Preventive Care of Chronic Cervical Pain and Disabilities - Tabular View

Tracking Information

First Received Date ^ICMJE

November 30, 2007

Last Updated Date

December 3, 2007

Start Date ^ICMJE

October 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pain, functional disabilities [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00566930 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Fear avoidance belief, Quality of life, Range of motion [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Preventive Care of Chronic Cervical Pain and Disabilities

Official Title ^ICMJE

Preventive Care of Chronic Cervical Pain and Disabilities; Comparison of Spinal Manipulative Therapy and Individualized Home Exercise Programs

Brief Summary

The aim of this study is to determine which of tertiary prevention spinal manipulative therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and increase functional capacity, quality of life and general health condition. To do so, 60 participants with chronic cervical pain, will be recruited and divided into 3 groups according to the intervention they will receive: control group, experimental group 1 who will receive preventive chiropractic care in the form of spinal manipulations and experimental group 2 will have to perform an individualized home exercise program on a daily basis. We hypothesize that a group of patient receiving SMT + a home exercise program will present less pain and functional disabilities over a 1 year period. The innovative value of this project is mainly related to the fact that it will generate new and potentially very useful data concerning the clinical significance of preventive chiropractic care. Moreover, such data will be beneficial to our profession as chiropractic makes a step towards prevention, wellness and public health.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Factorial Assignment

Condition ^ICMJE

Neck Pain

Intervention ^ICMJE

Other: spinal manipulation
Other: Spinal manipulation + exercises

Study Arms / Comparison Groups

Active Comparator: spinal manipulation
Experimental: Spinal manipulation + exercises

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

115

Estimated Completion Date

January 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults between 18 and 60 years old from the city and the surrounding Trois-Rivières with chronic cervical pain of non-traumatic origin (chronic or recurrent cervical pain that lasted at least 6 months)

Exclusion Criteria:

Exclusion criteria for the project are:

Surgery to the cervical spine
Neoplasms
Severe osteoarthritis
Ankylosing spondylitis
Hypertension
Referred pain in the cervical area
Central or peripheric nervous system dysfunction
Vascular disease
Treated cardiovascular disease
Inflammatory or infectious disease of the cervical spine
Metabolic or endocrine diseases
Pregnancy
Specific rehabilitation training for the neck or already under manual therapy for neck pain
Patient suffering from dizziness, vertigo or headache suspected to be cervicogenic or of unknown origin will not be involved in the study.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Martin Descarreaux, PhD

(819) 376-5011 ext 3977

martin.descarreaux@uqtr.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00566930

Responsible Party

Martin Descarreaux, Universite du Quebec a Trois-Rivieres

Study ID Numbers ^ICMJE

Chronic cervical pain UQTR, FCER Grant #06-03-02

Study Sponsor ^ICMJE

Université du Québec à Trois-Rivières

Collaborators ^ICMJE

Foundation for Chiropractic Education and Research (FCER)

Investigators ^ICMJE

Principal Investigator:

Martin Descarreaux, PhD

Université du Québec à Trois-Rivières

Information Provided By

Université du Québec à Trois-Rivières

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP