Preventive Care of Chronic Cervical Pain and Disabilities
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
spinal manipulation
Spinal manipulation + exercises
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility 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.
Sites / Locations
- Université du Québec à Trois-Rivières
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
1
2
3
Arm Description
spinal manipulation
Spinal manipulation + exercises
Outcomes
Primary Outcome Measures
Neck Pain
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
Full Information
NCT ID
NCT00566930
First Posted
November 30, 2007
Last Updated
September 13, 2012
Sponsor
Université du Québec à Trois-Rivières
Collaborators
Foundation for Chiropractic Education and Research (FCER)
1. Study Identification
Unique Protocol Identification Number
NCT00566930
Brief Title
Preventive Care of Chronic Cervical Pain and Disabilities
Official Title
Preventive Care of Chronic Cervical Pain and Disabilities; Comparison of Spinal Manipulative Therapy and Individualized Home Exercise Programs
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec à Trois-Rivières
Collaborators
Foundation for Chiropractic Education and Research (FCER)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
spinal manipulation
Arm Title
3
Arm Type
Experimental
Arm Description
Spinal manipulation + exercises
Intervention Type
Other
Intervention Name(s)
spinal manipulation
Intervention Description
Monthly cervical spinal manipulation
Intervention Type
Other
Intervention Name(s)
Spinal manipulation + exercises
Intervention Description
Monthly cervical spine manipulation and daily home exercises
Primary Outcome Measure Information:
Title
Neck Pain
Description
Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)
Time Frame
Up to 10 months
Secondary Outcome Measure Information:
Title
Fear Avoidance Belief, Quality of Life, Range of Motion
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Descarreaux, PhD
Organizational Affiliation
Université du Québec à Trois-Rivières
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université du Québec à Trois-Rivières
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 1R2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21303529
Citation
Martel J, Dugas C, Dubois JD, Descarreaux M. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain. BMC Musculoskelet Disord. 2011 Feb 8;12:41. doi: 10.1186/1471-2474-12-41.
Results Reference
derived
Learn more about this trial
Preventive Care of Chronic Cervical Pain and Disabilities
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