Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269360
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2005-12-21
Brief Title:
Manipulation Exercise and Self-Care for Neck Pain
Sponsor:
Northwestern Health Sciences University
Organization:
Northwestern Health Sciences University
Study Overview
Official Title:
Manipulation Exercise and Self-Care for Neck Pain
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare three treatments for neck pain 1 rehabilitative exercise 2 chiropractic spinal manipulation combined with rehabilitative exercise and 3 self-care education
Detailed Description:
Neck pain is very common afflicting 10 of the population at any given time Despite its significant socioeconomic impact neck pain has been poorly investigated The broad long term objective of this interdisciplinary research is to identify effective therapies for neck pain and to increase our knowledge of this problematic condition This multidisciplinary randomized clinical trial is based on the investigators previous neck pain research and will assess three treatment approaches for chronic neck pain
1 rehabilitative exercise
2 chiropractic spinal manipulation combined with rehabilitative exercise
3 self-care education a minimal intervention control
The primary aim of this study is to examine the relative efficacy of the three interventions in terms of patient-rated outcomes in the short term after 12 weeks and long term after 52 weeks for chronic neck pain Secondary aims are to assess the relative cost-effectiveness and cost utility of the three treatments evaluate changes in objective cervical spine function assess if cervical function is associated with changes in patient-rated outcomes identify predictors of outcome and finally to describe patients interpretations of outcome measures used in clinical trials
Using previously demonstrated recruitment methods 270 participants with chronic neck pain will be recruited Self-reported outcome measures will be collected at baseline and 4 12 26 and 52 weeks objective outcome measures will be assessed by blinded examiners at baseline and 12 weeks
Chiropractic investigators from Northwestern Health Sciences University are collaborating with medical clinicians from the University of Minnesota the Minneapolis Medical Research Foundation and the Pain Assessment and Rehabilitation Center This established team of investigators will work together in all phases of this innovative study leading to dissemination and publication of study results and hypothesis generation for future research This trial will yield important information allowing health care practitioners policy makers and patients to make better-informed decisions regarding treatment choices for chronic neck pain Importantly it will serve to increase the extremely limited research that currently exists for this significant health-care condition
1 rehabilitative exercise
2 chiropractic spinal manipulation combined with rehabilitative exercise
3 self-care education a minimal intervention control
The primary aim of this study is to examine the relative efficacy of the three interventions in terms of patient-rated outcomes in the short term after 12 weeks and long term after 52 weeks for chronic neck pain Secondary aims are to assess the relative cost-effectiveness and cost utility of the three treatments evaluate changes in objective cervical spine function assess if cervical function is associated with changes in patient-rated outcomes identify predictors of outcome and finally to describe patients interpretations of outcome measures used in clinical trials
Using previously demonstrated recruitment methods 270 participants with chronic neck pain will be recruited Self-reported outcome measures will be collected at baseline and 4 12 26 and 52 weeks objective outcome measures will be assessed by blinded examiners at baseline and 12 weeks
Chiropractic investigators from Northwestern Health Sciences University are collaborating with medical clinicians from the University of Minnesota the Minneapolis Medical Research Foundation and the Pain Assessment and Rehabilitation Center This established team of investigators will work together in all phases of this innovative study leading to dissemination and publication of study results and hypothesis generation for future research This trial will yield important information allowing health care practitioners policy makers and patients to make better-informed decisions regarding treatment choices for chronic neck pain Importantly it will serve to increase the extremely limited research that currently exists for this significant health-care condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None