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Chiropractic and Exercise for Seniors With Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chiropractic Manual treatment + home exercise ( procedure+behavior)
Supervised rehabilitative exercise + home exercise
Home exercise
Sponsored by
Northwestern Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Randomized, Clinical Trial, Neck Pain, Chiropractic, Manual Therapies, Exercise

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 65 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) Exclusion Criteria: 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Chiropractic Manual Treatment + Home Exercise

Supervised Rehabilitative Exercise + Home Exercise

Home Exercise

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

General Health
Disability
Improvement
Satisfaction
Medication use
Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior

Full Information

First Posted
December 21, 2005
Last Updated
August 22, 2011
Sponsor
Northwestern Health Sciences University
Collaborators
Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00269308
Brief Title
Chiropractic and Exercise for Seniors With Neck Pain
Official Title
Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern Health Sciences University
Collaborators
Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research

4. Oversight

5. Study Description

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.
Detailed Description
Neck pain (NP) is a considerable health problem, affecting both young and elderly individuals. Of particular concern is the negative impact NP may have on the functional ability of the geriatric population, already challenged by decreased mobility and balance associated with ageing. Chiropractic manual treatment and rehabilitative exercise have demonstrated potential for the treatment of NP in younger individuals, but have yet to be rigorously tested in the elderly. The broad, long-term objective of this research is to identify effective therapies for patients, 65 years and older, who suffer with chronic neck pain and to enhance their functional capacity. Primary Aims • To determine the relative clinical effectiveness of 1) chiropractic manual treatment and home exercise, 2) supervised rehabilitative exercise and home exercise, and 3) home exercise alone in both the short-term (after 12 weeks) and long-term (after 52 weeks), using patient-rated neck pain as the main outcome measure. Secondary Aims To estimate the short- and long-term relative effectiveness of the three interventions using: Patient-rated outcomes: neck related disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires; Objective functional performance outcomes: neck motion, strength and endurance, and functional ability measured by examiners masked to treatment group assignment; Cost measures: direct and indirect costs, and cost utility of treatment measured by questionnaires, phone interviews, and medical records. To describe patients' perceptions of treatment and the issues they consider when determining their satisfaction with care. This project is a collective effort by a multidisciplinary team, with an established record of collaborative research in the area of neck and back pain. The results of this study will provide valuable information for elderly neck pain sufferers and the clinicians who treat them.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Randomized, Clinical Trial, Neck Pain, Chiropractic, Manual Therapies, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Chiropractic Manual Treatment + Home Exercise
Arm Title
2
Arm Type
Experimental
Arm Description
Supervised Rehabilitative Exercise + Home Exercise
Arm Title
3
Arm Type
Active Comparator
Arm Description
Home Exercise
Intervention Type
Procedure
Intervention Name(s)
Chiropractic Manual treatment + home exercise ( procedure+behavior)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Supervised rehabilitative exercise + home exercise
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Home exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient-rated pain (0-10 scale, 11 box)
Time Frame
short term = 12 weeks; long term = 52 weeks
Secondary Outcome Measure Information:
Title
General Health
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Disability
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Improvement
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Satisfaction
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Medication use
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior
Time Frame
short term = 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 65 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) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gert Bronfort, DC, PhD
Organizational Affiliation
Northwestern Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27345747
Citation
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.
Results Reference
derived
PubMed Identifier
24225010
Citation
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.
Results Reference
derived
PubMed Identifier
17877825
Citation
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.
Results Reference
derived
Links:
URL
http://www.nwhealth.edu/research/WHCCS/
Description
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Chiropractic and Exercise for Seniors With Neck Pain

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