- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00566930
Preventive Care of Chronic Cervical Pain and Disabilities
September 13, 2012 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
Preventive Care of Chronic Cervical Pain and Disabilities; Comparison of Spinal Manipulative Therapy and Individualized Home Exercise Programs
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Trois-Rivieres, Quebec, Canada, G9A 1R2
- Université du Québec à Trois-Rivières
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
|
|
Active Comparator: 2
spinal manipulation
|
Monthly cervical spinal manipulation
|
Experimental: 3
Spinal manipulation + exercises
|
Monthly cervical spine manipulation and daily home exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Pain
Time Frame: Up to 10 months
|
Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)
|
Up to 10 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fear Avoidance Belief, Quality of Life, Range of Motion
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Martin Descarreaux, PhD, Université du Québec à Trois-Rivières
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
November 30, 2007
First Submitted That Met QC Criteria
December 3, 2007
First Posted (Estimate)
December 4, 2007
Study Record Updates
Last Update Posted (Estimate)
September 28, 2012
Last Update Submitted That Met QC Criteria
September 13, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chronic cervical pain UQTR
- FCER Grant #06-03-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on spinal manipulation
-
University of FloridaCompleted
-
University of Kansas Medical CenterNational Chiropractic Mutual Insurance Company FoundationCompleted
-
University of Western StatesNational Center for Complementary and Integrative Health (NCCIH)Completed
-
Ignacio Alejandro Astudillo GanoraCompletedBack Pain | Lumbar Pain Syndrome | Back Pain, LowSpain
-
Palmer College of ChiropracticCompleted
-
Université Catholique de LouvainTerminated
-
Grant SandersCompletedSubluxation of Joint of Lumbar Spine
-
Universidade Federal de Sao CarlosFundação de Amparo à Pesquisa do Estado de São PauloCompletedShoulder Impingement SyndromeBrazil
-
University of BrasiliaCompleted
-
DAVID CRUZ DÍAZUnknown