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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
Université du Québec à Trois-Rivières
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

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)
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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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