Clinical trial NCT00566930: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Foundation for Chiropractic Education and Research (FCER)
First posted: 2007-12-04
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Neck Pain
timeFrame: Up to 10 months
Secondary outcomes:
measure: Fear Avoidance Belief, Quality of Life, Range of Motion
timeFrame: One year
Other outcomes:
Locations:
city: Trois-Rivieres
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Martin Descarreaux, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.