NCT00269308

Brief Summary

The purpose of this randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2003

Typical duration 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

October 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

4.5 years

First QC Date

December 21, 2005

Last Update Submit

August 22, 2011

Conditions

Neck Pain

Keywords

RandomizedClinical TrialNeck PainChiropracticManual TherapiesExercise

Outcome Measures

Primary Outcomes (1)

  • Patient-rated pain (0-10 scale, 11 box)

    short term = 12 weeks; long term = 52 weeks

Secondary Outcomes (6)

  • General Health

    short term = 12 weeks; long term = 52 weeks

  • Disability

    short term = 12 weeks; long term = 52 weeks

  • Improvement

    short term = 12 weeks; long term = 52 weeks

  • Satisfaction

    short term = 12 weeks; long term = 52 weeks

  • Medication use

    short term = 12 weeks; long term = 52 weeks

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Chiropractic Manual Treatment + Home Exercise

Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior)

2

EXPERIMENTAL

Supervised Rehabilitative Exercise + Home Exercise

Procedure: Supervised rehabilitative exercise + home exercise

3

ACTIVE COMPARATOR

Home Exercise

Behavioral: Home exercise

Interventions

Chiropractic Manual treatment + home exercise ( procedure+behavior)PROCEDURE

The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation and mobilization with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active

1
Supervised rehabilitative exercise + home exercisePROCEDURE

The rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active

2
Home exerciseBEHAVIORAL

Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.

3

Eligibility Criteria

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

You may qualify if:

  • Chronic neck pain (Defined as current episode more than 12 weeks duration.)
  • Quebec Task Force classifications 1, 2, 3 and 4. This includes patients with neck pain, stiffness or tenderness, with or without musculoskeletal and neurological signs.
  • years of age and older
  • Independent ambulation
  • Community dwelling (residency outside nursing home)
  • Score of 20 or more on Folstein Mini-Mental State Examination
  • Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)

You may not qualify if:

  • Referred neck pain from local joint lesions of the upper extremities or from visceral diseases
  • Significant infectious disease
  • Ongoing treatment for neck pain by other health care providers
  • Mean neck pain score of less than 20 percentage points
  • Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease)
  • Contraindications to spinal manipulation (i.e. Progressive neurological deficits, blood clotting disorders, severe osteoporosis, infectious and non-infectious inflammatory or destructive tissue changes of the spine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University

Bloomington, Minnesota, 55431, United States

Location

Related Publications (3)

  • Leininger B, McDonough C, Evans R, Tosteson T, Tosteson AN, Bronfort G. Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain. Spine J. 2016 Nov;16(11):1292-1304. doi: 10.1016/j.spinee.2016.06.014. Epub 2016 Jun 23.

    PMID: 27345747DERIVED

  • Maiers M, Bronfort G, Evans R, Hartvigsen J, Svendsen K, Bracha Y, Schulz C, Schulz K, Grimm R. Spinal manipulative therapy and exercise for seniors with chronic neck pain. Spine J. 2014 Sep 1;14(9):1879-89. doi: 10.1016/j.spinee.2013.10.035. Epub 2013 Nov 10.

    PMID: 24225010DERIVED

  • Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. doi: 10.1186/1471-2474-8-94.

    PMID: 17877825DERIVED

Related Links

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Gert Bronfort, DC, PhD

    Northwestern Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

October 1, 2003

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

US(1)