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Preventive Care of Chronic Cervical Pain and Disabilities

This study has been completed.
Sponsor:
Collaborator:
Foundation for Chiropractic Education and Research (FCER)
Information provided by (Responsible Party):
Martin Descarreaux, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier:
NCT00566930
First received: November 30, 2007
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Neck Pain
 Other: spinal manipulation
Other: Spinal manipulation + exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preventive Care of Chronic Cervical Pain and Disabilities; Comparison of Spinal Manipulative Therapy and Individualized Home Exercise Programs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Université du Québec à Trois-Rivières:

Primary Outcome Measures:
  • Neck Pain [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
    Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)


Secondary Outcome Measures:
  • Fear Avoidance Belief, Quality of Life, Range of Motion [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Active Comparator: 2
spinal manipulation
 Other: spinal manipulation
Monthly cervical spinal manipulation
Experimental: 3
Spinal manipulation + exercises
 Other: Spinal manipulation + exercises
Monthly cervical spine manipulation and daily home exercises

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566930

Locations
Canada, Quebec
Université du Québec à Trois-Rivières
Trois-Rivieres, Quebec, Canada, G9A 1R2
Sponsors and Collaborators
Université du Québec à Trois-Rivières
Foundation for Chiropractic Education and Research (FCER)
Investigators
Principal Investigator: Martin Descarreaux, PhD Université du Québec à Trois-Rivières
  More Information

No publications provided by Université du Québec à Trois-Rivières

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Martin Descarreaux, Professor, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier: NCT00566930     History of Changes
Other Study ID Numbers: Chronic cervical pain UQTR, FCER Grant #06-03-02
Study First Received: November 30, 2007
Results First Received: June 12, 2012
Last Updated: September 13, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013