NCT00566930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

September 14, 2012

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

November 30, 2007

Results QC Date

June 12, 2012

Last Update Submit

September 13, 2012

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Neck Pain

    Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)

    Up to 10 months

Secondary Outcomes (1)

  • Fear Avoidance Belief, Quality of Life, Range of Motion

    One year

Study Arms (3)

1

NO INTERVENTION

2

ACTIVE COMPARATOR

spinal manipulation

Other: spinal manipulation

3

EXPERIMENTAL

Spinal manipulation + exercises

Other: Spinal manipulation + exercises

Interventions

spinal manipulationOTHER

Monthly cervical spinal manipulation

2
Spinal manipulation + exercisesOTHER

Monthly cervical spine manipulation and daily home exercises

3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 1R2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 21303529DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, SpinalExercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Martin Descarreaux
Organization
UQTR
martin.descarreaux@uqtr.ca
819 376-5011

Study Officials

  • Martin Descarreaux, PhD

    Université du Québec à Trois-Rivières

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 28, 2012

Results First Posted

September 14, 2012

Record last verified: 2012-09

Locations

CA(1)