Preventive Care of Chronic Cervical Pain and Disabilities

• Sponsor: Université du Québec à Trois-Rivières (Other)
• Overall Status: Completed
• CT.gov ID: NCT00566930
• Collaborator: Foundation for Chiropractic Education and Research (FCER) (Other)
• Enrollment: 117
• Location: 1
• Arms: 3
• Duration (Months): 11
• Patients Per Site Per Month: 10.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain	Other: spinal manipulation; Other: Spinal manipulation + exercises	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Preventive Care of Chronic Cervical Pain and Disabilities; Comparison of Spinal Manipulative Therapy and Individualized Home Exercise Programs
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1
Active Comparator: 2 spinal manipulation	Other: spinal manipulation; Monthly cervical spinal manipulation
Experimental: 3 Spinal manipulation + exercises	Other: Spinal manipulation + exercises; Monthly cervical spine manipulation and daily home exercises

Outcome Measures

Primary Outcome Measures

1. Neck Pain [Up to 10 months]

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

Secondary Outcome Measures

1. Fear Avoidance Belief, Quality of Life, Range of Motion [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Université du Québec à Trois-Rivières	Trois-Rivieres	Quebec	Canada	G9A 1R2

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Martin Descarreaux, PhD, Université du Québec à Trois-Rivières

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin Descarreaux, Professor, Université du Québec à Trois-Rivières
• ClinicalTrials.gov Identifier: NCT00566930
• Other Study ID Numbers: Chronic cervical pain UQTR; FCER Grant #06-03-02
• First Posted: Dec 4, 2007
• Last Update Posted: Sep 28, 2012
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Neck Pain

Study Results

Participant Flow

Recruitment Details	chripractic clinic
Pre-assignment Detail	117 participants were initially recruited. Following the initial clinical assessment, 98 met all inclusion criteria and were assigned to one of the three groups. 19 participants were excluded because they did not met all inclusion criteria (most common reason was that their neck pain could not be diagnosed as a common non specific neck pain).

Arm/Group Title	Control	Spinal Manipulation	Spinal Manipulation and Exercises
Arm/Group Description	control group with no treatment only regular assessment appointments	spinal manipulation	Spinal manipulation + exercises
Period Title: Overall Study
STARTED	29	36	33
COMPLETED	27	32	32
NOT COMPLETED	2	4	1

Baseline Characteristics

Arm/Group Title	Control	Spinal Manipulation	Spinal Manipulation and Exercises	Total
Arm/Group Description	control group with no treatment only regular assessment appointments	spinal manipulation	Spinal manipulation + exercises	Total of all reporting groups
Overall Participants	29	36	33	98
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	29 100%	36 100%	33 100%	98 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43 (11)	37 (11)	37 (11)	39 (11)
Sex: Female, Male (Count of Participants)
Female	23 79.3%	14 38.9%	14 42.4%	51 52%
Male	6 20.7%	22 61.1%	19 57.6%	47 48%
Region of Enrollment (participants) [Number]
Canada	29 100%	36 100%	33 100%	98 100%

Outcome Measures

1. Secondary Outcome

Title	Fear Avoidance Belief, Quality of Life, Range of Motion
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Spinal Manipulation	Spinal Manipulation and Exercises
Arm/Group Description	control group with no treatment only regular assessment appointments	spinal manipulation	Spinal manipulation + exercises
Measure Participants	29	36	33
Mean (Standard Deviation) [cm]	3.8 (1.9)	3.3 (1.7)	3.4 (1.7)

Adverse Events

Arm/Group Title	Control		Spinal Manipulation		Spinal Manipulation and Exercises
Arm/Group Description	control group with no treatment only regular assessment appointments		spinal manipulation		Spinal manipulation + exercises
All Cause Mortality
	Control		Spinal Manipulation		Spinal Manipulation and Exercises
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Spinal Manipulation		Spinal Manipulation and Exercises
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/36 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Control		Spinal Manipulation		Spinal Manipulation and Exercises
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/36 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.