Preventive Care of Chronic Cervical Pain and Disabilities

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566930
• Other study ID #: Chronic cervical pain UQTR
• Secondary ID: FCER Grant #06-0
• Status: Completed
• Phase: N/A
• First received: November 30, 2007
• Last updated: September 13, 2012
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2012
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• spinal manipulation
Monthly cervical spinal manipulation
• Spinal manipulation + exercises
Monthly cervical spine manipulation and daily home exercises

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivieres	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières	Foundation for Chiropractic Education and Research (FCER)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Pain	Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)	Up to 10 months	No
Secondary	Fear Avoidance Belief, Quality of Life, Range of Motion		One year	No