfort G, Evans R, Hartvigsen J, Schulz C. Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms. Chiropr Man Therap. 2014 Jul 23;22:26. doi: 10.1186/s12998-014-0026-7. eCollection 2014.

    PMID: 25478141DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Manipulation, ChiropracticExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michele Maiers, DC, MPH

    Northwestern Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

January 1, 2010

Primary Completion

November 1, 2013

Study Completion

December 1, 2014

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

US(1)